Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 it 1993
510(k) Summary Affirm- VPm NEcrobial Identification Test for Candi4daspecies, Gardnerella vaginalis, and Trichomonas vaginalis
I Establishment: MicroProbe Corporation 1725 220th Street S.E., #104 Bothell, WA 98021 (206) 485-8566 Contact: RusselK. Enns, Ph.D. Director, Technical Affairs Prepared: March 16, 1993
2 Trade Name: Affirmý Win Microbial Identification Test for Candida species, Gardnerella vaginalis, and Ttichomonas vaginalis
Common Name: DNA Probe Test for detectionof Candida species, Gardnerella vaginalis, and Trichomonasvaginalis
Classification Name: Yeast Identification Kit for Candida species:
TrichomonasKit for Dichomonas vaginalis; None for Gardnerella vaginalis
ClassificationNumber:
83M for Candida species; 83JWZ for Trichomonasvaginalis; None for Gardnerella vaginalis
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3 PredicateDevice:
Candidaspecies: Culture: Sabouraud'sDextrose Agar with Chloramphenicol Microscopy: KOH wet mount Gram stain Slide Latex AgglutinationTest: VagiTestO* (Super Duo***IK892802)
Gardnerellavaginalis: Culture: HBT and V agar Microscopy: Gram stain
Trichomonasvaginalis: Culure: Diamond'smedium Microscopy: Salinewet mount
Vagilest* is a registeredtrademark of CentocorDiagnostics
Duo* Super is a registeredtradmark of MarciaDiagnostics Limited
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4 Device Description:
4.1 Explanation of the Test I The MicroProbe Affirmý VPm Microbial Identification Test is basedon the principles of nucleic acid hybridization. Nucleic acid hybridization tests, also known as DNA probe tests, are based on the ability of complementarynucleic acid strandsto align and form specific, double-stranded complexescalled hybrids.
The Affirm- VPmMicrobial IdentificationTest usetwo, single-strandednucleic acid probes, a captureand a color-developmentprobe, that am complementaryto uniquegenetic sequences of eachof the targetorganisms. The captureprobe for eachorganism is immobilizedon a bead thatis embeddedin a cardreferred to asa ProbeAnalysis Card (PAC). Thecolor-development probeis in a multi-well reagentcassette that containsthe test reagents.
The procedureis outlinedin three steps:1) Sampleprepar-ation of the targetorganism nucleic acid;2) automatedassay processing; and 3) testresults reading. During samplepreparation, the sampleis treatedwith Lysis Solutionand then heated. This processruptures the wallsof the organismsreleasing the nucleicacid. A secondsolution, the Buffer Solution,is added;this solution stabilizesthe nucleic acid and establishesthe conditionsnecessary for specific hybridization.The sampleis thenadded to the first well of the ReagentCassette, and automated Affirm- processingbegins. The SampleProcessor moves the PAC from one well of the ReagentCassette to another.Hybridization of the targetnucleic acid to the DNA probeon the targetspecific bead occurs in well 1, andthe hybridizationof the color-developmentDNA probe occursin well 2. All unboundsample components are washedaway in well 3. Enzyme conjugatebinds to the capturedcolor developmentprobe in well 4. Unboundconjugate and probesare washedaway in wells 5 and6. In well 7 the enzymesubstrate is convertedto a blue-coloredproduct if boundenzyme conjugate is presenton the beads.The final step is readingthe color developmenton the beads.
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Affirm' 4.2 Materials Used In the VPui Microbial Identification Test for Candida
species, Gardnerella vaginalis, and Trichomonas vaginalis.
PROBE ANALYSIS CARDS (PACs), 24 Twenty-four individually Probe Analysis Cards (PACs), wrapped in an absorbentpaper towel moistenedwith a solution containing sodium azide (0. 1%,w/v) as a preservative. Each card containsfive beads: Negative Control Tfichomonas Gardnerella Candida Positive Control
REAGENT CASSETTES, 24: Reagentsare sealedin multi-well, foil-covered cassettes. Each cassettehas seven wells. From front to back the wells contain:
Well No. 1: Patient Sample Reservoir, suppliedempty
Well No. 2: Hybridization Solution, 350 t4l: Color development probe Formamide Buffered chaotropic solution
Well No. 3: Wash Solution, 750 i4l: Detergent Buffer solution Preservative: Proctin
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Well No. 4: Conjugate, 500 Al: Enzyme conjugate Preservative: Proclin
Well No. 5: Wash Solution, 750 pl: Detergent Buffer solution Preservative: Proctin
Well No. 6: Wash Solution, 750 IAI: Detergent Buffer solution Preservative: Proclin
Well No. 7: Buffer Solution, 500 pl:
SUBSTRATE SOLUTION, 3.4 ml I bottle, red cap (in foil pouch) Indicator Substrate
Stabilizing agent Alcohol
LYSIS SOLUTION, 9.5 ml I bottle, blue cap Detergent Buffer solution Preservative: Proclin
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BUFFER SOLUTION, 15 ml I bottle, green cap Chaotropic solution Formamide 4 Buffer solution
FILTER TIPS, 24
MATERIALS REQUIRED BUT NOT SUPPLIED
Available from MicroProbe Corporation:
Affirm- VP Sample Collection Set Affirm- Processor
Affirm- Lysis Block (Required to heat samplesfor samplepreparation) Timer Thermometer
5 Significant Performance Characteristics
PERFORMANCECHARACTERISTICS
Affirm' Independentinvestigators evaluated the Viii MicrobialIdentification Test in vaginalsamples. Specimens werefrom women presenting with symptoms of vaginitis/vaginosisor from women at highrisk for infection.
Candidaspecies
Affirm' The sensitivityand specificityof the Wu MicrobialIdentification Test for Candidaspecies were establishedby comparisonto conventionalmicroscopy methods and to culture.The performance of the Affirm-
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VP. MicrobialIdentification Test for Candida-species was determinedin 740 patients. The performanceof the Affirm' ffiii Test for Candidaspecies and microscopy was evaluatedin 479 womenwho presentedwith clinical signs andsymptoms of yeast vaginitisand in 261 high-riskwomen who were evaluated for someother reason, includingpregnancy (n- 186),family planning, or becausethey are contacts of STD-positivepatients. A clinically 10' significantlevel of yeastculture isolation (_ýý cfu perml vaginalfluid) was usedas thecomparative method, sincethis levelhas beenshown, in the literature,to be associatedwith yeast vaginitis. Asymptornatic colonizationat low levelsof yeast is common.1, 21 Raw performancedata are displayedin Table1, and
reconciledperformance data, after discrepantanalysis by an independentmethod, are displayedin Table2.
Table I AffirMT" UnreconciledPerformance of the VPwMicrobial Identification Test, Wet MountAnalysis, and Gramstain to CultureIdentification of Candidaspecies
Test/Culture +/+ +/- Sensitivity Specificity Accuracy N N (TP) (FP) (FN 1+) 1 (TN) N Allpatients (n=740) firMTM 85 26 24 605 78 95.9 93
Wet Mount 59 52 50 579 54 91.8 86 - GramStain (n 484) 1 25 6 35 1 418 42 98.6 92 Forpatients with presenting symptoms of Vaginitis(n=479) firmT" Af 65 20 17 377 79 95.0 92 Wet Mount 55 44 27 353 67 88.9 85
Gram Stain(n-329) 1 23 1 4 1 31 271 43 98.5 89 Forpatients without presenting symptoms of Vaginitis(n=261) AffirmTm 20 6 7 228 74 97.4 95 et ount 4 8 23 226 15 96.6 88 GramStain (N - 155) 2 2 4 147 33 98.7 96 1 1 1 1 1 1
Incases of apparent false positive results where the AffirW Viii was positiveand the comparative result was Affirm' negative,alternate methods were used to confirm the Viiiresult. For example in Table 1, there were Affirm' positive" 85 resultswhich were positive by both culture and by Pin and26 "apparentfalse samples
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Affirm' which were positiveby Wimand negativeby culture. Thesesamples were examinedfor wet mount identificationof yeast. As seenin Table2, 15 of thesesamples were alsowet mountpositive. In thosecases wherethe apparentfalse positives were confirmedby the alternatemethod, the sampleswere moved to the true positivecategory and the reconciledsensitivity and specificityrecalculated and presentedin Table2. Similarly, the Affirm' Um Test was usedto reconcilewet mount"apparent false positive samples". Gram stain was not usedto reconcileapparent false positivesby wet mountbecause it had lowersensitivity in this study. Of the 10' remaining11 apparentfalse positivesamples, 10 were positiveby culture,but at levelsless than cfulml, Affirm' and the eleventhsample was alsopositive in a duplicateswab in a second VPwMicrobial Identification Test for Candidaspecies.
Affirm' Theperformance of the ffiii Test comparedto clinicallysignificant culture as presented in Table8. The sensitivityand specificity was 81%and 98.2%, respectively, as comparedto a sensitivityand specificity of 60% and94.0%, respectively, for wet mountand of 44% and99.3% by Gramstain, respectively, for identification Affirm' of yeastin all women.The Uni Testis moresensitive than either wet mount or Gramstain identification of yeastand at clinicallyrelevant levels.
ClinicalPerformance Stratified By Initial PresentingVaginal Complaint
Additionally,the performance of thesetests was alsoevaluated on the basisof whetherthe womenentered the clinicwith a complaintof vaginitis,or if theywere considered at highrisk of vaginitisand were being seen for someother reason, including pregnancy (n- 186),family planning, or becausethey were contacts of STO-positive patients. The majorityof womenin this trialhad clinical signs and symptoms of vaginitis(640 of 740).
AffirMTm The Test providedmore objective detection of clinicallysignificant levels of yeast.There was a differencein diagnosticperformance by wet mountbased on whetheror not thepatients entered the clinic with symptomsof vaginitisor whetherthe visitoriginated for someother reason. Gram stain evaluation was a less
sensitivemethod of detectingyeast.
Asseen in Table2 for identificationof yeast,in womenwho entered the cliniccomplaining of vaginal symptoms, Affirmý the relativesensitivity and specificity of the VPmTest was 82% and98.4%, as comparedto 72%and
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AffirmTm 92.2%,respectively, for wet mount.These results indicate the two tests, Viii andWet mount,perform similarlyin womenwho enter the cliniccomplaining of vaginitis. Gramstain identificationof yeast was less sensitivethan the other methods,with a sensitivityand specificity of 46% and99.6%, respectively. I
However,in womenwho enteredthe clinic for someother reason,the two tests did not performsimilarly. Of these 261 women,88% were eitherpregnant or had signs or symptomsof vaginitisrecorded during the office Affirm' visit. As seen in Table2, the relativesensitivity and specificityof the Test was 75% and 97.9%, respectively.The sensitivityand specificitywas 18% and 97.0%, respectively,for wet mount and was 33% and98.7% for GramStain, respectively,for identificationof yeast.
The sensitivity of the wet mount evaluation was apparently influencedby whether or not the women entered the clinic complainingof a vaginal infection (respectively);or whether they were seen for some AffirMTm other reason (72% vs 18%, respectively).The sensitivity of the Test was not influencedby whether or not the women enteredthe clinic complaining of a vaginal infection or whether they were seen for some other reason (82% vs 75%, respectively). Since the reference method, clinically significant culture, remaindedthe same in both cases,this data suggestswet mount is more subjective and operator sensitive. Since it is well documentedthat symptomsare not well correlated with yeast AffirMTIA vaginitis', the Mii Test represents an objective measure of clinically significant levels of AffirMTIA yeast in vaginal fluid specimens.The Test results are availableat the time of the office visit. A diagnosis of yeast vaginitis requires the presence of associated clinical signs and symptoms in addition to demonstration of the organism.
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Table2 ReconciledPerformance of the Affirm" Vill Microbial IdentificationTest, Wet Mount Analysis, and Gramstain to CultureIdentification of Candidaspecies
Test vs Culture +1+ +j- -1+ -1- Sensitivity Specificity Accuracy
(TP) (FP) (FN) (TN) N N N
Allpatients (n=740)
AffirmTm lie 100 24 605 81 98.2 95
Wet Mount 74 37' 50 579 60 94.0 88
GramStain (n-484) 28 3 35 418 44 99.3 92 rqrpatients with presenting symptoms of Vaginitis (n=479)
AffirmTM 79 6 17 377 82 98.4 95
Wet Mount 69 30 27 353 72 92.2 88
GramStain (n - 329) 26 1 31 271 46 99.6 90
Forpatients without presenting symptoms of Vaginitis (N=261) AffirMTM 21 5 7 228 75 97.9 95
Wet Mount 5 7 23 226 18 97.0 89
GramStain (N - 155) 2 2 4 147 33 98.7 96
10of 11 samp leswere positi veby culture, buta t <104 yeas t oermi. The e leventhsamole was nositivahv2 dunfir atpAffirm" PinTest. ' 10' 11of 37 samples were positive byculture, butat levels < yeastper mi. Of the remaining 26,1 waspositive bya duplicate AffirmTMTest, 15of 15 were negative ona duplicate smearmade from the same swab as the wet mount.
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Gardnerellavaginalis
Affirm' Fourindependent investigators evaluated the ability of the MicroProbe Viii MicrobialIdentification Test to identify Gardnerella,vaginalisin vaginal samples. The study sites includedthree sexually transmitted disease clinicsand one public health, family-planning clinic. Specimenswere from womenpresenting with symptomsof vaginitisivaginosisor from womenat high risk for infection.
Affirm' The sensitivityand specificityof the Viii MicrobialIdentification Test for Gardnerellavaginalis was establishedby comparisonto conventionalmicroscopy methods and to culturein 299 patients.Culture determinationof Gardnerella vayinalis is notrecommended for the diagnosisof bacterialvaginosis due to the high numberof womenpositive for Gardnerellavaginalis who do not have clinical bacterial vaginosis. Because of this, AffirMTm 105 mi." the Testwas comparedto clinicallysignificant levels of G. vaginalis,identified as > cfu per The performanceof the AffirmTmVNi MicrobialIdentification Test for Gardnerellavaginalis as comparedto standardreference methods is presentedin Table3. Table 3 UnreconciledPerformance of Methodfor Gardnerellavaginalis Identification
AffirMT1 Comparison VP/ReferenceMethod Sensitivity Specificity Agreement +/+ +I- -/+ (FP) (FN) (TN) -I-(TP) ForGardnerella vaginalis, all patients(n-299) AffirMTMvs Gram 167 4 33 95 84% 96% 88% stainMorphotypes; AffirMTMvs Culture 147 24 21 107 88% 82% 85% > 2+
ForGardnerella vaginalis, in patientswith clinicalBV by 3 of 4 Criteria(n - 129) AffirMTMvs Gram 117 1 6 5 95% 83% 95% stain Morphotypes AffirMTM vs Culture 105 13 2 9 98% 41% 88% > 2+
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AffirmTm As with the Test for Candidaspecies, the apparentfalse positive samples which were positiveby the AffirmTm but negativeby the referencemethod were evaluatedby the alternatereference method. For Gardnerellavaginalis, when Gram stain morphotypes was the referencethe discrepantsamples were examined by cultureand when the referencemethod was culture,the discrepantsamples were evaluated by Gramstain morphology.For clue cells the discrepantsamples were also examinedby Gramstain morphotypesfor AffirmTm reconciliation.The percent agreement between the resultsobtained by the VP MicrobialIdentification Testsand currentreference methods is lessthan the up to 15% swabto swabvariation seen in other methods.The resultsare presentedin Table4. Whenevaluated in all women,the AffirmTmTest was both sensitiveand specific as comparedto the identificationof G. vaginalisby eitherGram stain morphology or by clinicallysignificant culture levels. The relative sensitivity and specificity as comparedto Gramstain morphology AffirmTm was84% and100%, respectively. When the Test was comparedto clinicallysignificant culture levels, AffirMTM the VPIII Test hada sensitivityand specificity of 89% and99%, respectively.
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Table 4 ReconciledPerformance of the Affirm" Win Microbial Identification Test for Gardnerellavaginalis Affirm" Reference VP/ReferenceMethod Relative Relative Agreement Method Specificity I- Sensitivity (TP) FP) (FN) (TN) ForGardnerella- vaginalis, all patients(n - 299)
AffýMTM VS 171 a 33 95 84% 100% 89% Gramstain Morphotypes AffirMTM VS 170 1 21 107 89% 99% 93% Culture> 2+
For Gardnerellavaginalis, in patientswith clinicalBV by 3 of 4 Criteria(n-129) Gramstain 118 0 6 5 95% 100% 95% Morphotypes AffirmTm vs 118 0 2 9 98% 100% 98% Culture> 2 +
Trichomonasvaginalis
AffirmTm Thesensitivity and specificity of the VP MicrobialIdentification Test for Trichomonasvaginalis were established by comparisonto conventionalmicroscopy method and to culture in 852 patients. The raw performancedata for the conventionalvaginal fluid sample obtained by dacronswab is presentedin Table5.
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Table 5 UnreconciledPerformance of the AffirMTMVp Microbial Identification Test for Trichomonasvaginafis Affirm' ReferenceMethod VP/ReferenceMethod Sensitivity Specificity Agreement +1+ + I-(TP) (FP) (FN) (TN) SWABSAMPLE (n 852) Affirmvs Wet Mount 90 14 8 739 92 98 97
Affirmvs Culture, 99 5 12 735 89 99.0 98 all days
Affirmvs Culture, 97 7 9 738 92 99.0 98 < 3 days I I Wet Mountvs 91 7 20 733 82 99.0 97 Culture,all days I I
AffirMTm Affirm"m As with the Test for Candidaspecies, the apparentfalse positive samples which were positive by the Test for Trichomonasvaginalis but negative by the referencemethod were evaluated by the alternatereference method. positive" In thosecases where the "apparentfalse resultwas confirmed as positiveby the alternatereference method, the samplewas considereda true positiveand the reconciled sensitivity recalculated. The reconciled performance is presented AffirmTm in Table 6. The relativesensitivity and specificity of the VNi MicrobialIdentification Test for Trichomonas vaginalisis 93% and99.9%, respectively,as comparedto wet mountidentification of T vaginalis.Compared to a 5 to AffirmTm 7 day Diamond'sculture, the relativesensitivity and specificityof the Test are 90% and 99.9%respectively. Sincemuch of the Diamond'sculture available is for a 48 to 72 hourincubation, the sensitivityand specificitywas AffirmTm calculatedusing this as the referencestandard also. Therelative sensitivity and specificity of the Viii Microbial IdentificationTest as comparedto 48 to 72 hourDiamond's culture identification of Trichomonasvaginalis was 92% and AffirmTm 99.9%,respectively. In this clinicalevaluation, the VPIIIMicrobial Identification Test was comparablein sensitivity to 5-7 day cultureisolation of Trichomonasvaginalis.
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Table6 Affirm"m ReconciledPerformance of the VPin I Microbial Identification Test for Trichomonasvaginalis
Reference Test/Reference Method Relative Relative Agreement M et o h d Sensitivity Specificity % +1+ % % (TP) FP) (FN) (TN)
SWAB SAMPLE(n - 852)
AffirMTMVS Wet 103 1 8 739 93 99.9 99 Mount
AffirmT"vs 103 1 12 735 90 99.9 99
Culture,alldays
AffirmTmvs 102 1 9 738 92 99.7 99
Culture,< 3 days
Wet Mountvs 95 3 20 733 83 99.6 97
Culture,alldays I I I I I I I
VaginalWash SampleCollection
Inone laboratory, analternate specimen collection method was alsoevaluated in106 patients.Atthis site, an additional samplewas obtainedby instilling 3 ml of sterile saline into the vagina as a vaginalwash. Thesolution was retrievedand transferedintothe Sample Collection Tube. Once received atthe laborabory, 0.3ml of the vaginal wash was removedand examinedby conventionalwet mount analysis for motile trichomonad. The SampleCollection Tube containing thevaginal
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Affirm' wash samplewas centrifuged,and the supernantdecanted. The sensitivityand specificity of the Piii Microbial IdentificationTest for Trichomonasvaginalis using a vaginalwash samplewas 87% (47155)and 98% (51152)vs 5-7 day cultureisolation of T. vaginalisusing Diamond's medium. The one apparentfalse positiveby the AffirmTM Test was also positiveby wet mount,giving a reconciledsensitivity and specificity of 87% (48/55)and 100%(51151), respectively.
NOW CLINICALRESULTS
A total of 88 isolatesrepresenting 34 differentgenera of microorganismsidentified by Isenbergat al as clinicallyrelevant tract' to the genitourinary weretested in the AffirW Poi MicrobialIdentification Test as shownin Table7.
Table 7 VaginalFlora and Other OrganismsTested for Specificitywith Affirm" VPmMicrobial Identification Test Organism Number Organism Number Ackatobactersp. 1 ListeriamonoWqgenes 1 Actinomycessp. I Mobiluncusspp. 3 Bacteroidesspp. 4 Mycobacteriumsp. 1 Branhamellasp. 1 Mycoplasmahominis 1 Bifidobacteriumsp. 1 Illaisseriaspp. 2 Campylobactersp. 1 Neisseriagonorrhoeae 1 Candidaspp. 16 Peptococcussp. I Chlamydiatrachomatis 2 Peptostreptococcusspp. 3 Clostridiumspp. 2 Prevotellaspp. 2 Corynebacteriumspp. 1 Porphyromonassp. 1 Cryptococcusneoformans 1 Propionibacteriumsp. 1 Entamoebasp. 1 Pseudomonassp. 1 Enterobacteriacaae 5 Staphylococcusspp. 3 Enterococcussp. 1 Straptococcusspp. 3 Fusobacteriumsp. 1 Trichomonasvaginalis 9 Gardnerallavaginalls 10 Ureaplasmaurealyticum 1 Haemophilusducrayi 1 I/efflonellasp. I Lactobacillusspp. 3 Other 1
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Affirm' All of the organisms,except Cryptococcus neoformans and Candida species were nonreactive in the Wu Microbial 10' IdentificationTest for Candidaspecies at a concentrationof bacteriaper ml.
All of the organisms,except Mobiluncus mulieris, Bffidobacte-rium dentium, and Gardnerellavaginalis were nonreactive in 10' the AffirmýVP MicrobialIdentification Test for Gardnerellavaginalis at a concentrationof bacterialml.Mobiluncus 410' 8x1O' mulieriswas nonreactiveat a concentrationof bacterialml,and Bifidobacterium dentium was non-reactiveat bacterialml.BMW bacterium dentium is onlyvery rarely recovered from the vagina. MostBifidobacterium sp. andstrains of B. dentiumare recoveredfrom body sites other than the vaginaor urogenitaltract.
Affirm' All of the organisms,except Trichomonas vaginalis were nonreactivein the VP MicrobialIdentification Test for Trichomolmsvaginalis at a concentrationof 10' bacterialml.
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Intended Use The MicroProbe Corporation Affirm", VPu Microbial Identification Test is a DNA probe test intended for use in the detectionand identification of Candida species, GardnereUavaginalis, and Trichomonas vaginalis nucleic acid in vaginal fluid specimensfrom patientswith symptomsof vaginitis/vaginosis.
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7 Technological Characteristics Affirm.. The Win Microbial Identification Test for Candida species compares to culture, microscopic
methods, and latex aggultination test as follows:
Table 8 Method Comparisonfor Identification of Candidaspecies (yeast)
AFFIRM- WET MOUNT GRAM STAIN VagiTese CULTURE (SuperDuo I -K#892802) Sample Vaginalswab Vaginalswab Vaginalswab Vaginalswab Vaginalswab
Transport Dry tube Dry or saline None or transport Salinefilled tube Transportmedium filledtube medium
Transport/ 4hr 0-8'C or Ihr Minimal Same day None Same day Holding RT Time
Sample Add Solutions Mix vaginal Roll swab on slide, Agitateswab 10 Roll swab on Preparation and heat fluidwith 2 airdry, heat fix seconds,remove Sabouraud'splate, dropsof 10% swab streakfor KOH on slide isolations,incubate plate35-37oC for 48 hours
Test Add sample to Examine Add crystalviolet, Add sample,add Examine platesfor Procedure reagentcassette, microscopically wash, add iodine, 2 controls,add growth, Gram placePAC, forbudding wash, decolorize, solution,mix with staincolonies sample processed yeastor counterstain,wash, separatemixing automatically pseudohyphae blotdry. Examine sticks.Examine microscopicallyfor visuallyfor peudohyphaefbudding agglutination. yeast
Principle DNA Morphology Color,morphology Antibody-antigen Growth on selective hybridization agglutination media,gram stain reaction result
Test Results Candida species Yeast Yeast Yeast Yeast - Test Time 40 min 5 10 min 5 - 10 min 2 min 48 hours - Read Time Immediate I 5 min I - 5 min 1-5min 5 - 10 min I I I
Quantitation Qualitative Qualitative Qualitative Qualitative Qualitativeor Semi-quantitative
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Gardnerella vaginalis
The Affirm' VP Microbial Identification Test for the identification of Gardnerella vaginalis is comparable to the use of culture and Gram stain for G. vaginalis. Table 9 summarizes the similarities and differences of these 3 methods.
Table 9 Method Comparison for Identification of Gardnerella vaginalis
AFFERM- GRAM STAIN I CULTURE
Sample Vaginalswab Vaginalswab Vaginalswab
Transport Dry tube Transportmedium Transportmedium TransportTime 4hr0-8'C or IhrRT Same day Same day SamplePreparation Add Solutionsand Rollswab on slide, Rollswab on plate,streak heat airdry, heat fix withloop, incubate plate TestProcedure Add Solution,add Add crystal Examineplates sample,place PAC, violet,wash,add Gram stain sampleprocessed iodine,wash, Testfor production of automatically decolorize, catalase counterstain,wash, blotdry Principle DNA hybridization Color,morphology Growth,colony appearance, Gram stain+ Catalase test
Results Speciesspecific, Gardnerella Species-Testspecific identifiesGardnerella vaginalLv or vaginalis Bacteroidesspp TestTime 40 min 5 10 min 24 -72 hours Read Time Immediate 1 5 min 5 - 10 min
Quantitation Qualitative Serni-quantitative Qualitative or I quantitative semi-I
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Trichomonasvaginalis
The Affin-n- VP Microbial Identification Test for the identification of Tfichomonasvaginalis is comparableto the use of saline wet mount and culture for T. vaginaUs. Table 10 summarizesthe similaritiesand differencesof these3 methods.
Table 10 Method Comparisonfor Identification of Ttichomonasvaginalis
mwflm- CULTURE I WET MOUNT I Sample Vaginalswab Vaginalswab Vaginalswab
Transport Dry tube Dry or salinefilled Isolation Med tube
TransportTime 4hr 0-8'C or lhr Minimal Same day RT Sample Add Solutionsand Mix vaginalfluid Place swab in Preparation heat with2 dropsof Diamond'sMedium 0.85 % NaCl on slide TestProcedure Add Solution,add Examinemicro- Incubatefor up to7 sample,place PAC, scopicallyfor motile days,prepare wet sampleprocessed trichomonads mountsdaily and automatically examine microscopicallyfor motiletrichomonads Principle DNA hybridization Characteristicmotility Characteristic and morphology;host motilityand specificityof morphology;host trichomonads specificityof trichomonads TestResults Speciesspecific, Speciesspecific, Speciesspecific, identifies identifies identifies Trichomonas THchomonas Trichomonas vaginalis vaginalis vaginalis TestTime 40 min 5 - 10 min Up to 7 days Read Time Immediate 5 - 10 min 5 - 10 min
Quantitation Qualitative Qualitative Qualitative
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DO NOT REMOVE THIS ROUTE SLIP!!!!
K-93-1374 4/2/93
FROM: ILETTER DATE ILOGIN DATE IDUE DATE MICROPROBE CORP. 1 03/16/93 1 03/18/93 1 06/16/93 ATTN: RUSSEL K. ENNS I------I 220TH ST. S.E., #104 ITYPE OF DOCUMEN, ICONTROL------1725 # I 1 510 I K931374 I ------(k) ------BOTHELL, WA 98021 1 I I PHONE NO: 800-447- 3 SHORT NAME: MICROPROBE ESTABLISHMENT NO: ------_t_w_ TO: ICONT. CONF.: ODE/DMC ISTATUS : R I IREV PANEL : MI I JPAN/PROD CODE(S): MI/
------SUBJECT:JUN AFFIRM VPIII MICROBIAL IDENTIFICATION TEST MILA 15 1993 ------ DECISION: RQST INFO DATE: JINFO DUE DATE: DECISION DATE: DATE: DATE: DATE: DATE: DATE: DATE: DATE: DATE: DATE: DATE: ------ 7 3 3 ------19 ot 1-r-9 ý'l'x"
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
!sk Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration 1390 PiccardDrive JUN15. 1993 Rockville,MD 20850
Russel K. Enns, Ph.D. Re: K931374 Director of Technical Affairs Product: Affirm VPIII Microbial Mi6roprobe Corp. Identification Test 1725 220th Street, S.W., Suite 104 Dated: March 16, 1993 Bothell, WA 98021 Received: March 18, 1993 Regulatory Class: I
Dear Dr. Enns:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Fed-gral RecistOr. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control. for Health and safety Act of 1968, or other Federal Laws or regulations.
This letter immediately will allow you top begin marketing your device as described. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA apT)roves your device. Therefore, you may not promote or in any way represent your device or its labeling as being alpyroved by FDA. If you desire specific advice on the labeling for your device, please contact the Division of Compliance operations, Device Labeling Compliance Branch (HFZ-326) at (301) 427-1342. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800-) 638-2041 or at (301) 443-6597.
Sincerely yours, A Steven I. Gutman, M.D., M.B.A. Acting Director Division of Clinical Laboratory Devices office of Device Evaluation Center for Devices and Radiological Health
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 14 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Memorandum
bate
From REVIEWER(S) - NAME(S)
Subject 510(k) NOTIFICATION
To THE RECORD
It is my recommendation that the subject 510(k) Notification:
&eo""(A) Is substantially equivalent to marketed devices.
(B) Requires premarket approval. NOT substantially equivalent to marketed devices.
- (C) Requires more data.
(D) Other (e.g., exempt by regulation, not a device, duplicate, etc.) 6-40 dra..'0d::%0d06 Additional Comments: '4pf &ýXO?Pýov* do,, ,o47tC%#V 0 0p;V >e. Zýp4ove, Is this device subject to Postmarket Surveillance? Yes No El 9 This 510(k) contains: (check appropriate box(es))
A 510(k) summary of safety and effectiveness, or [A E] A 510(k) statement that safety and effectiveness information will be made available
The required certification and summary for class III devices
The submitter requests under Predicate Product Code w/panel 21 CFR 807.95:* and class: low0'of" .09 No A1 Confidentiality V'0-107' IV7 Confidentiality for 90 days Additional Product Code(s) w/Panel (optional): Continued Confidentiality elceeding 90 days DA,0A2 P.-YA REVIEW0T(/(""J5 Jý" o"
FINAL-REVIEW. 0.3 ('D&TE)* (DIVISION DIRECTOR) I
"SE" 111`18"- W Questions?*DOES ContactNOT APPLY FDA/CDRH/OCE/DID TO ANY DECISIONS at [email protected] orRevised 301-796-8118 0ý-- .
Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
EQUIVALENCE' 510(k) "SUBSTANTIAL DECISION-MAKING PROCESS(DEWLED)
NewDevice Is Compa" to MeAded bcvim*
No Doth the intended Yes DomNew Havesame TherapadWAXacmaddetc. Indicationstat Effed oa Dadda& may Equivalent' atialty Considerbnpad anSardy and Yes Effective,,,).!.. Determination NO
Descriptivehdormation NewDevilee Um SometMaWed NewDevim Has New aboutNeiv or ?I-rkdd Usea" Mmybe *Subdan"y rMteadeduse DeviceRequested F asNeeded
Ncq New Do CharactecistIcs Does WeItave Same No Couldthe yes the New yes T-b-1091-1 CbItSetcristics,ý Characteristics RaiseNew Types of Safetyor -g., Destga.red . ctc.? AffectSafety Effectiveness, or Effectiveness? __Tes No No (D,.p @ I No Are Ive Do Accepted 'wific Methods ChanctoWla Fredu Enough ExistforAnessing Effects of to tam" 144 the New(3utracteristics? No Yes"s Yes re NO ArePerfocmance Data Avallable DataAvailable No to AssessF-4ulvsl,,c,?.. to AssessEffects of New
Characteristics?-Yes Yes I Polot="Ce Perforinaacc Data Daft P.equired Required
L PerformanceData Demoustratlirg map" DataDemonstrate Equivalence? es Yes EqWM%kxtcc? No No
'SubstantiallyEquivalent* Determination TO
510(k) subnýisslons,oonxWocýuew devices to marketed devicm FDA requests additional WWMad0nurtdcad.' if th_F rC i ati to n5hi p bdvmq marketed and *Oridi;aW (pce-Aýnendn'wts or reclassifiedpost-Amendments) devices is
W4 decidon is normaHy based on descriptive information alone, but limited testing informatioft is sometimes required.
Data maybe id,the.510(k), other 510(k)s. the Centees classificatitonGIM at the literature.
M" Questions?% Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 Page - I
Y, 93 A-3.7 -SUBSTANTIAL EQUIVALENCE- (Sh) DECISION MAKING DOCUMENTATION
1441' REVIEWER.JifiN44, CY 1Ce DIVIS1014/BRANCH-1 V10 40t45 7L TRADE NAME: AZ%W20. COMMON N o. PRODUCT TO WHICH COMPARED: (510(k) NUMBER IF KNOWN)
YES CNO) I
1. IS PRODUCT A DEVICE? IF NO STOP
2. DEVICE SU&JECT TO 510(k)? IF NO STOP
3. SAME INDICATION STATEMENT? IF YES GO TO 5
DODIFFERENCES ALTER THE EFFECT OR RAISE NEW ISSUES OF RAFETY OR EFFEC.TIVENESS?. -IF-YES STOP
5."' SAME TECHNOLOGICAL CHARACTERISTICS? IF YES GO TO 7
COULD,THE NEW CHARACTEýýISTICS-AFFECT-. 8' G SAFETY OR EFFECTIVENE9S? IF YES GO TO
7. DESCRIPTIVE CHARACTERISTICS PRECISE IF NO GO 10A ENOUGH? IF YES SA OA -/SE\r
NEW TYPES OF SAFETY OR EFFECTIVENESS QUESTIONS? IF YES STOP
9. ACCEPTED SCIENTIFIC METHODS'EXIST? IF NO STOP
10. PERFORMANCE DATA AVAILABLE? IF NO REQUEST DATA
DATA DEMONSTRATE EQUIVALENCE?.
A "YESn NOTE: IN ADDITION TO COMPLETING PAGE TWO, RESPONSES TO QUESTIONS 4', 6, 8, AND 11, AND EVERY -NO- RESPONSE REQUIRES AN EXPLANATION ON PA0,ETHREE.AND/OR FOUR
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
EQUIVALENCE" SUBSTANTIAL (SE) DECISION-MAKING DOCUMENTATION 1. INTENDED USE:
The MicroProbe Corporation Affirm VP Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis/ vaginosis.
2. DEVICE DESCRIPTION:
This device is an in vitro laboratory test kit which contains the reagents, controls and materials necessary to identify Candida species, G. vaginalis and T. vaginalis directly from a patient specimen by detecting the presence of Candida species, g. vaginalis and T. vaginalis nucleic acids based on the principles of nucleic acid hybridization. This device is to be used with the Affirm VP Sample Processor, K923268, found SE July 30, 1992 and the Affirm VP Sample Collection Set, K920536, found SE July 30, 1992. (see attachment #1 for a more specific description of the scientific/technological principles of the device).
Each probe analysis card (PAC) in addition to the three specific beads for each organism, contains a positive or procedure control as well as a negative or specificity control so that the user will know that the PAC card and the reagents are working properly. Additional procedures for Q.C. by the user are described in the package insert. This device when used with the Affirm Processor is able to give an objective and specific test results by the use of automation in 40 minutes while current methods to detect G. vaginalis, T. vaginalis and Candida species by culture can take up to 5 days and the visualization of Candida species, -G, vaginalis and T. vaginalis on wet mount/and or Gram stain is subjective and requires interpretation by a skilled reader.
Please note that Microprobe has previously submitted separate 510(k)s for the microorganisms detected by this device. This submission was to change the format of the device so that the probe analysis card contains reaction beads for all three microorganisms.
K922475 T. vaginalis
K923133 T. vaginalis and G. vaginalis
K931151 Candida species
Because Microprobe had previously submitted performance data wjvtfieach 510(k) submission, the descriptive characteristics are precise enough to determine equivalence. See attached copies of the SE'documentation for K923133 and K931151 I
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
4 Device Description:
4.1 Explanation of the Test
The MicroProbe Affirm' VPm Microbial Identification Test is basedon the principles of nucleic acid hybridization. Nucleic acid hybridization tests, also known as DNA probe tests, are based double- on the ability of complementarynucleic. acid strandsto align and form specific, stranded complexescalled hybrids.
The Affirm.. VPm Microbial Identification Test use two, single-strandednucleic acid probes, a capture and a color-developmentprobe, that are complementaryto unique genetic sequences of eachof the target organisms. The captureprobe for eachorganism is immobilizedon a bead that is embedded in a card referred to as a Probe Analysis Card (PAC). The color-development probe is in a multi-weU reagent cassettethat contains the test reagents.
The procedureis outlined in three steps: 1) Samplepreparation of the target organism nucleic acid; 2) automatedassay processing; and 3) test results reading. During samplepreparation, the sample is treated with Lysis Solution and then heated. This process rupturesthe walls of the organisms releasing the nucleic acid. A second solution, the Buffer Solution, is added; this solution stabilizes the nucleic acid and establishes the conditions necessaryfor specific hybridization. The sample is then addedto the first well of the ReagentCassette, and automated processing begins. The Affirm- Sample Processor moves the PAC from one well of the ReagentCassette to another. Hybridization of the target nucleic acid to the DNA probe on the target specificbead occurs in well 1, and the hybridization of the color-developmentDNA probe occurs in well 2. All unbound sample components are washed away in well 3. Enzyme conjugatebinds to the captured color developmentprobe in well 4. Unbound conjugateand probes are washedaway in wells 5 and 6. In well 7 the enzyme substrateis converted to a blue-colored product if bound enzyme conjugate is present on the beads. The final step is reading the color developmenton the beads.
5
& Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
EQUIVALENCE" SUBSTANTIAL (SE) DECISION-MAKING DOCUMENTATION
INTENDED USE: The MicroProbe Corporation Affirm VP Microbial Identification Test is a DNA probe test intended for use in the detection of nucleic acid from Candida species in vaginal fluid from patients with symptoms of vaginitis.
2. DEVICE DESCRIPTION: This device is an in vitro laboratory test kit which contains the reagents, controls and materials necessary to identify Candida species directly from a patient specimen by detecting the presence of Candida species nucleic acids based on the principles of nucleic acid hybridization. This device is to be used with the Affirm VP Sample Processor, K923268, found SE July 30, 1992 and the Affirm VP Sample Collection Set, K920536, found SE July 30, 1992. (see attachment #1 for a more specific description of the scientific/technological principles of the device). Each probe analysis card (PAC) contains a positive or procedure control as well as a negative or specificity control so that the user will know that the PAC card and the reagents are working properly. Additional procedures for Q.C. are described in the package insert.
This device when used with the Affirm Processor is able to give an objective and specific test result by the use of automation in 40 minutes while current methods to detect Candida species by culture can take up to 48 hours and the visualization of Candida species on wet mount is subjective and requires interpretation by a skilled reader.
5. IF THE ANSWER TO QUESTION 5 IS NO, DESCRIBE THE NEW TECHNOLOGICAL CHARACTERISTICS. This device is the first device to detect and identify Candida species based on detection of Candida species nucleic acids directly from a patient specimen. Previous methods to detect Candida species were based on the visualization of the microorganism by the use of a wet mount or by culturing the organism.
6. IF THE ANSWER TO QUESTION 6 IS YES OR NO, EXPLAIN HOW THE NEW CHARACTERISTICS COULD/COULD NOT AFFECT SAFETY OR EFFECTIVENESS. A change in technology from one based on culture or visualization of the organism to one based on the detection of specific nucleic acid sequences could effect the safety and effect iveii-5-5 rlJ th(-7ý ir-f-to detect Candida species.
_&ý -.A- Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
IF THE ANSWER TO QUESTION 8 IS YES OR NO, EXPLAIN THE NEW TYPES OF SAFETY OR EFFECTIVENESS QUESTIONS RAISED OR WHY THE QUESTIONS ARE NOT NEW.
Since this device is an in vitro laboratory device, the issues of safety and effectiveness are sensitivity and specificity which are the same issues for all in vitro devices.
While this is the first device utilizing DNA probe technology for Candida species, other devices based on this technology that detect other microorganisms directly from a patient specimen have been found SE.
11. IF THE ANSWER TO QUESTION 11 IS YES OR NO, EXPLAIN HOW THE PERFORMANCE DATA DEMONSTRATES THAT THE DEVICE IS/IS NOT SUBSTANTIALLY EQUIVALENT. The performance data demonstrated that the device was substantially equivalent. A total of 740 patients, 479 who were symptomatic for vaginitis/vaginosis and 261 who were not symptomatic for vaginitis/ vaginosis but were at a clinic for some other reason (STD contact, family planning or pregnancy), from 5 different clinical sites were evaluated for the presence of Candida species by four methods: wet mount, gram stain, culture, and this device. There was a difference in the performance of the device based on whether the patients entered the clinic with symptoms. See attached tables 2 and 3 for a summary of the unreconciled performance and reconciled performance of the device.
A total of 88 isolates representing 34 different genera of microorganisms were tested in the Affirm VP Microbial Identification Test for Candida species. All of the organisms tested except Candida species and Cryptococcus neoformans were non reactive in the Affirm Assay for Cand-i-d-aspecies.
0008 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Table 1 Unreconciled Performance of the AffirMTM VPw Microbial Identification Test, Wet Mount Analysis,and Gram stain to CultureIdentification of Candida species
TestiCulture +1+ Sensitivity Specificity Accuracy
(TP) (FP) (FN) (TN) N N N
All patients(n=740)
AffirmTm 85 26 24 605 78.0 95.9 93.2
Wet Mount 59 52 50 579 54.1 91.8 86.2
-9 Stain(n-484) 25 6 35 418 41.7 98.6 91.5
bi patients with presentingsymptoms of Vaginitis(n=479) firmTm Af 65 20 17 377 79.3 95.0 92.3
Wet Mount 55 44 27 353 67.1 88.9 85.2
GramStain (n-329) [23 4 31 271 42.6 98.5 89.4
for patientswithout presentingsymptoms of Vaginitis(n=261)
Affire 20 6 7 228 74.1 97.4 95.0
Wet Mount 4 8 23 226 14.8 96.6 88.1
GramStain (N - 155) 2 2 4 147 33.3 98.7 96.1
10
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Table 2 AffirMT1 Reconciled Performance of the VPIII Microbial Identification Test, Wet
Mount Analysis, and Gram stain to Culture Identification of Candida species
TestlCulture +1+ +1. -1+ 1- Sensitivity Specificity Accuracy (TP) (FP) (FN) (TN) N N N
All patients(n=740)
AffirmTM 100 Ila 24 605 80.6 98.2 95.3
e t Mount W e'et M 0 Mount W 74 37b 50 579 59.7 94.0 88.2
Gr ram Stain (n-484) 28 3 35 418 44.4 92.1
r pal Forpatientswith presentingsymptoms of Vaginitis(n=479)
AffirmTM 79 6 17 377 82.3 98.4 95.2
ýrdt Mount 69 30 27 353 71.9 92.2 88.1
GramStain (n - 329) 26 1 31 271 45.6 99.6 90.2
For patientswithout presentingsymptoms of Vaginitis(N=261)
AffirmTM 21 5 7 228 75.0 97.9 95.4
WetMount 5 7 23 226 17.9 97.0 88.5
GramStain (N - 155) 2 2 4 147 33.3 98.7 96.1
Affirm' 10 of 11 sampleswere positive by culture, but at levels lessthan 104 yeast per mi. The eleventhsample was positive by a duplicate WE Test. 11-of 37 sampleswere positive by culture, but at levels < 103 yeast perml. Of the remaining26, 1 was positiveby a duplicateAffirmTM Test, 15 of 15 were negative an a duplicate smear made from the sameswab as the wet mount. Non-Clinical Results
A total of 88 isolatesrepresenting 34 differentgenera of microorganismsidentified by Isenberget alas clinically tract' Affirm"' relevantto the genitourinary weretested in the VPniMicrobial Identification Test for Candida speciesas is shown in Table3. Allof the organisms, except Cryptococcus neoformans, were nonreactive inthe
11
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118AA0 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 3 / '3'ý3
EQUIVALENCE" SUBSTANTIAL (SE) DECISION-MAKING DOCUMENTATION
1. INTENDED USE:
The MicroProbe Corporation Affirm VP Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis/ vaginosis.
Please note that a separate 510(K) submission K922457 was submitted by Microprobe to detect T vaginalis.
2. DEVICE DESCRIPTION:
This device is an in vitro laboratory test kit which contains the reagents, controls and materials necessary to identify both G. vaginalis and T. vaginalis directly from a patient specimen Ey detecting the presence of G. vaginalis and T. vaginalis nucleic acids based on the principles of nucleic acid hybridization. This device is to be used with the Affirm VP Sample Processor, K923268, found SE July 30, 1992 and the Affirm VP Sample Collection Set, K920536, found SE July 30, 1992. (see attachment #1 for a more specific description of the scientific/technological principles of the device). Each probe analysis card (PAC) in addition to the two specific beads for each organism, contains a positive or procedure control as well as a negative or specificity control so that the user will know that the PAC card and the reagents are working properly. Additional procedures for Q.C. by the user are described in the package insert.
This device when used with the Affirm Processor is able to give an objective and specific test result by the use of automation in 40 minutes while current methods to detect both G vaginalis and T. vaginalis by culture can take up to 5 days and the visualization of G. vaginalis and T. vaginalis on wet mount/and or Gram stain is subjective and requires interpretation by a skilled reader.
5. IF THE ANSWER TO QUESTION 5 IS NO, DESCRIBE THE NEW TECHNOLOGICAL CHARACTERISTICS. This device is the first device to detect and identify G. vaginalis based on detection of G. vaginalis nucleic acid directly from a patient specimen. Previous methods to detect G. vaginalis were based on the visualization of the microorganism by tfý_euse of a-wet mount/and or Gram Stain or by culturing the oxýýariism.
IF THE ANSWER TO QUESTION 6 IS YES OR NO, EXPLAIN HOW THE NFý'] CHARACTERISTICS COULD/COULD NOT AFFECT SAFETY OR EFFECTIVENES,,. A change in technology from one based on culture or visualizal,-A.c-mc)ý[ the organism to one based on the detection of specific nud' leic acid sequences could effect the safety and effectiveness of the device to detect G. vaginalis.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
8. IF THE ANSWER TO QUESTION 8 IS YES OR NO, EXPLAIN THE NEW TYPES OF SAFETY OR EFFECTIVENESS QUESTIONS RAISED OR WHY THE QUESTIONS ARE NOT NEW.
Since this device is an in vitro laboratory device, the issues of safety and effectiveness are sensitivity and specificity which are the same issues for all in vitro devices.
While this is the first device utilizing DNA probe technology for G. vaginalis, other devices based on this technology that detect other microorganisms directly from a patient specimen have been found SE.
11. IF THE ANSWER TO QUESTION 11 IS YES OR NO, EXPLAIN HOW THE PERFORMANCE DATA DEMONSTRATES THAT THE DEVICE IS/IS NOT SUBSTANTIALLY EQUIVALENT.
The performance data demonstrated that the device was substantially equivalent. A total of 299 patients who were symptomatic for vaginitis/ vaginosis from 4 different clinical sites were evaluated for the presence of G. vaginalis by three methods gram stain, culture, and this device. Gramý-Stain detected 123 of the 129(95%) patients that were clinically diagnosed with bacterial vaginosis (BV), Affirm detected 118 of the 129(91%), culture detected 107 of the 129 (83%). In the 170 patients without clinically diagnosed BV. the gram stain was positive in 77 (45%), the culture was positive in 61 (36%) and this device was positive in 61(36%) patients.
In addition to the clinical performance data described above, a total of 109 isolates representing 88 different species of microorganisms were tested in the Affirm VP Microbial Identification Test for G. vaginalis. All of the organisms tested except G. vaginalis, Mobiluncus mulieris, and Bifidobacterium dentium were non reactive in the Affirm Assay for Gardnerella vaginalis. Mobiluncus mulieris is a bacteria also associated with BV, while B. dentium is rarely isolated from a vaginal source.
See attached copies of the SE documentation for K922457 for the substantial equivalence data for Trichomonas vaginalis.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
=4 'i Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
EQUIVALENCE" SUBSTANTIAL (SE) DECISION-MAKING DOCUMENTATION
INTENDED USE: The MicroProbe Corporation Affirm VP Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis/ vaginosis.
2. DEVICE DESCRIPTION: This device is an in vitro laboratory test kit which contains the reagents, controls and materials necessary to identify T. vaginalis directly from a patient specimen by detecting the presence of T. vaginalis nucleic acids based on the principles of nucleic acid hybridization. This device is to be used with the Affirm VP Sample Processor, K923268, found SE July 30, 1992 and the Affirm VP Sample Collection Set, K920536, found SE July 30, 1992. (see attachment #1 for a more specific description of the scientific/technological principles of the device). Each probe analysis card (PAC) contains a positive or procedure control as well as a negative or specificity control so that the user will know that the PAC card and the reagents are working properly. Additional procedures for Q.C. are described in the package insert.
This device when used with the Affirm Processor is able to give an objective and specific test result by the use of automation in 40 minutes while current methods to detect T. vaginalis by culture can take up to 5 days and the visualization Z;-fT. vaginalis on wet mount is subjective and requires interpretation by a skilled reader.
5. IF THE ANSWER TO QUESTION 5 IS NO, DESCRIBE THE NEW TECHNOLOGICAL CHARACTERISTICS. This device is the first device to detect and identify T. vaginalis based on detection of T. vaginalis nucleic acid directly from a patient specimen. Previous methods to detect T vaginalis were based on the visualization of the microorganism by the use of a wet mount or by culturing the organism.
6. IF THE ANSWER TO QUESTION 6 IS YES OR NO, EXPLAIN HOW THE NEW CHARACTERISTICS COULD/COULD NOT AFFECT SAFETY OR EFFECTIVENESS. A change in technology from one based on culture or visualization of the organism to one based on the detection of specifi.c-nucle-i,- acid sequences could effect the safety and effectiveness of the (](--ýviceto detect T. vaginalis.
8. IF THE ANSWER TO QUESTION 8 IS YES OR NO, EXPLAIN THE NEW TYPES'OF SAFETY OR EFFECTIVENESS QUESTIONS RAISED OR WHY THE QUESTIONS ARE NOT NEW.
Since this device is an in vitro laboratory device, the issues of Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 4 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
safety and effectiveness are sensitivity and specificity which are the same issues for all in vitro devices.
While this is the first device utilizing DNA probe technology for T. vaginalis, other devices based on this technology that detect other microorganisms directly from a patient specimen have been found SE.
11. IF THE ANSWER TO QUESTION 11 IS YES OR NO, EXPLAIN HOW THE PERFORMANCE DATA DEMONSTRATES THAT THE DEVICE IS/IS NOT SUBSTANTIALLY EQUIVALENT. The performance data demonstrated that the device was substantially equivalent. A total of 593 patients who were symptomatic for vaginitis/ vaginosis from 5 different clinical sites were evaluated for the presence of T vaginalis by three methods wet mount, culture and this device. Wet mount detected 79/593 (13.3%), Affirm detected 86/593 (14.5%), culture detected 96/593 (16.2%). When compared to wet mount, the relative sensitivity was 86% and the relative specificity was 97%. When compared to culture, the relative sensitivity was 82% and the relative specificity was 99%.
A total of 109 isolates representing 88 different species of microorganisms were tested in the Affirm VP Microbial Identification Test for T. vaginalis. All of the organisms tested except T. vaginalis were non 'Ee-active in the Affirm Assay for T. vginalis.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
GM4 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service
Food and Drug Administration Center for Devices and Radiological Health Office Of Device Evaluation Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, Maryland 20850
APRIL 2, 1993
MICROPROBE CORP. 510(k) Number: K931374 ATTN: RUSSEL K. ENNS Received: 03-18-93 1725 220TH ST. S.E., #104 Product: AFFIRM VPIII BOTHELL, WA 98021 MICROBIAL IDENTIFICATIONTEST
We have received the Premarket Notificationyou submitted in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act (Act) for the above referenced product. We have assigned your submission a unique 510(k) number that is cited above. Please refer prominently to this 510(k) number in any future correspondencethat relates to this submission. We will notify you when the processing of your premarket notificationhas been completed or if any additional information is required.
The Safe Medical Devices Act of 1990 (SMDA),signed on November 28, states that you may not place this device into commercial distributionuntil you receive a letter from FDA allowing you to do so. As in the past, we intend to complete our review as quickly as possible. Generally we do so within 90 days. However, the complexity of a submission or a requirement for additional informationmay occasionallycause the review to extend beyond 90 days. Thus, if you have not received a written decision or been contacted within 90 days of our receipt date, you may want to check with FDA to determine the status of your submission.
In addition, the SMDA requires all persons submittinga premarket notificationsubmission to include either (1) a summary of the safety and effectiveness information in the premarket notificationsubmission upon which an equivalence determinationcould be based (510(k) summary), OR (2) a statement that safety and effectivenessinformation will be made available to interested persons upon request (510(k) statement). Safety and effectivenessinformation refers to information in the premarket notification submission, including adverse safety and effectivenessinformation, that is relevant to an assessment of substantialequivalence. The information could be descriptive informationabout the new and predicate device(s), or performance or clinical testing information. We cannot issue a final decision on your 510(k) unless you comply with this requirement.
Although FDA acknowledgesthat the law provides the 510(k) submitter an alternative,FDA encouragesmanufacturers to provide a 510(k) statement to FDA and to make their safety and effectivenessinformation available to the public, excluding confidentialmanufacturing process information,in lieu of submitting a 510(k) summary to the agency until FDA promulgates a regulation on the content and format of 510(k) summaries. Since the law
0 *
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requires that FDA must make the 510(k) summary, or the source of information referred to in the 510(k) statement,publicly available vithin 30 days of making a substantial equivalence determination,ve advise you that we way no longer honor any request for extended confidentialityunder 21 CFR 807.95.
Additionally,the new legislation also requires any person who asserts that a device is substantiallyequivalent to a class III device to (1) certify that he or she has conducted a reasonable search of all informationknown, or otherwise available, about the generic type of device, AND (2) provide a summary descriptionof the types of safety and effectivenessproblems associated with the type of device and a citation to the literature,or other sources of information,upon which they have based the description (class III summary and certification). The description should be sufficientlycomprehensive to demonstrate that an applicant is fully aware of the types of problems to which the device is susceptible. If you have not provided this class III summary and certificationin your premarket notification,please provide it as soon as possible. We cannot complete the review of your submission until you do so.
Furthermore,the new legislation,section 522(a)(1), of the Act, states that if your device is a permanent implant the failure of which may cause death, you may be subject to required postmarket surveillance. If the premarket notification for your device was originally received on or after November 8, 1991, is subsequentlyfound to be substantiallyequivalent to an Aneurysm Clip, AnnuloplastyRing, Artificial EmbolizationDevice, Automatic Implanted CardioverterDefibrillator System, Cardiovascular IntravascularFilter, CardiovascularPermanent Pacemaker Electrode (Lead), Central Nervous System Fluid Shunt, Coronary Vascular Stent, Implantable Pacemaker Pulse Generator, ImplantedDiaphragmatic/Phrenic Nerve Stimulator,Intracardiac Patch or Pledget, IntravascularOccluding Catheter,Replacement Heart Valve, Total Artificial Heart, Tracheal Prosthesis,Vascular Graft Prosthesis (less than 6 mm diameter), Vascular Graft Prosthesis (6 mm or greater diameter), Vena Cava Clip, or Ventricular Assist Device - Implant, you will be subject to the required postmarket surveillanceand so notified of this determinationin your substantially equivalent letter. (Some of the above listed types of devices may require a premarket approval application). This list is subject to change without notification. If you have any questions as to whether or not your device may be subject to postmarket surveillanceor about this program, please contact the Postmarket SurveillanceStudies Branch at (301) 227-8006.
Please note that the SMDA may have additional requirementsaffecting your device. You will be informed of these requirementsas they become effective.
Please remember that all correspondenceconcerning your submission MUST be sent to the Document Mail Center (HFZ-401)at the above letterhead address. Correspondencesent to any address other than the Document Mail Center will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitationswe cannot accept telefaxed material as part of your official premarket notification submission, unless specificallyrequested of you by an FDA official.
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If you have procedural or policy questions, please contact the Division of Small ManufacturersAssistance at (301) 443-6597 or their toll-free number (800) 638-2041, or contact me at (301) 427-1190.
Sincerelyyours,
Marjorie Shulman SupervisoryConsumer Safety Officer Premarket Notification Section Office of Device Evaluation Center for Devices and RadiologicalHealth
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released byýý CDRHq oný) 11-22-20161577,1 MICROPROBE C 0 R P 0 R A T 1 0 N
March 16,1993
Food and Drug Administration Centerfor Devices and RadiologicalHealth 4ý0 Officeof Device Evaluations Document Mail Center(I-IFZ-401) 1390 PiccardDrive Rockville,MD 20850
RE: Amended 510(k)Premarket Notification, k923133 AFFIRMTm ProductName: VP MICROBIAL IDENTIFICATION TEST FOR GARDNERELLA VAGINIALIS, AND TRICHOMONAS VAGINA LIS
CLIA QC REVIEW REQUESTED Attention:Document Mail Clerk:
MicroProbeCorporation is requesting an amendment to its5 1 0(k) premarket notification of the AFFIRM' VP MICROBIAL IDENTIFICATION TEST FOR GA RDNERELLA VA GINIA LIS AND TRICHOMONAS VAGINALIS, K923133, MicroProbewants to amend itsclaim for this productto includethe detection of Candidaspecies, and changethe name of theproduct to the AFFIRM' VPiii MICROBIAL IDENTIFICATION TEST FOR CANDIDA SPECIES, GARDNERELLA VAGINA LIS,AND TRICHOMONA S VAGINA LIS. The performanceclaims forthe detectionof Candidaspecies was recentlyfiled as a new 510(k)premarket notification for the Affirm' VPiiiIdentification Test for Candida specieson March 5, 1993. Also, MicroProbeCorporation requests that the performanceclaims for Tfichornonasvaginalis be upgradedwith the results from new clinicaltrials performed in the lastyear.
As demonstratedin the attached document, this in vitro diagnostic kit is substantially equivalent to standardmethods used in theUnited States for detectingand identifyingCcwdida species, Gardnerellavaginalis, and Tfichomonasvaginalis. Also, this kit uses the same technologyand principlesasthe previously cleared MicroProbe products for Trichomonas vaginalis (K922457/A) and Trichomonasvaginalis and Gardnerellavaginalis (K923133), as well as the recently Affirm' submittedpremarket notification for VPui MicrobialIdentification Test for Candida Affirm' species.As withthe two clearedproducts, the Test forCandida species, previously Affirm' Gardnerellavaginiahs, and Tfichomonasvaginalis uses the same VP SampleCollection Affirm' Kit (K920536/A)and the same automated SampleProcessor (K923268).
MicroProbeCorporation chooses to submit a 5 10(k) summary ofthis submission as pretented in the FederalRegister of April28, 1992,21 CFR Part807: MedicalDevices, Substantial Equivalence,51 0(k) Summaries and 51 0(k) Statements, Class III Summaries, Confidentiala 0 Information.
CorporateHeadquarters CaliforniaOperations 0M '7390Lincoln (714)894-7184 1725220thQuestions? Street S.E., Contact 104 FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 BothellWA 98021 (206)485-8566 GardenGrove, CA 92641 FAX:(714) 891-1229 (800)447-4362 FAX:(206) 486-8336 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Affirm"' Also, MicroProbe Corporation requests CLIA QC Review of the VPM Microbial Identification Test for Candida species,Gardnerella vaginalis, and Dichomonasvaginalis accordingto the draft FDA guidanceannounced in the FederalRegister Notice of January12, 1993. MicroProbeCorporation requests that this testbe classifiedas a devicewith "moderate complexity" accordingto the CLIA '88 regulationspublished in the FederalResgister, February 28, 1992.
If you shouldrequire additional information, please contact me at (206) 485-8566. If I am unavailable,please feet free to ask for Dr. Michael Gendreau,Vice Presidentof Diagnostics R&D.
Sincerely,
RusselK. Enns, Ph.D. Directorof TechnicalAffairs
000 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
510 (k) Premarket Notification NficroProbe Corporation
Contents
Section
I 510(k) Summary
510(k) PremarketNotification 11
ProposedLabeling III
CLIA QC Review Requested IV
References V
Line Listing of Patient Data VI
1
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
SECTION I Affwm' VPw Nficrobial Identification Test for Candidaspecies, Gardnerella vaginalis, and Dichomonasvaginalis
2
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510(k) Summary Afrwm7 Win Microbial Identification Test for Candidaspecies, Gardnerella vaginalis, and Trichomonasvaginalis
I Establishment: MicroProbeCorporation 1725 220th StreetS.E., #104 Bothell, WA 98021 (206) 485-8566 Contact: RusselK. Enns, Ph.D. Director, TechnicalAffairs Prepared: March 16, 1993
2 Trade Name: Affirm- VPm Microbial IdentificationTest for Candida species, Gardnerellavaginalis, and Trichomonas vaginalls
CommonName: DNA ProbeTest for detectionof Candidaspecies, Gardnerellavaginalis, and Dichomonasvaginahs
ClassificationName: YeastIdentification Kit for Candidaspecies: TrichomonasKit for Tfichomonasvaginalis; None for GardnerellavaginaUs
ClassificationNumber: 83M for Candidaspecies; 83JWZ for Dichomonasvaginalls; None for Gar&wrella vaginalis
3
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3 Predicate Device:
Candidaspecies: Culture: Sabouraud'sDextrose Agar with Chloramphenicol. Microscopy: KOH wet mount Gram stain SlideLatex AgglutinationTest: VagiTestP* (Super Duo***IK892802)
Garidnerellavaginalis: Culture: BBT and V agar Microscopy: Gram stain
Dichomonasvaginalis: Culure: Diamond'smedium Microscopy: Salinewet mount
Vagitest*is a registeredtrademark of CentocorDiagnostics Duo* Super is a registeredtradmark of MorciaDiagnostics Limited
4
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4 Device Description:
4.1 Explanation of the Test
The MicroProbe Affirm' VPmMicrobial Identification Test is basedon the principles of nucleic acid hybridization. Nucleic acid hybridization tests, also known as DNA probe tests, are based on the ability of complementarynucleic acid strandsto align and form specific, double-stranded complexescalled hybrids.
Affirm- The VPui Microbial Identification Test usetwo, single-strandednucleic acid probes, a capture and a color-developmentprobe, that are complementaryto unique geneticsequences of eachof the target organisms. The captureprobe for eachorganism is immobilized on a bead that is embeddedin a card referredto as a ProbeAnalysis Card (PAC). The color-development probe is in a multi-well reagent cassettethat contains the test reagents.
The procedureis outlined in three steps:1) Samplepreparation of the target organism nucleic acid; 2) automatedassay processing; and 3) test resultsreading. During samplepreparation, the sampleis treated with Lysis Solution and then heated. This processruptures the walls of the organisms releasing the nucleic acid. A secondsolution, the Buffer Solution, is added; this solution stabilizes the nucleic acid and establishesthe conditions necessaryfor specific hybridization. The sampleis thenadded to the first well of the ReagentCassette, and automated Affmn- processing begins. The Sample Processor moves the PAC from one wen of the ReagentCassette to another. Hybridization of the target nucleic acid to the DNA probe on the target specificbead occurs in well 1, andthe hybridization of the color-developmentDNA probe occurs in well 2. All unbound sample componentsare washed away in well 3. Enzyme conjugatebinds to the captured color developmentprobe in well 4. Unbound conjugateand probes are washedaway in wells 5 and 6. In well 7 the enzymesubstrate is convertedto a blue-colored product if bound enzyme conjugateis present on the beads.The final step is reading the color developmenton the beads.
5
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4.2 Materials UsedIn the AffirmTmVPm Microbial Identification Test for Candida species,Gardnerella vaginalis, and Trichomonas vaginalis.
PROBE ANALYSIS CARDS (PACs), 24 Twenty-fourindividually Probe Analysis Cards (PACs), wrappedin an absorbentpaper towel moistenedwith a solutioncontaining sodium azide (0. 1 %,w/v) as a preservative.Each card containsfive beads: NegativeControl Trichomonas Gardnerella Candida PositiveControl
REAGENT CASSETTES, 24: Reagentsare sealedin multi-well,foil-covered cassettes. Each cassette has seven wells. From front to back the wellscontain:
Well No. 1: Patient SampleReservoir, suppliedempty
Well No. 2: Hybridization Solution, 350 1& Color developmentprobe Formamide Bufferedchaotropic solution
Well No. 3: Wash Solution, 750 jAl: Detergent Buffer solution Preservative:Proclin
6
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Well No. 4: Conjugate, 500 1AI: Enzyme conjugate Preservative: Proclin
Well No. 5: Wash Solution, 750 1& Detergent solution -Buffer Preservative: Proclin
Well No. 6: Wash Solution, 750 IAI: Detergent Buffer solution Preservative: Proclin
Well No. 7: Buffer Solution, 500 IAI:
SUBSTRATE SOLUTION, 3.4 ml 1 bottle, red cap (in foil pouch) Indicator Substrate Stabilizing agent Alcohol
LYSIS SOLUTION, 9.5 ml I bottle, blue cap Detergent Buffer solution Preservative: Proclin
7
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BUFFER SOLUTION, 15 ml I bottle, green cap Chaotropicsolution Formamide Buffer solution
- FILTER TIPS, 24
MATERIALS REQUIRED BUT NOT SUPPLIED
Available from MicroProbe Corporation:
Affirm- VP SampleCollection Set Affirm- Processor Affirm- Lysis Block (Requiredto heat samplesfor samplepreparation) Timer Thermometer
5 SignificantPerformance Characteristics
PERFORMANCECHARACTERISTICS
Independentinvestigators evaluated the AffirO Wii MicrobialIdentification Test in vaginalsamples. Specimens werefrom women presenting with symptoms of vaginitis/vaginosis or from women at highrisk for infection.
Candidaspecies
Affirm' Thesensitivity and specificity of the VPwMicrobial Identification Test for Candidaspecies were establishedby comparison to conventional microscopy methods and to culture.The performance ofthe Affire
8 4F
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VP.Microbial Identification Test for Candidaspecies was determined in 740 patients. The performance of the Affirre Viii Testfor Candidaspecies and microscopy was evaluated in 479 women who presented with clinical signsand symptoms of yeastvaginitis and in 261high-risk women who were evaluated for someother reason, includingpregnancy (n- 186),family planning, or because they are contacts of STD-positivepatients. A clinically 104 significantlevel of yeastculture isolation ( > cfuper ml vaginal fluid) was used as the comparative method, sincethis levelhas beenshown, in the literature,to be associatedwith yeastvaginitis. Asymptornatic colonizationat low levelsof yeastis common.3, 21 Rawperformance data are displayedin Table1, and reconciledperformance data, after discrepant analysis by an independentmethod, are displayed in Table 2.
TableI AffirMT1 Unreconciled Performance of the Win Microbial Identification Test, Wet Mount Analysis, and Gram stain to Culture Identification of Candida species Test/Culture +1+ + I + + Sensitivity Specificity Accuracy (TP) (FP) (FNI (TN) N N N Allpatients (n=740) 85 26 24 605 78 95.9 93 Wet Mount 59 52 50 579 54 91.8 86 GramStain (n-484) 25 6 35 418 42 98.6 92 Forpatients with presenting symptoms of Vaginitis (n=479) AffirmTm 65 20 17 377 79 95.0 92 WetMount 55 44 27 353 67 88.9 85
GramStain (n-329) 1 23 4 31 1271 43 98.5 89 Fororpatients'a' without presenting symptoms of Vaginitis (n=261) AffirmTm ffirm." 20 6 7 228 74 97.4 95 WWet Mount etMc 4 8 23 226 15 96.6 88 - GramStain (N 155) 2 1 2 1 4 1 147 33 98.7 96
Affirm' Incases of apparent false positive results where the VPwwas positive andthe comparative result was Affirrhm negative,alternate methods were used to confirm the Pinresult. For example inTable 1, there were Affirm' positive" 85 resultswhich were positive byboth culture and by Vinand 26 "apparentfalse samples
9
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Affirm' wet mount whichwere positive by Um andnegative by culture. Thesesamples were examined for identificationof yeast. As seenin Table2, 15 of thesesamples were also wet mountpositive. In thosecases wherethe apparentfalse positives were confirmed by the alternatemethod, the sampleswere moved to the true Table2. positivecategory and the reconciledsensitivity and specificity recalculated and presented in Similarly, the AffiW WinTest was used to reconcilewet mount"apparent false positive samples". Gram stain was not usedto reconcileapparent false positives by wet mountbecause it hadlower sensitivity in this study. Of the 104 remaining11 apparentfalse positive samples, 10 werepositive by culture,but at levelsless than CfUlMl, Affirm' andthe eleventhsample was also positive in a duplicateswab in a second VI'mMicrobial Identification Testfor Candidaspecies.
Theperformance ofthe Affirm' VI'm Test compared to clinically significant culture as presented inTable 8. The sensitivityand specificity was 81% and 98.2%, respectively, ascompared to a sensitivityand specificity of 60% and94.0%, respectively, for wet mountand of 44%and 99.3% by Gramstain, respectively, for identification ofyeast in allwomen. The Affirm' VI'm Test is more sensitive than either wet mount or Gramstain identification of yeastand at clinicallyrelevant levels.
ClinicalPerformance Stratified By InitialPresenting Vaginal Complaint
Additionally,theperformance of these tests was also evaluated on the basis of whetherthe womenentered the clinicwith a complaintof vaginitis, or if theywere considered at high risk of vaginitisand were being seen for someother reason, including pregnancy (n- 186),family planning, or because they were contacts of STD-positive patients.The majority of womenin thistrial had clinical signs and symptoms of vaginitis(640 of 740).
TheAffirem Test provided more objective detection of clinicallysignificant levels of yeast.There was a differencein diagnostic performance bywet mountbased an whetheror not the patients entered the clinic with symptomsof vaginitis or whetherthe visitoriginated for someother reason. Gram stain evaluation was a less sensitivemethod of detectingyeast.
Asseen in Table 2 foridentification ofyeast, in womenwho entered the clinic complaining of vaginal symptoms, Affirnfu therelative sensitivity and specificity of the VPmTest was 82% and 98.4%, as compared to 72% and
10
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92.2%,respectively, for wet mount.These results indicate the two tests,AffirnP Viii andWet mount, perform similarlyin womenwho enterthe cliniccomplaining of vaginitis.Gram stain identification of yeastwas less sensitivethan the othermethods, with a sensitivityand specificity of 46%and 99.6%, respectively.
However,in womenwho entered the clinicfor someother reason, the two testsdid not performsimilarly. Of these261 women,88% were either pregnant or hadsigns or symptomsof vaginitisrecorded during the office Affirmm visit. As seenin Table2, the relativesensitivity and specificity of the Testwas 75%and 97.9%, respectively.The sensitivity and specificity was 18%and 97.0%, respectively, for wet mountand was 33% and98.7% for GramStain, respectively, for identificationof yeast.
The sensitivityof the wet mountevaluation was apparentlyinfluenced by whetheror not the women enteredthe clinic complainingof a vaginalinfection (respectively); or whetherthey were seenfor some AffirMTm other reason(72% vs 18%,respectively). The sensitivity of the Test was not influencedby whetheror not the womenentered the clinic complainingof a vaginalinfection or whetherthey were seenfor some other reason(82% vs 75%, respectively). Sincethe referencemethod, clinically significantculture, remainded the somein both cases,this datasuggests wet mountis moresubjective andoperator sensitive. Since it is well documentedthat symptomsare not well correlatedwith yeast AffirMTM vaginitise,the Mu Test representsan objectivemeasure of clinically significantlevels of yeastin vaginalfluid specimens.The AffirMTm Test results are availableat the time of the office visit. A diagnosisof yeast vaginitis requiresthe presenceof associatedclinical signs and symptomsin additionto demonstrationof the organism.
11
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 00,31 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Table2 ReconciledPerformance of the Affire' Vill MicrobialIdentification Test, Wet MountAnalysis, andGram stain to CultureIdentification of Candidaspecies
Testvs Culture +/+ +I- -/+ + Sensitivity Specificity Accuracy (TP) (FP) (FN) (TN) N N N
All patients(n=740)
Affirm'rm 100 110 24 605 81 98.2 95
WetMount 74 37' 50 579 60 94.0 88
GramStain (n=484) 28 3 35 418 44 99.3 92
ents with presentingsymptoms of Vaginitis(n=479)
AffirmTM 79 6 17 377 82 98.4 95
WetMount 69 30 27 353 72 92.2 88
GramStain (n=329) 26 31 271 99.6 90
Forpatients without presenting symptoms of Vaginitis(N=261)
Affirem 21 5 7 228 75 97.9 95
WetMount 5 7 23 226 18 97.0 89
[Eýain (N= 155) 2 2 4 147 33 98.7 96 . U' Affirm' I U of I I sampleswere positive by culture,but at < I yeastper mi. the eleventhsample was positive by a duplicate Pin Test. ' 11of 37 samples were positive byculture, but at levels < 10' yeast per mi. Ofthe remaining 26,1 waspositive bya duplicate AffirmTMTest, 15 of 15 were negative ona duplicatesmear made from the same swab as the wet mount.
12
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Gardnerellavaginalls
Affirm' Fourindependent investigators evaluated the abilityof the MicroProbe VNi MicrobialIdentification Test to identifyGardnerella vaginalis in vaginalsamples. The studysites included three sexually transmitted disease clinicsand one public health, family-planning clinic. Specimenswere from women presenting with symptomsof vaginitisivaginasisor from womenat highrisk for infection.
AffirmTm Thesensitivity and specificity of the VPiiiMicrobial Identification Test for Gardnerellavaginalis was establishedby comparisonto conventionalmicroscopy methods and to culturein 299 patients.Culture determinationofGardnerella vaginalis is not recommended forthe diagnosis ofbacterial vaginosis due to thehigh numberof womenpositive for Gardnerella vaginalis who do not have clinical bacterial vaginosis. Because of this, 105 mi." theAffirMTm Test was compared to clinically significant levels of G.vaginalis, identified as > cfuper Theperformance of the AffirMTM Vpjjj Microbial Identification Test for Gardnerellavaginalis as comparedto standardreference methods is presentedinTable 3. Table3 UnreconciledPerformance of Methodfor Gardherellavaginalis Identification
Comparison Affirm'VP/Reference Method Sensitivity Specificity Agreement +/+ +I- -/+ "I, (TP) (FP) (FN) (TN) ForGardnerella vaginalis, allpatients (n-299) AffirmTmvsGram 167 4 33 95 84% 96% 88% stainMorphotypes AffirmTm vsCulture 147 24 21 107 88% 82% 85% > 2+
for Gardnerellavaginalis, in patients with clinical BV by 3 of 4 Criteria(n-129) AffirmTm vs;Gram 117 1 6 5 95% 83% 95% stain Morphotypes
EAffirmTmvs;Culture 105 13 2 9 98% 41% 88% , > 2+
13
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As with the Affire Testfor Candidaspecies, the apparentfalse positive samples which were positive by the AffirmTm but negativeby the referencemethod were evaluatedby the alternatereference method. For Gardnerellavaginalis, when Gram stain morphotypes; wasthe referencethe discrepant samples were examined by cultureand when the reference method was culture, the discrepantsamples were evaluated by Gramstain morphology.For cluecalls the discrepantsamples were also examined by Gramstain morphotypes for AffirmTm reconciliation.The percent agreement between the results obtained by the VPMicrobial Identification Testsand current reference methods is lessthan the up to 15% swabto swabvariation seen in other methods.The results are presented in Table 4. Whenevaluated in all women,the Affire Testwas both sensitiveand specific as comparedto the identificationof G. vaginalisby either Gram stain morphology orby clinicallysignificant culture levels. The relative sensitivity and specificity ascompared to Gram stain morphology Affirm' was84% and 100%, respectively. When the Testwas compared to clinically significant culture levels, the AffirMTMPill Testhad a sensitivityand specificity of 89%and 99%, respectively.
14
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Table4 AffirMT1 ReconciledPerformance of. the Vp1j, MicrobialIdentification Test for Gardgerellavaginalis
Reference Affire W/ReferenceMethod Relative Relative Agreement Method Sensitivity Specificity + I (TP) FP) (FN) (TN) ForGardnerella vaginalis, allpatients (n- 299) AffirMTM VS 171 0 33 95 84% 100% 89% Gramstain Morphatypes AffirMTM 931 VS 170 1 21 107 89% 99% Culture> 2+ 1 ForGardnerella vaginalis, inpatients with clinical BV by 3 of4 Criteria(n= 129) Gramstain 118 0 6 5 95% 100% 95% Morphotypes AffirMTM VS 118 0 2 9 98% 100% 98% Culture> 2 +
Trichomonasvaginalis
AffirmTm Thesensitivity andspecificity ofthe VP MicrobialIdentification Testfor Trichomonas vaginalis wereestablished by comparisontoconventional microscopy method and to culture in852 patients. The raw performance datafor the conventionalvaginal fluid sample obtained bydacron swab ispresented inTable 5.
15
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Table 5 Affirrn'ým UnreconciledPerformance of the VP Microbial Identification Test for Trichomo,nasvaxnalts Agreement ReferenceMethod Affire VPiReferenceMethod Sensitivity Specificity
(TP) (FP) (FN) (TN)
SWABSAMPLE (n - 852) Affirmvs WetMount 90 14 8 739 92 98 97
Affirmvs Culture, 99 5 12 735 89 99.0 98 all days 98 Affirmvs Culture, 97 7 9 738 92 99.0 <_ 3 days Wet Mountvs 91 7 20 733 82 99.0 97 Culture,all_days I I I - I I -
AffirrnTm AffirmTm As with the Test for Candidaspecies, the apparentfalse positive samples which were positive by the alternatereference method. Test for Trichomonasvaginalis but negative by the referencemethod were evaluated by the positive" In thosecases where the "apparentfalse resultwas confirmedas positiveby the alternatereference method, the samplewas considered a true positiveand the reconciled sensitivity recalculated. The reconciled performance is presented AffirmTm in Table6. The relativesensitivity and specificity of the VNi MicrobialIdentification Test for Trichomonas vaginalisis 93% and99.9%, respectively,as comparedto wet mountidentification of T vaginalis.Compared to a 5 to Affirm' 7 day Diamond'sculture, the relativesensitivity and specificity of the Test are 90% and 99.9%respectively. Sincemuch of the Diamond'sculture available is for a 48 to 72 hourincubation, the sensitivityand specificity was VNI Microbial calculatedusing this as the referencestandard also. Therelative sensitivity and specificity of the Affire IdentificationTest as comparedto 48 to 72 hourDiamond's culture identification of Trichomonasvaginalis was 92% and AffirmTm 99.9%,respectively. In thisclinical evaluation, the VPIIIMicrobial Identification Test wascomparable in sensitivity to 5-7 day cultureisolation of Trichomonasvaginalis.
16
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Table6 AffirmTm ReconciledPerformance of the VI'm MicrobialIdentification Test for Trichomonasvagifialis
Reference Test/Reference Method Relative Relative Agreement Method Sensitivity Specificity % +J+ + % % (TP) FP) (FN) (TN)
SWABSAMPLE (n - 852)
AffirMTMvs: Wet 103 8 739 93 99.9 99 Mount
AffirmTm vs 103 1 12 735 90 99.9 99 Culture,all days
AffirmTmvs 102 1 9 738 92 99.7 99 Culture,< 3 days
WetMount vs: 95 3 20 733 83 99.6 97 Culture,all days I I I I I I I I
VaginalWash Sample Collection
In onelaboratory, analternate specimen collection method was also evaluated in 106 patients. At thissite, an additional samplewas obtained by instilling3 ml of sterilesaline into the vagina as a vaginalwash. The solution was retrieved and transferedinto the Sample Collection Tube. Once received at thelaborabory, 0.3 ml ofthe vaginalwash was removed and examinedby conventionalwet mount analysis for motiletrichomonad. The Sample Collection Tube containing the vaginal
17
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AffirmTm washsample was centrifuged, and the supernantdecanted. The sensitivity and specificity of the Wii Microbial vs; IdentificationTest for Trichomonasvaginalis using a vaginalwash sample was 87% (47155) and 98% (51152) 5-7day wasalso cultureisolation of T. vaginalisusing Diamond's medium. The one apparent false positive by the AffirmTMTest and100% respectively. positiveby wet mount,giving a reconciledsensitivity and specificity of 87%(48155) (51151),
NOWCLINICAL RESULTS
A total of 88 isolatesrepresenting 34 differentgenera of microorganismsidentified by Isenberget al asclinically relevant tract' Affirmm to thegenitourinary weretested in the ffiii MicrobialIdentification Test as shownin Table7.
Table 7 Vaginal Floraand Other Organisms Tested for Specificitywith Affirm"Piii MicrobialIdentification Test Organism Number Organism Namber Acketobactersp. 1 Listeriamonocytogenes 1 Actinomycessp. 1 mobiluncusspp. 3 Bacteroidesspp. 4 Mycobacteriumsp. Branhamellasp. 1 Mycoplasmahominis Bifidobacteriumsp. 1 Neisseriasp p. 2 Campylobactersp. 1 Neisseriagonorrhoeae Candidaspp. 16 Peptococcussp. Chlamydiatrachomatis 2 Paptostreptococcusspp. 3 Clostridiumspp. 2 Prevotellaspp. 2 Corynebacteriumspp. I Porphyromonassp. Cryptococcusneoformans I Propionibacteriumsp. Entamoebasp. 1 Pseudomonassp. Enterobacteriaceas 5 Staphylococcusspp. 3 Enteracoccussp. 1 Streptococcusspp. 3 Fusebacteriumsp. 1 Trichomonasvaginalis 9 Gardnerellavaginalis 10 Ureaplasmaurealyticum 1 Haamophilusducreyi 1 voillonellasp. Lactobacillusspp. 3 Other 1
18
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Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Affirmm All of the organisms,except Cryptococcus neoformans and Candida species were nonreactive inthe VP111Microbial IdentificationTest for Candidaspecies at a concentrationof 10' bacteriaper mi.
Allof the organisms,except Mobiluncus Inulieris, Bifidobacterium dentium, and Gardnerella vaginalis were nonreactive in theAffirm' VP Microbial Identification Test for Gardnerelkvaginalis at a concentrationof 108 bacterialmi. Mobiluncus 8x1O' Inulieriswas nonreactive at a concentrationof 410' bacterialmi,and Bifidobacterium d.-ntium was non-reactive at bacterialmi.Bffidobacterium dentium is onlyvery rarely recovered from the vagina. Most8ffidobacterium sp.and strains of B. dentiumare recovered from body sites other than the vaginaor urogenitaltract.
Allof the organisms,except Trichomonas vaginalis were nonreactive in the Affirm7 VP Microbial Identification Test for Trichomonasvaginalis at a concentrationof 10' bacterialml.
f 19
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6 Intended Use The MicroProbe Corporation Affu-m- VPm Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species, Gardneretlavaginalis, and Trichomonas vaginalis nucleic acid in vaginal fluid specimensfrom patientswith symptomsof vaginitis/vaginosis.
20
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7 Technological Characteristics
The Affirm"m VPm Microbial Identification Test for Candida species compares to culture, microscopic
methods, and latex aggultination test as follows:
Table 8 Method Comparison for Identification of Candida species (yeast)
AFFIRM- WET MOUNT GRAM STAIN VagiTese CULTURE (SuperDuo -K#892802)
Sample Vaginalswab Vaginalswab Vaginalswab Vaginalswab Vaginalswab
Transport Dry tube Dry or saline None or transport Salinefilled tube Transport medium filledtube medium
Transport/ 4hr0-8'C or lhr Minimal Same day None Same day Holding RT Tijrne
Sample Add Solutions Mix vaginal Rollswab on slide, Agitateswab 10 Rollswab on Preparation andheat fluidwith 2 airdry, heat fix seconds,remove Sabouraud'splate, dropsof 10% swab streakfor KOH on slide isolations,incubate plate35-37oC for 48 hours
Test Add sampleto Examine Add crystalviolet, Add sample,add Examineplates for Procedure reagentcassette, microscopically wash, add iodine, 2 controls,add growth,Gram placePAC, forbudding wash,decolorize, solution, mix with staincolonies sampleprocessed yeast or counterstain,wash, separatemixing automatically pseudohyphae blotdry. Examine sticks.Examine microscopicallyfor visuallyfor peudohyphae/budding agglutination. yeast
Principle DNA Morphology Color,morphology Antibody-antigen Growthon selective hybridization agglutination media,gram stain reaction result
TestResults Candida species Yeast Yeast Yeast Yeast TestTime 40 min 5 - 10 min 5 - 10 min 2 min 48 hours Read Thne Immediate I - 5 min 1 -5 min 1-5min 5 - 10 min
Quantitation Qualitative Qualitative Qualitative Qualitative Qualitativeýor Semi-quantitative I I I I I
21
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Gardnerella ygginalls
The Affirm' VP Microbial Identification Test for the identification of Gardnerella vaginalis is comparable to the use of culture and Gram stain for G. vaginaUs. Table 9 summarizes the similarities and differences of these 3 methods.
Table 9 Method Comparison for Identification of GardnereUa vaginalis F_ 7-AFFIRM- _J ýZRAM STAIN -T CULTURE Sample Vaginal swab Vaginalswab Vaginal swab
Transport Dry tube Transportmedium Transportmedium TransportTime 4hr 0-8'C or I hr RT Sameday Sameday SamplePreparation Add Solutionsand Roll swabon slide, Roll swabon plate,streak heat air dry, heat fix with loop, incubateplate Test Procedure Add Solution,add Add crystal Examineplates sample,place PAC, violet,wash,add Gram stain sampleprocessed iodine,wash, Test for productionof automatically decolorize, catalase counterstain, wash, blotdry
Principle DNA hybridization Color,morphology Growth, colony appearance, Gram stain+ Catalase test
Results Speciesspecific, Gardnerella Species-Testspecific identifiesGardnerella vaginalis or vaginalis Bacteroidesspp TestTime 40 min 5 - 10 min 24 -72 hours Read Time Immediate I -5 min 5 - 10 min
Quantitation Qualitative Semi-quantitative Qualitative or semi-quantitative
22
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Tilchomorm =inali
The Affirm- VP Microbial Identification Test for the identification of THchomonasvaginaUs is comparableto the use of saline wet mount and culture for T. vaginalis. Table 10 summarizesthe similaritiesand differences of these3 methods.
Table 10 Method Comparisonfor Identification of Trichomonasvaginahs
CULTURF, MMRM-. WET MOUNT I Sample Vaginalswab Vaginalswab Vaginalswab
Transport Dry tube Dry or salinefilled Isolation Medium tube TransportTime 4hr0-8'C or lhr Minimal Same day RT Sample Add Solutionsand Mix vaginalfluid Placeswab in Preparation heat with2 dropsof Diamond'sMedium 0.85 % NaCl on slide
TestProcedure Add Solution,add Examinemicro- Incubatefor up to7 sample,place PAC, scopicallyfor motile days,prepare wet sampleprocessed trichomonads mountsdaily and automatically examine microscopicallyfor motiletrichomonads
Principle DNA hybridization Characteristicmotility Characteristic and morphology;host motilityand specificityof morphology;host trichomonads specificityof trichomonads TestResults Speciesspecific, Speciesspecific, Speciesspecific, identifies identifies identifies Trichomonas Tilchomonas THchomonas vaginalis vaginaUs vaginalis TestTime 40 min 5 - 10 min Up to7 days Read Time Immediate 5 - 10 min 5 - 10 min
Quantitation Qualitative Qualitative Qualitative
23
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SECTION H
510(k) PREMARKET NOTTFICATION
Affmn- VPm Microbial Identification Test for Candidaspecies, Gardnerella vaginalis, and Tfichomonasvaginalis
24
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510(k) PREMARKET NOTIFICATION
Affmn.. VRii Microbial Identification Test for Candidaspecies, Gardnerella vaginalis, and Trichomonasvaginalis
I ProductIdentification: Affirm- ProprietaryName: VPm Microbial IdentificationTests for Candida species,Gardnerella vaginalis, and THchomonas vaginaUs
CommonName: DNA ProbeTests for Detectionof Candida species, Gardnerellavaginalis, and DichomonasvaginaUs
ClassificationName: YeastIdentification Kit for Candidaspecies; TrichomonasKit for Tfichomonasvaginafts; None for GardnerellavaginaUs
ClassificationNumber: 83JXB for Candidaspecies; 83JWZ for Tilchomonasvaginalis; None for GardnerellavaginaUs
2 EstablishmentRegistration Number: 3025262
3 DeviceClassification: Unknown
4 Compliancewith Performance Standards: Not Applicable
5 ProposedLabels, Labeling, and Advertisements: The proposedlabels and labelingfor this device are included in this submission in SectionIn.
6 Informationand Datato Support Substantial Equivalence Informationand Datato Support Substantial Equivalence follows.
25 W46 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
510(k) PREMARKET NOTIFICATION Affirm' VPni Microbial Identification Test for Candidaspecies, Gardnerellavaginalis, and Tfichomonasvaginalis Informationand Data to SupportSubstantial Equivalence
1 DeviceDescription
The MicroProbeAffirm- VPm Microbial IdentificationTest is a DNA probetest for the detectionof Candidaspecies, Gardnerella vaginalis, and DichomonasvaginaUs in female vaginalspecimens. The major componentsof the kit are:
PROBE ANALYSIS CARDS (PAQ: Twenty-fourindividually packaged cards. Each card contains5 beads:a Positive Control, a NegativeControl and a beadfor the microbial identificationof Candidaspecies, Gardnerella vaginalis, and Tfichomonasvaginalis.
REAGENT CASSETTES : Reagentsare sealed in multi-well, foil-coveredcassettes. Each cassettehas sevenwells.
SUBSTRATE SOLT-MON
LYSIS SOLUTION
BUFFER SOLUTION
FILTER TIPS
The MicroProbeAffirm- VPmMicrobial Identification Test is basedon the principles of nucleic acidhybridization. Nucleic acid hybridization tests, also known as DNA probetests, are based
26 or
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double-stranded on the ability of complementarynucleic acid strandsto align and form specific, complexescalled hybrids.
The Affirm- VPm Microbial Identification Test usestwo, single-strandednucleic acid probes, a captureand a color-developmentprobe, that are complementaryto unique geneticsequences of each of the target organisms. The capture probe for each organism is immobilized on separatebeads that are embedded in cards referred to as Probe Analysis Cards (PACs). The color-developmentprobe is in a multi-weH reagentcassette that containsthe test reagents.
The procedure is outlined in three steps:1) Samplepreparation of the target organismnucleic the acid; 2) automatedassay processing; and 3) test results reading. During samplepreparation, sample is treated with Lysis Solution and heated. This process ruptures the walls of the organismsreleasing the nucleic acid. A secondsolution, the Buffer Solution, is then added;this solution stabilizes the nucleic acid and establishesthe conditions necessary for specific hybridization. At this point, the sampleis addedto the first wefl of the ReagentCassette, and AffmnTm automatedprocessing begins. The VPiu SampleProcessor moves the PACs from one weU of the ReagentCassette to another.Hybridization occurswhen the PAC entersthe first and secondweUs of the ReagentCassette. Hybridization of the target nucleic acidto the DNA probe on the target specific bead occurs in well 1, and hybridization of the color-developmentDNA probe occurs in well 2. All unbound samplecomponents are washedaway in well 3. Enzyme conjugate binds to the captured color developmentprobe in well 4. Unbound conjugateand probes are washedaway in wells 5 and 6. In well 7 the enzymesubstrate is convertedto a blue-colored product if bound enzyme conjugate is present on the beads. The final step is readingthe color developmenton the beads.
*V 27
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2. Comparisonto Other Devices in Commercial Distribution
The comparisons of the Affirm.. VPLuMicrobial Identification Test for Candida species, Gardnerella vaginalis, and Pichomonas vaginalis havebeen previously describedin premarket notifications as indicatedbelow.
Afrtrtn7 Win Aficrobial Identification Test for: Candida species: Submitted3/5/93
Culture: Sabouraud's Dextrose Agar with Chloramphenicol Microscopy: KOH wet mount Gram stain Slide Latex AgglutinationTest: VagiTestg* (SuperDuo"**/K892802)
GardnereHavaginalis: (K 923133)
Culture: HBT andV agar Microscopy: Gram stain
Trichomonasvaginalis: (K 923133 andK922457/A) Culure: Diamond'smedium Microscopy: Salinewet mount
Vagitest* is a registeredtrademark of CentocorDiagnostics Duo* Super is a registeredtradmark of MarciaDiagnostics Limited
28 ,t,
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3. Comparison Study
3.1 Clinical Sites, Number of Patients and Personnel
Individual investigators,study sites,number of patientstested, and the personnel who performed the Affirni'm VPm Microbial identification Test for Candidaspecies, Gardnerella vaginalis and Dichomonasvaginalls are listedin Table I -
29
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Pages 74 through 79 redacted for the following reasons: ------(b)(4), (b)(4)-Raw Testing Data, clinical sites and testing protocols.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Table 4 Vaginal Flora and Other Organisms Tested for Specificity with Afrffmi- VPm NEcrobial Identification Test for Candida species
Organism Number Frequencyof Disease Tested Isolation Involvement A cinetobactersp. 1 B 2 Actinomycessp. I B 2 Bacteroldesspp. 4 A 2 Bffidobacteriwnsp. 1 C I Campylobactersp. I C 2 Candidaspp. 16 B 2 Chlamydiatrachomatis 2 B 2 Clostildiumspp. 2 A 2 Coryneb"tefiumsp. 1 B 1 Cryptococcussp. I C 2 EntamoebaIdstolytica 1 C 3 Enterobacteriaceae 5 A 2 Enterococcussp. I B 2 Gardnerellavaginalis 10 B 2 Haemophilusducreyi I B 3 Lactobacillusspp. 3 A I Listefiasp. I C 2 Mobiluncusspp. 3 B 2 Mycobactefiwnsp. I B 2 Mycoplasmahominis 1 B 2 Neisseriagonorrhoeae I B I Neissefiaspp. 2 B I Peptostreptococcusspp. 3 B I Propionibactedwnsp. I B 1 Pseudomonassp. I B 2 Staphylococcusspp. 3 A 2 Streptococcusspp. 3 B 2 Trichomonasvaginalis 9 B 3 Ureaplasmaurealyticum I B I Others Undetermined
The frequencyof isolationand diseaseinvolvement forthe genitourinary tract is from thetable published by Isenbergand D'Amato ',. A=Commonly encounteredinclinical specimens; B =Occasionally encountered inclinical specimens; C =Rarely encounteted inclinical specimens. 1=Rarely involved in disease;2=Occasionally involved in disease; 3=Commonly involvedin disease.
36 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 0057 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
A list of the 89 isolates of bacteria, fungi and protozoa, and one human cell line is shown below with American Type Culture Collection (ATCC) number or University of Washington (UW) number, CentraalbureauVoor Schimmelcultures,The Netherlands (CBS) number, or Culture Collection of the University of Goteburg, Sweden(CCUG) number in Table 5 . Organismswere testedat a concentration of 2 x 101cells per ml.
Table 5 Organisms Tested in Specificity Challenge
Organism ATCC Number 1. Acinetobactercalcoaceticus 15308 2. Actinomycesisraelff, type 1 12102 3. Bacteroidescapillosus 29799 4. Bacteroidesfragilis 25285 5. Bacteroidesureolyticus 33387 6. Bacteroidesvulgatus 8482 7. Bifidobactetiumdentium (vaginal strain) 27679 8. Branhamellacatarrhalis 25238 9. CampylobactercoU 33559 10. Candidaalbicans 10231 It. Candidaalbicans 11006 12. Candidaalbicans 14053 13. Candidaalbicans 18804 14. Candidaalbicans 24433 15. Candidaalbicans CBS 1893 16. Candidaalbicans CBS 2688 17. Candidaalbicans CBS 2689 18. Candidaalbicans CBS 2706 19. Candidaalbicans CBS 2717 20. Candidaalbicans CBS 2738 21. Candida(Torulopsis) glabrata 2001
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22. Candida kefyr 4135 23. Candidakmsei 14243 24. Candidaparapsilosis 22019 25. Candidatropicalis 750 26. Caski cells (Papillomavirus) 27. Chlamydiatrachomatis serovarE 28. Chlamydiatrachomatis serovarL2 29. Clostfidiumperfringens 13124 30. Clostridiumramoswn 13937 31. Corynebactetiumsp. 17992 32. Cryptococcusneofonnans 32719 33. Escherichiacoli 11775 34. Entamoebahistolytica 30042 35. Enterobactercloacae 13047 36. Enterococcusfaecalis 19433 37. Fusobactetiumgonidiaformans 25563 38. Gardnerellavaginalis UW bio 1 39. Gardnerellavaginalis UW bio 2 40. Gardnerellavaginalis LTWbio 3 41. Gardnerellavaginalis UW bio 4 42. Gardnerellavaginalis UW bio 5 43. Gardnerellavaginalis UW bio 6 44. Gardnerellavaginalis UW bio 8 45. Gardnerellavaginalis CCUG 26756 46. Gardnerellavaginalis CCUG 26996 47. Gardnerellavaginalis 14018 48. Haemophilusducreyi 33940 49. Klebsiellapneumoniae 13883 50. Lactobacillusacidophilus 4356 51. Lactobacilluvcasei rhamnosus 7469 52. Lactobacillusjensenii 25258
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53. Listeria monocytogenes 15313 54. Mobiluncuscurtisii curtisii 35241 55. Mobiluncuscurtisii holmesii 35242 56. Mobiluncusmulieris 35243 57. Mycobacteriumsmegmatis 35242 58. Mycoplasmahominis 59. Neisseriagonorrhoeae 19424 60. Nelsseriameningitidis 13102 61. Neisseriasicca 29259 62. Peptococcusniger 27731 63. Peptostreptococcusanaerobius 27337 64. Peptostreptococcusmicros 33270 65. Peptostreptococcustetradius 35098 66. Porphyromonasasaccharloytica 25260 67. Prevotellabivia 29303 68. Prevotellamelaninogenica 25845 69. Propionibacteriumacnes 6919 70. Proteusmirabilis 29906 71. Pseudomonasaeruginosa 10145 72. Serratiamarcescens 13880 73. Staphylococcusaureus 12660 74. StaphylococcusepidermOs 14990 75. Staphylococcussaprophyticus 15305 76. Streptococcusagalactiae 13813 77. Streptococcuspyogenes 19615 78. Streptococcusintennedius type 1 27335 79. Tilchomonasvaginalis 30092 80. Dichomonasvaginalis 30184 81. Tfichomonasvaginalis 30185 82. Tfichomonasvaginalis 30188 83. Tfichomonasvaginalis 30236
39 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 OMO Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
84. Tilchomonasvaginalis 50138 85. Pichomonasvaginalis 50143 96. Pichomonasvaginalis 50146 87. PichomonasvaginaUs 30001 88. Ureaplasmaurealydcum 89. Veillonellaparvula 10790
All of theseorganisms, except Candida species and Cryptococcusneoformans were nonreactivein the Affirm"mVPm Microbial IdentificationTest for Candida speciesat a concentrationof 10' per mt. Cryptococcusneoformans is only rarely encountedin genitourinarytract specimens,and in only occationallyassociated with diseasein this site when found.
All of the organisms,except Mobiluncus muliefis, Bifidobactedum dendum, and Gardnerellavaginalis were nonreactivein the Affirm- VP Microbial IdentificationTest for Gardnerellavaginalis at a concentrationof 10' bacteria/ml. Mobiluncusmuliefis was nonreactiveat a concentrationof 4xlO' 8xlO1 bacteria/ml,and Bifidobacteriwn dentiwn was non-reactive at bacteria/mt.Bifidobacterium dentiwn is only very rarely recoveredfrom the vagina. Most Bifidobactefiwnsp. and strainsof B. dentiumare recoveredfrom body sitesother thanthe vaginaor urogenitaltract.
All of the organisms,except Pichomonas vaginalis were nonreactivein the AffirmTmVP Microbial IdentificationTest for Pichomonasvaginalis at a concentrationof 10' bacteria/ml.
A summaryof this list is providedin the draft packageinsert included in this submission.
*V
40 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 WGI Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
6 ANALYTICAL SENSITIVITY
The Affmn- VPiu Microbial Identification Test for Candidaspecies can detect 1 x 104 cellsof Candida speciesin log phase per assay.
7 INTERFERING SUBSTANCES
The presenceof anti-fungalmedication, vaginal lubricants,douches, and mensesinterference were recordedduring the clinicaltrial. No evidenceof interferencewas determinedin clinicalstudy.
8 REPRODUCIBILITY
(b)(4)
ýr
41 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 OM2 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Pages 86 through 89 redacted for the following reasons: ------(b)(4), (b)(4)-Raw Testing Data, clinical sites and bench testing protocols. (b)(4), (b)(4)-Raw Testing Data, clinical sites and testing protocols.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
9.2 Line listing of Patient Data, Sorted by Investigator
A line listing of the patient data obtained in this clinical study follows the references.
10 CONCLUSION
Affu-m- The MicroProbe VPm Microbial Identification Testfor Candidaspecies is substantiallyequivalent to the standardreference methods (microscopic evaluation via Gram stainor wet mount, and culture identification)for the directdetection of Candidaspecies (yeast) in vaginalspecimens. The design of thisproduct is the sameas our previouspremarket notifications, K922457, for theMicroProbe MicrobialIdentification Test for Trichomonasvaginalis, cleared September 25, 1992,and K923133, Affirm-VP for the MicroProbeAffirm' VP Microbial Identificationfor Gardnerellavaginalis and Trichomonas vaginalis,also cleared September 25, 1992.
46 -0 NW7 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
References
Isenberg, Henry D., and Richard F. D'Amato. 1991. Indigenous and pathogenic microorganisms of humans. Manual of Clinical Microbiology, 5th ed., Baflows, Hausler, Herrmann, Isenberg, Shadomy (ed.), ASM, Washington, DC, p.8.
47 00"r Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
tv
0069 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
SECTIONIII
ProposedLabeling AffirMTM Vp111Microbial IdentificationTest for Candidaspecies, Gardnerella vaginalis, and TrichomonasVaginalis
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 1--__ ý
Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Aff irm'mWo MicrobialIdentification Test 24 Test 1Gt CatalogNumber 805228
INTENDED USE
The MicreProbeCorporation Aff1rMT1 Vp111 Microbial Identification Testis a DNA probetest intended foruse in the detection and identification ofCandida species, Gardnerella vaginalis, and 7fichomonas vaginalisnucleic acid in vaginal fluid specimens from patients with symptoms of vaginitisivaginosis.
ForIn Vitro Diagnostic Use
CLIACategorization: Moderate Complexity
EXPLANATION OF THE TEST
Introduction AffirMTM The VPiiiMicrobial Identification Testdetects the presence of Candidaspecies, Gardnarella vaginalis, and Trichomonasvaginalis invaginal fluid specimens from patients with symptoms of vaginitisivaginosis and providesthe results inless than 45 minutes.
Vaginitis,oneof the most common problems in clinical medicine, accounts for more than 10 millionphysician year.' officevisits each The threemain categories ofvaginitis arebacterial vaginosis (BV), yeast vaginitis (candidiasis),and Trichomonas vaginalis vaginitis (trichomoniasis) . Bacterial vaginosis isthe most common population.' vaginalinfection, andaccounts for 15% to50% of vaginitisivaginosisdependingupon the patient Thecomplications ofBV canbe especiallysignificant inpregnant women, resulting inincreased risk of adverse ',' pregnancyoutcome, includingpre-term labor, and birth. Vaginalcandidiasis isthe second most common settings.' formof vaginal infection seen in varied clinical Threequarters ofall adult women willexperience at leastone episodeof vaginalcandidiasis during their lifetime, with 40-50% experiencing a second episode. infection.' Approximately5% of the adult female population suffers from recurrent, often intractable yeast Trichomoniasis,a non-reportable sexually-transmitted disease,has been estimated toaffect 180 million annually worldwidelo andin the US anestimated 3 million women contracttrichomoniasis eachyear."
Clinicalsigns and symptoms alone are often used to diagnose vaginitis. However, symptoms are subjective and clinicalsigns of differenttypes of vaginitisarenot distinct enough to clearlydifferentiate thediagnosis. Inadequatediagnosis occurs because of the overlap ofsymptoms associated with different types of vaginitis and theunreliability ofpatients own symptomaticassessment. Accuracy of diagnosis isincreased when clinical signs
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andsymptoms are correlated with the microbialevaluation of vaginalmaterial.'
Thedifferential diagnosis for vaginalinfections includes identification of the causativeagent and assessment of the associatedclinical condition,' as seenin Table1.
TableI VaginitisPathogens and Associated Signs and Symptoms
Vaginitis CausativeOrganism ClinicalSigns and Symptoms
Bacterialvaginosis G8rdnerallav8glfl8lis Thinhomogeneous adherent discharge PrevoteI18h1via Amineodor Bacteroidesspecies llckfo"ells" Mycoplasmahorninis pH > 4.5 mobiluncusspp.
Trichomoniasis Trichomonasvaginalis Yellow,frothy, or purulentdischarge Abnormalvaginal odor Pruritus pH > 4.5
Yeastvaginitis Candidaspecies Pruri'tis (Candidiasis) Abnormaldischarge Soreness,irritation, burning Epitheliumwhite plaques pH< 4.5
Laboratorymethods for the identificationof these organisms include microscopic evaluation of the vaginal discharge,Gram stain, and culture. Microscopic examination of a salinewet mountis performedunder a calls" standardbright field microscope, or by phasecontrast for the detectionof "clue and/ormotile trichomonads.Clue cells are epithelial cells which have bacteria adhering to the surface. The addition of 10% KOHto the vaginaldischarge specimen allows the detectionof an amineodor, and clears the specimen for 12 betterobservation of budding yeast or pseudohyphein the vaginal discharge.
Althoughculture identification of Gardneralla vaginalis and Candida species is a sensitivemethod for detecting theseorganisms, culture at low levelsis not usefulin the absenceof associatedsigns and ","' positivity clinically symptoms. Commensalcarriage, or colonizationiscommon with these organisms, and their presence alone is notsufficient for a diagnosisof vaginitis.This is notthe casewith Trichomonasvaginalis, where the identificationof this organism requires therapy. Culture is a sensitivemethod for detectingTrichomonas, but thesensitivity is affected by different isolation media and the duration of culturewhich effects the sensitivity of culture.
2 a Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118W*t Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
WhileG. vaginalisis no longer thought to bethe only etiologic agent of BV,it is stillconsidered to be one of bacteria to the infection,and is the bacteriafound on cluecells. Therefore, the major contributing primary cells" detectionand identification of G. vaginalisis an importantmarker in diagnosisof BV. "Clue representa measureof increasedlevels of G. vaginalisto the physician.
An alternativelaboratory test for BV is the use of Gram-stainedvaginal smears read for bacteria[ morphotypes.",","A direct comparison between culture, Gram stain and diagnosis byclinical criteria indicated that G. vaginalisculture had excellentsensitivity, but lowspecificity, while the Gramstain had moderate 21 sensitivitywith good specificity and a muchhigher predictive value of positiveresult.
In certaincases, the complicationsof BV canbe significant.More than half of all womenwith bacterial vaginosishave no symptoms.Pregnant women with disturbed vaginal flora of BVhave an increasedrisk of 4 chorioamnionitis,'post-cesarean' post-parturn' intra-amnioticinfection, and endometritis,adverse pregnancy outcome," labor" birth.'1,12,11,14 Microbial invasion of the amnioticcavity has been andpro-term and pre-term term.'s reportedas a riskfactor for endometritis in women with premature rupture of membranesat Additionally, CallUlitiS.16 BVis a riskfactor for thedevelopment of post- hysterectomy Cuff Accordingly,theimportance of BV diagnosishas increased. membranes," Pregnantwomen positive for Trichomonasvaginalis were more likely to havepre-term rupture of birth.'1,21 as wellas pre-termlabor and T vaginalisis a riskfactor for the developmentof post-surgical infectionS21 gynecologic andin patientsundergoing first trimester pregnancy termination, those with T. vaginalis were more to post-operativepelvic infections than were uninfected patients. Similar significantly likely develop cellulitiS.22 to T. vaginalisis a riskfactor for the developmentof post-hysterectomy cuff Additional BV, ascites," complicationsinclude case reports of abdominopelvic althoughthis is aninfrequent sequelae.
MicroProbeCorporation has designed the Affirm'VPw Microbial Identification Test to detectthe presenceof Gardnerellavaginalis, Candida species and Trichomonas vaginalis in vaginal fluid specimens from patients with symptomsof vaginitis/vaginosis andto provideresults in lessthan 45 minutes.
PRINCIPLESOF THE TEST
The Affirm" Wii MicrobialIdentification Test is based on the principles of nucloic acid hybridization. Nucleic acidhybridization tests, also known as DNAprobe tests, allow complementary nucleic acid strands to form specific,double-stranded complexes called hybrids.
TheAffirm' Viii MicrobialIdentification Test uses two, single-stranded nucloic acid probes for eachorganism, a captureprobe and a colordevelopment probe, that arecomplementary to unique genetic sequences of the targetorganisms. The capture probe is immobilizedona beadembedded in a ProbeAnalysis Card (PAC) which containsa separate bead for eachtarget organism. The color development probe is containedin a multi-well ReagentCassette.
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The procedureis outlinedin threesteps: 1) samplepreparation to releasetarget organismnucleic acid; 2) automatedassay processing; and 3) readingtest results.During sample preparation, the sampleis treatedwith LysisSolution and then heated. This process ruptures the walls of the organisms,releasing the nucleicacid analyte.A secondsolution, the BufferSolution, is added;this solutionstabilizes the nucleicacid and establishes the stringencyconditions necessary for specifichybridization. At thispoint, the sampleis addedto the first well Affirm' of the ReagentCassette along with the PAC,and automated processing begins. The Processormoves the PACfrom one well of the ReagentCassette to another.Hybridization occurs on the PACbeads in the first andsecond wells of the ReagentCassette. Hybridization of the analyte to thecapture probe an the bead occurs in well #1, andthe hybridizationof the biotinylatedcolor development probe occurs in well #2. All unbound samplecomponents and probes are washedaway in well #3. Streptavidin-horseradishperoxidase (enzyme conjugate)binds to the capturedanalyte in well #4. Unboundconjugate is washedaway in wells#5 and#6. In well 7, the substrateis convertedto a blue-coloredproduct if boundenzyme conjugate is presenton the bead. Thefinal stop is readingthe resultsof colordevelopment on eachof the targetorganism beads and controls. Thetest principlesand procedures are shown in Figures1 and2, respectively.
REAGENTS
MaterialsProvided
1. PROBE ANALYSISCARDS (PACs) 24
Twenty-fourindividually packaged cards, wrapped in an absorbentpaper towel moistened with a solution containingsodium azide (0.1%,wiv) asa preservative. Eachcard contains fivebeads: NegativeControl (1) Tricbomonas (1) Gardnerella (1) Candida (1) PositiveControl (1)
2. REAGENTCASSETTES 24
Reagentsare sealed inmulti-well, foil-covered cassettes. Each cassette hasseven wells. From front to back thewells contain:
WellNo. 1: PatientSample Reservoir, supplied empty
WellNo. 2: HybridizationSolution, 350 /jL: Colordevelopment probe Formamide Bufferedchaotropic solution
WellNo. 3: Wash Solution,750 /jL: Detergent
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ReleasedTarget Bead with CapturedTarget NucleicAcid Capture Probe Nucleic Acid
+ VO
Colorless Color Development Substrate Probe
Colore Result: Product Hybridof: Capture Blue EnzymeConjugate Probe; Bead TargetNucleic Acid; Color DevelopmentProbe
PAC
Substrate Wash Wash 3 Conjugate 1 Wash Reagent Well Color Development Probes Cassette Capture Probes on Beads
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Buffersolution Preservative:Proclin
WellNo. 4: Conjugate,500 /jL: Enzymeconjugate Preservative:Proclin
WellNo. 5: WashSolution, 750 pL: Detergent Buffersolution Preservative:Proclin
WellNo. 6: WashSolution, 750 1.& Detergent Buffersolution Preservative:Proclin
WellNo. 7: Buffer Solution,500 /jL:
3. SUBSTRATESOLUTION, 3.4 mL 1 bottle,red cap (in foil pouch) IndicatorSubstrate Stabilizingagent Alcohol
4. LYSISSOLUTION, 9.5 mL 1 bottle,blue cap Detergent Buffersolution Preservative:Proclin
5. BUFFERSOLUTION, 15 mL 1 bottle,green cap . Chaotropicsolution Formamide Buffersolution
6. FILTERTIPS, 24
MaterialsRequired But Not Supplied
Availablefrom MicroProbeCorporation: Affirm' VPSample Collection Sets Affirm' Processor Affirm' LysisBlock (Requiredto heatsamples for samplepreparation) Timor Thermometer
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WARNINGS AND PRECAUTIONS
GeneralPrecautions for Use
Forin vitrodiagnostic use only.
Forspecimen collection, use only the Affirm'VP Sample Collection Set.
Useonly vaginal fluid specimens from patients with symptoms of vaginitisivaginosis.
SafetyPrecautions
SubstrateSolution contains alcohol and is combustible.Keep away from heat, sparks, and flame. Keepcontainer tightly closed to preventevaporation.
Reagentscontain ingredients that could be irritating or causticif allowedto comein contactwith skin,eyes or mucousmembranes. Wear gloves when handling. If swallowed, call a physician.In caseof skinor eyecontact, flush with copious amounts of water.
Handleand dispose of specimensas if theyare capable of spreadinginfectious disease. Proper handlinganddisposal methods should be established. Wipeup any spillage ofpatient specimens or reagentsimmediately anddisinfect withan appropriate disinfectant. Treatthe cleaning materials as biohazardouswaste.
Monitorthe temperature ofLysis Block, 85 + VC.
Thereis sodium azide (0.1%,wlv) inthe solution moistening thepaper that surrounds thePAC.
[Warning:Sodium azide may reactwith lead or copper plumbing toform highly explosive metal azides. Thiscan he preventedbyflushing any disposal with large volumes of water. For further information, consultthe safety bulletin on azide handling published by NIOSHJ
HandlingPrecautions
Readall instructions carefully before use.
Avoidtouching thebeads.
Avoidcontaminating tipsof dropper bottles.
Do notuse a reagentafter its expiration date.
Do notmix materials from kits with different lotnumbers.
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PREPARATIONOF REAGENTS
All reagentsare suppliedready for use.
StorageOf Reagents
TheAffirm' Wii MicrobialIdentification Testkit is stable until the expiration dateindicated onthe kit box when storedat 2 toB*C. Alternatively,storeat room temperature (upto 30*C) no more than 3 months.All reagents * andPACs must be atassay temperature (19 to 28 C)prior to use. Ifrefrigerated, allowto sit at assay temperaturea minimum of 30 minutesprior to use.
Note: The BufferSolution precipitates at 4*C. Allow the solutionto come to room temperatureand thenagitate the bottle for 10 to 15 secondsto dissolveany precipitate.
INDICATIONSOF INSTABILITY
Indicationsofpossible reagent deterioration notedat the end of testing are: a colorlessPositive Control a NegativeControl with a bluecolor
SAMPLECOLLECTION, STORAGE AND PREPARATION
SampleCollection
Samplecollection isa criticalstep. Personnel collecting vaginal fluid specimens should be welltrained to minimizethe possibility ofinadequate specimens. Directions forsample collection areincluded inthe container holdingthe Affirm'VP Sample Collection Sets. All samples must be collectedusing the materials (swabs and tubes)provided inthe kit.
Separateswabs should be usedfor other tests, e.g. culture ormicroscopic slide samples.
Affirm' Specimenscollected andprocessed bythe SampleCollection Setcan not be used for culture.
CAUTION: DURING THE COLLECTIONAND PROCESSING OF SPECIMENS,USERS ARE ADVISEDTO OBSERVE ALL SAFETY PRECAUTIONSAPPROPRIATE TO HANDLINGOR DISPOSINGOF POTENTIALLY INFECTIOUSMATERIAL.
SampleStorage and Transportation
Swabsshould be placed into the sample collection tubes provided inthe Affirm' VP SampleCollection Set(See directionsincluded with the sets). The total time between placing the swab into the sample collection tubeand proceedingwith the sample preparation should be no longerthan 60 minutesifthe sample is stored at room * temperatureor4 hoursif the sample is stored at 2 to8 C.
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PROCEDURE
Note:READ ALL INSTRUCTIONSCAREFULLY BEFORE PROCEEDING.(See Figure 2)
GeneralNotes
Affirm' The VPiiiMicrobial Identification Testcontains sufficient reagents toperform the assay an 24 vaginal samples.Each PAC containsone Positive and Negative Control that serve -as quality control checks for test reagentsineach Reagent Cassette. Each sample requires a Reagent Cassette and PAC andthe processor to Affirm' performthe Test. The Testmay be performedon 1 to6 samplessimultaneously. The Processoris requiredfor automated sample processing. Thetest procedure isshown in Figure 2.
SamplePreparation
Affirm' (Requires LysisHeating Block) (See Figure 2) Samplepreparation includes mixing the swab with the Lysis Solution, heating and adding Buffer Solution sothat thesample is ready to test. The specific steps are described below.
Verifythat the Lysis Block is at 85 _+ 5*C andthat reagents are at room temperature and well mixed.
2. Uncapthe sample collection tube, making sure the swab shaft is firmly seated in the cap. Add 12 drops(0.3 ml) of LysisSolution. The dropper bottle should be vertical when addingdrops.
3. Holdingthe cap, mix the swab in the tube by swirling ortwisting and moving the swab in an up and downmotion against the side of the tube for at least 10 seconds.
4. Re-capthe tube to prevent evaporation. Theswab will remain in the tube.
5. Insertthe tube into a wellof the Lysis Block to heat.
6. Incubatethe tube in the Lysis Block for 10 minutes(at least 10 minutes,but not longer than 20 minutes).
7. Removethe tube from the Lysis Block.
8. Add 12 drops(0.45 ml) of Buffer Solution tothe tube containing theswab. Avoidtouching the tip ofthe bottle.
9. Snapthe cap tightly on the tube and mix by flickingthetube briskly 10times.
Note:Specimens may be storedat roomtemperature at thispoint for up to 24 hours.
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10. To proceedwith automatedprocessing of the preparedsample, remove as muchfluid as possible from theswab by liftingthe swababove the fluidlevel and pressing the swab firmly against the side of the tubefor at least10 seconds.Dispose of swabsin a biohazardcontainer. Press a FilterTip firmly ontoeach Sample Collection Tube.
AutomatedProcessing
(RequiresAffirm' Processor)
Note: Beforeproceeding, ensure that all reagentsare at assaytemperature, 19 to 28*C. Affirm' Affirm' If the VP111Microbial Identification Test ProgramCard is not alreadyin the Processor,insert the ProgramCard, printed side up, arrowpointing towards the instrument, into the slot locatedon the front rightside of the instrument.MAKE SURE THAT THE PROCESSOR 13OFF WHENINSERTING THE PROGRAM CARD. THERESHOULD BE NO LIGHTSON THE CONTROL PANELIF THEPROCESSOR 13OFF. "home" 2. TURNON THEPROCESSOR. The Processor arm will moveto duringthis initialstep. As youmove through the procedure,follow the promptsan the ProcessorDisplay. If additionalhelp is needed,press the [HELP]button.
3. Removethe CassetteCaddy from the Processor. It is easierto addthe samples with the Caddyoff theProcessor.
4. Selectone Reagent Cassette foreach sample to be tested. Identify thesample an the front end of theReagent Cassette with a permanentmarking pen, if desired. Carefully pullthe foil covering off ofthe Cassette, starting atthe end labeled "LIFT", and place the Cassette inthe Caddy. When placingtheReagent Cassettes onthe Cassette Caddy, balance the number of cassettes oneach side ofthe arm as evenly as possible andload from the center tothe sides.
5. Openthe top of the pouch containing thePAC, but do not remove the PAC from the pouch. Avoid touchingthebeads. Place desired identification on thePAC inthe space provided.
6. Pressthe [RUN] button. You will be instructedto"Add Substrate". Add4 drops(0.06 ml) of SubstrateSolution towell #7 ofthe Reagent Cassette.
7. Pressthe [RUN] button. You will be instructed to"Add Sample".Be carefultomatch up each SampleCollection TubelFilter Tipwith the corresponding labeled PAC and Reagent Cassette. Invert theSample Collection tubeand firmly squeeze the entire contents ofeach tube through the Filter Tip intowell #1 ofthe appropriate Reagent Cassette. Foam at the filter tipis a goodindication that theentire sample has been delivered.
8. Placethe CassetteCaddy onto the Processor.
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9. Pressthe [RUN]button. Youwill beinstructed to "PlacePAC". Placea labeledPAC into well #1 of eachReagent Cassette.
10. Pressthe [RUN]button again.The arm of the Processorwill start forward. TheProcessor will pick andmove the PACs throughthe test procedure.The instrument will begin automatically up 32:50" the processingtime sequenceand will indicate"Please wait... Processing with minutes remainingon the timerindicated. At the endof the processingtime, the instrumentwill beepand presentthe PACfor removal.
11 Removethe PACand gently blot dry with a papertowel. Interpretthe resultsof the test for each specimen.The PAC should be viewed against a whitebackground, under normal intensity lighting.
Note:Make sure any PACis removedfrom the Processorbefore pressing the RUNbutton to start a secondrun.
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in
12 Drops Lysis, 12 Drops Buffer Solution Solution and Mix and Mix
(Followprompts on AffiirMTM ProcessorDisplay)
Place PAC Well 1 Place Filter MOR&M dr-04ft Tip AffirWYA# Add a06M Start and 4 Drops Processor Add Sample Substrate 32:50 LysateWell 1 Solution Minutes Well 7 + 000001
Reagent Cassette Well: 1 2 3 4 5 6 7
POSITIVE NEGATIVE Test is VALID if 0400 0 Positive Control = Blue Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118= Any BLUE COLOR NO COLOR Colodess_ Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
RESULTS
Resultsare determined bythe presence orabsence ofblue color on the PAC test bead. The presence ofany visiblebluecolor on the target organism bead is a positiveresult. Theabsence ofany visible blue color an the targetorganism bead is a negativeresult.
A positivetest result indicates thepresence oftarget organism nucleic acid as listed below in Table 2. Ifa positivetestresult isaccompanied byappropriate clinical signsand symptoms, the associated clinical conditions areindicated. Simultaneous infections bymore than one organism are common.
Table2
ResultsInterpretation
AssociatedClinical Result NucleicAcid ClinicalCondition Signs and Symptoms
Candida Candidaspecies Yeastvaginitis Pruritis, discharge, irritation, dysparunia
Trichomonas Trichomonasvaginalis Trichomoniasis Yellow,frothy, orpurulent discharge, odor,pruritis, increasedvaginal pH
Gardnerella Gardnerellavaginalis Bacterial vaginosis Increasedvaginal pH, amine odor, thinhomogenous adherent cells" discharge,"clue
104 Negativeresults from Candida, Trichomonas, orGardnerella testsindicate lessthan 1 X Candidacells, 5 X 10'trichomonads, or2 X 10' CFU Gardnerella vaginalis organisms, respectively, presentin the patient sample. Negativeresults forthe Candida, Trichomonas, orGardnerella testsare suggestive thatthe patient does not have candiasis,trichomoniasis, orbacterial vaginosis, respectively, ifconsistent withthe associated clinical signsand symptoms.
QualityControl
TheAffirm' VP111 Microbial Identification Testincludes a Positive Control bead and a NegativeControl bead on eachPAC. Thesecontrol beads are tested simultaneously witheach patient specimen, ensuring the proper performanceofreagent, reagent cassette, andprocessor. Thecapture probes onthe Positive Control bead form specifichybrids with color development probes inReagent Cassette well 2. ThePositive Control probes have hybridizationcharacteristics similarto the target nucleic acid complex. The Positive Control ensures proper performanceofthe test and the absence ofspecimen interference. Probesan the Negative Control beads do nothybridize toany nucleic acids present inclinical specimens norto the biotinylated colordevelopment probes.
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The NegativeControl also ensures the properperformance of the test andabsence of non-specificbinding from the specimen.
In a properlyfunctioning test, the PositiveControl bead should be blue andthe NegativeControl bead should be colorlessafter processing.If the PositiveControl does not turn blue andlorthe NegativeControl does not stay colorless,the test resultsare invalidand patientresults should not be reported.
If the PositiveControl doesnot turn blue, checkthe expirationdate of the reagentsand checkthe additionof substrateto well 7. If the NegativeControl does not remaincolorless, check the expirationdate of the reagents and specimenprocessing.
With eachtest run, verify that roomtemperature is between19 and 28*C, andthat the lysis heatingblock is at 85 + 5*C.
Eachreagent lot may be tested for adequatesample lysis andrelease of target nucleicacid usinga swabstreak of indicatorculturp, e.g., Candida a0cans (ATCC18804). SinceTrichomolws vaginalis and Gardnerella vaginalis lysesmore readily than Candida species, it is onlynecessary to test Candidaspecies for adequatesample lysis. If all patientsample results are consistently negative, the specimen lysis stop should be checkedwith a control strain. If the targetbead for the controlorganism tested does not turn blue after processing,the test results areinvalid and patient results should not be reported.
LIMITATIONSOF THE PROCEDURE
Affirm' The assayis intendedto be usedwith the VP SampleCollection Set. Othermethods of collectionhave not been evaluated.
Optimaltest resultsrequire appropriate specimen collection. Test results may be affectedby improper specimencollection, handling and/or storage conditions. A negativetest resultdoes not excludethe possibilityof vaginitisivaginasis.
Specimensheld longerthan 1 hourat roomtemperature or 4 hoursat 2 to 8*C priorto specimen preparationmay cause false results. Prepared specimens held longer than 24 hoursat roomtemperature priorto specimenprocessing may give inaccurate results.
A positiveresult for Candidameans Candida species nucleic acid is presentin the specimenand indicates the patienthas yeastvaginitis if consistentwith otherclinical signs and symptoms.
104 A negativeresult for Candidameans Candida species nucleic acid of lessthan 1 X Candidacells are presentin the patientspecimen. A negativeresult for Candida(yeast) suggests that the patientdoes not haveyeast vaginitis if consistentwith otherclinical signs and symptoms.
A positiveresult for Trichomonasmeans Trichomonas vaginalis nucleic acid is presentin the specimen andindicates the patienthas trichomoniasis if consistent with otherclinical signs and symptoms.
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10' A negativeresult for Trichomonasmeans Trichomonas vaginalis nucleic acid of less than 5 x trichomonadsare present in the patientspecimen. A negativeresult for Trichomonassuggests that the patientdoes not have trichomoniasis if consistent with otherclinical signs and symptoms.
A positiveresult for Gardnerellameans Gardnerella vaginalis nucloic acid is presentin the specimenand is suggestiveof bacterialvaginosis in the patientif consistentwith otherclinical signs and symptoms, suchas pH >4.5, aminoodor, thin homogenous adherent vaginal discharge, and clue cells. 2x105 A negativeresult for Gardnerellaindicates less than CFUof Gardner.-Ilavaginalis are presentin the patientspecimen. A negativeresult for G. vaginalisis suggestivethat the patientdoes not have bacterialvaginosis if consistentwith otherclinical signs and symptoms.
The Affirm' Viii MicrobialIdentification Test detectsthe presenceof Gardnerellavaginalis at concentrationsof greater than 2xl 05 CFUper assay. The diagnosticvalue of thislevel of detectionis notdefinitive.
The presenceor absenceof Gardnerellavaginalis although suggestive, is not diagnosticfor bacterial vaginosis.As in manyclinical situations, diagnosis should not be basedon the resultsof a single laboratorytest. Results should be interpretedinconjunction with other clinical and laboratory data availabletothe clinician suchas pH,amine odor, clue cells, and vaginal discharge characteristics.
Women withvaginal discharge should be evaluated forrisk factors ofcervicitis andpelvic inflammatory disease,and if present, evaluated for other organisms, including gonorrhea and chlamydia.
Vaginitisismost frequently caused by yeast, Nchomonas vaginalis andGardnerella vaginalis. Vaginitis symptomsmay alsobe seenin toxic shock syndrome (caused by Staphylococcusaureus] or may be causedby non-specific factors orby specificorganisms. Mixed infections may occur. Therefore, a test indicatingthepresence ofCandida species, Gardnerella vaginalis, andlor Trichomonas vaginalis does not ruleout the presence of otherorganism, including Mobiluncus muliefis, Mycoplasma hominis, and/or Prevotellabivia.
Cryptococcusneoformans atconcentrations greaater than 1 x 1 Do yeastiml react with the Affirm" Viii MicrobialIdentification Testfor Candida species. C.neoformans isonly rarely encountered inthe vagina. 410' Mohiluncusmulieris atconcentrations greater than bacterialmland Bifidohacterium dendum at 8x1O5 Affirm' concentrationsgreater than bacterialmlmay react non-specifically withthe VNi Microbial IdentificationTestfor Gardnerella vaginalis. B.dendum is rarely encountered inthe vagina.
TheAffirm' VNi MicrobialIdentification Testmethod has been used with vaginal fluid specimens from patientswith symptoms of vaginitis/vaginosis. Performance with other specimens or other patient populationshasnot been established.
The performanceofthis test on patientspecimens collected during or immediately after anti-microbial therapyis unknown. The presenceor absenceof Candidaspecies, Gardnerella vaginalis or 14 00e
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Trichomonasvaginalis can not be usedas a testfor therapeuticsuccess or failure.
Adulterationof reagents or failureto followinstructions exactly as set forthin the directionsfor use mayadversely affect performance asdescribed in the labeling.
EXPECTED VALUES
Independentinvestigators evaluated theAffirMTM Vp111 Microbial Identification Testfor Candida species, Gardnerella vaginalis,and7richomonas vaginalis invaginal samples. Specimens were from women presenting withsymptoms ofvaginitisivaginosis orfrom women considered athigh risk for infection.
Theinvestigators recorded the clinical signs and symptoms associated withvaginitis including theappearance andmicroscopic evaluation ofthe vaginal discharge andvaginal pH. Microscopic evaluation included thepresence ofclue cells, budding yeast or pseudohyphae, andmotile trichomonads. Amine odor after addition ofKOH was alsonoted. Based on theseresults theinvestigators recorded a diagnosis ofbacterial vaginosis, candidiasis, or Affirm'm trichomaniasis.A specimen was alsocollected andprocessed for analysis by the VNi Microbial IdentificationTest.In addition, theinvestigators collected specimens that were sent to the laboratory forculture isolationandidentification andpreparation ofa smear for analysis byGram stain.
InvestigatorsusedHBT, Sabarouds, andDiamond's media for culture ofGardnerella vaginalis, Candida species, andTrichomonas vaginialis, respectively. Culture results arepresented forcultures showing clinically significant growthonly, since culture identification ofGardnerella vaginalis and Candida specis isnot recommended in womenwithout vaginitis symptoms. Women withoutBV orcandidiasis may carry low levels ofG. vaginalis 105 orCandida species, respectively, whichis detectable by culture atapproximately a level > cfufor G. 104 vaginalis,orof > yeast forCandida species, perml vaginal fluid.
Candidaspecies
Table2 presentsthenumber of patients positive byeach method for Candida species identification. A totalof 740women were examined for Candida species (yeast) identification byall the methods except for Gram stain (n=484).Approximately 15% of patients samples were positive foryeast by theAffirm Viii Test, by culture isolationata clinically significant level.Twelve percent ofthe samples were positive byKOH wetmount. An additional26 samples were identified aspositive onlyby wet mount; however, they were negative byculture AffirmTm (nogrowth on Sabouraud's)andby two independent ViiiTests. Fifteen ofthese apparent positive sampleshad a Gram-stainedsmear prepared from the same swab as the wet mount which were read by the lab supervisorandfound to be negative. Smears were not available forthe remaining 11samples. Six percent of thesamples were identified by Gram stain evaluation fromseparate swabs.
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Table3 Resultsof ThreeMethods of Identificationfor Candidaspecies
MicroscopicEvaluation Affirm" Clinically VP111 Significant Positive Culture Result (n=740) Positive Wet Mount Gramstain
Positive Positive L> 104cfulml) (n=740) (n=484) (n=740)
Apparent Ill 31 109 Positives' % 15% 6% 15% 15% Confirmed 85 31 ill 89 Positives % 12% 6% 15% 12%
'A totalof26 samples were identified aspositive onlyby wet mount but negative byculture (nogrowth onSabouraud's) andby two independentAffirm'VPiii Tests. For15 of these 26apparent positive samples aGram-stained smearprepared fromthe same swab asthe wet mount was read by the lab supervisor andwere found tobe negative. Randomly readGram-stained culturewere positive smearswhich were positive byeither Affirm' orby Gram stain. Smears were not available forthe remaining 11samples. Confirmedpositives arepresented inthe lower position ofthe table.
Bacterialvaginosis
AlthoughG.vaginalis wasoriginally thought tobe the only etiological agentof BV, it is now believedtobe a morecomplex disease. Not only is G. vaginalis present, butother anaerobic bacteria such as Bacteroides and otherspecies are involved. Thesyndrome involves a relative shiftaway from a vaginalecology dominated by Lactobacillustoone dominated byG. vaginalis andanaerobic bacteria. G.vaginalis, whilenot the sole etiologic agentof bacterial vaginosis, remains one of the major causes for this condition andis the primary bacteria cells'7 observedadhering tothe surface ofclue . Thepresence ofG. vaginalis, inthe absence ofclinical signs andsymptoms, isnot diagnostic ofBV .
Thestandard method for the diagnosis ofBV isthe presence ofthree of the following fourcriteria: a vaginal dischargethatis white, non-floccular andadherent tothe walls ofthe vagina, butis not markedly increased over normalamounts; the release ofan amine odor from the vaginal fluid after the addition of10% KOHto a sample; a vaginalpH of greater than 4.5; and the presence ofclue cells onexamination ofthe vaginal sample under the
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lightmicroscop8.Z18 BV;" In the past,culture of G. vaginalishas been used as a diagnostictool for however,there are multiple organismspresent in womenwith symptoms of BVand studies have shown that G. vaginalisis presentin vaginosis.' asymptomaticwomen and women successfully treated for bacterial Therefore,culture of lowlevels 105 Gardnerellavaginalis isnot recommended asa method of diagnosingBV.2 Highlevels of G.vaginalis (> cfu perml of vaginalfluid) has been correlated with BV." Affirem Fourindependent investigators evaluated the abilityof the MicroProbe VNi MicrobialIdentification Test to identifyGardnerella vaginalis in vaginal samples. The study sites included three sexually transmitted disease clinicsand one public health, family-planning clinic. Specimens were from women presenting with symptoms of vaginitisivaginosis,or from women at highrisk forinfection. Table 4 presentsthe results of threemethods of identificationfor G. vaginalis.
Theair-dried smears were Gram stained with crystal violet and iodine and counter-stained withsafranin. Gram stainedsmears from samples that werediscrepant were read at onesite byan expertreader. Results were providedboth as to thepresence orabsence of Gardnerellamorphotypes aswell as scored for overall bacterial vaginosisflora. TheBV flora scoring system classifies vaginal flora into three categories; one dominated by normalLactobacillus (NL;score < 4), a transitional,or intermediate flora (INT; score 4 to 6),and a BVflora (BV; score>6) dominatedby G. vaginalisand other anaerobic bacteria such as Mobiluneasmuliaris with a correspondinglackof Lactobacillus.
A totalof 299 patients were evaluated for BV; of these,43% (129) were positive, based on 3 of 4 clinicalsigns andsymptoms. Table 4 presentsthe results of fourmethods of identificationof G. vaginalisin patientswith andwithout BV.
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Table 4 Results of Four Methods of Identification of G. vaginaUs in Patients with and without Clinically DiagnosedBV
Affirm Grainstain Grainstain Culture Positive Morphotype Interpretation Positive Positive BVb > 101CFUc All patientstested 171 200 152 168 (n=299) 57% 67% 51% 56%
Results in 118 123 113 107 Patients with 91% 95% 88% 83% Clinically Diagnosed BV by 3 of 4 Criteria
Results in 53 77 39 61 Patients without 31% 45% 23% 36% Clinically Diagnosed BV
b a115 Gram stainedsmears scored for Gardnerellamorphotypes. Gram stainedsmears scored accordingto Nugent et for BV flora; > 7 ' BV flora. Gardnerellavaginalis cultures showing moderate to heavy growthat clinicallysignificant levels.
Mixed Infections and BV
Mixed infectionspresent a challengefor the clinician. The datain a subsetof 289 patientsin this clinicalstudy was collectedby havingthe attending clinician provide diagnoses of bacterial vaginosis,candidiasis, and trichomonasis based on vaginaldischarge, pH, amineodor, andwet mount results. For BV this includesthree of the followingfour criteria:thin homogeneous adherentdischarge, pH > 4.5, cluecells, and amine odor. The recordedresults were reviewed by the principalinvestigator, who alsodetermined a BV diagnosisbased on the resultsof these sameevaluations. The overallsensitivity of the attendingphysician to reporta diagnosisof BV using3 of 4 clinicalsigns and symptoms was 75% (89/118). In womenwho hadno othercause for their vaginalsymptoms except BV, the sensitivitywas 82 % (79/96). However, in patients who had mixedinfections, ie candidiasisor trichomoniasisin additionto BV, the sensitivityof the attendingphysician to diagnoseBV was 45 % (10/22). Attendingclinicians had a greater difficulty in diagnosingBV in the presenceof mixed infections,where the sensitivityof their initial diagnosiswas 45 %, as comparedto singleinfections, where the sensitivityof their initial diagnosiswas 82 %. The diagnosisof BV wasunder-reported in patientswith mixed infections.
The results of three methodsfor G. vaginalisidentification, the Affirm' VP Microbial IdentificationTests, microscopicexamination, and culturalmethods, in patientsstratified by
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clinical diagnosesare presentedin which all test methodswere available (n=289) in Table 5. Microscopic evaluationfor G. vaginaUsconsisted of Gramstained smears evaluated by a scoring systemevaluating BV flora and by Gardnerellamorphotypes only; for T. vaginalisit was by evaluationof a wet mountpreparation for motiletrichomonads. The BV flora scoringsystem classifiesvaginal flora into three categories;one dominatedby normal lactobacillus(NL), a transitional,or intermediateflora (DM, anda BV flora (BV) dominatedby G. vaginaUsand other anaerobicbacteria such as Mobiluncus muliefis with a correspondinglack of lactobacillus. Observationof motiletrichomonads are requiredfor a clinicaldiagnosis of trichomoniasis.
Table 5 Results of Three Test Methods in Patients Stratified by Clinical Diagnoses
No. of Clinical Diagnosis Affirm Gram Stain Culture Patient Trichomoniasis Morph- s BV CandidiaS Tv BV BV Gv Tv is (Wet Gv + otypes Mount) INT
0 + + + 7 + + 6 1 7 7 7 6 0 15 + + 12 14 11 13 15 14 12 0 + + 11 + 5 9 5 8 8 8 9 33 + 7 0 2 8 12 17 01
96 + 91 1 5 83 1 90 1 90 93 11 1 - - - 127 I 1 40 2 29 50 56 65 3
299 Total (26) 161 31 137 176 198 203 357 a For G. vaginalisthe microscopicevaluation was basedon a Gram staininter-pretation score (score >3 and <7= intermediate (INT) flora, >7= BV flora (BV)) or Gardnerella morphotypes;for T vaginalisit was basedon wet mount results.
Ttichomonasvaginalis Affirm' Five independentinvestigators evaluated the ability of the MicroProbe VNi Microbial IdentificationTest to identify Tfichomonasvaginalis in vaginalsamples. Study sites included four sexuallytransmitted disease clinics and one public health, family-planningclinic. Specimenswere from womenpresenting with symptomsof vaginitis/vaginosis,or from women at high risk for vaginalinfection.
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The investigators recorded the clinical signs and symptoms including the appearanceof the vaginal discharge. In addition, saline wet mounts of vaginal secretionswere examined immediately after collection for motile trichomonads. A single motile trichomonadobserved under high power magnification (400 X) was sufficient for a positive result. Swab specimens were inoculated into modified Diamond's medium or, at one lab, Trichosel medium, and wet mounts observed for motile trichomonads for up to five or sevendays. microscopically daily Affirm'm A specimen was also collected and processedfor analysis by the VPIII Microbial Identification Test.
Table 6 showsthe total numberof specimens,the number of individuals tested, and the number and percentageof patientsdiagnosed with trichomoniasis at each site by eachmethod.
Table 6 Results of Three Methods of Identification for T. vaginalis
Clinically Significant Result Wet Afrwin- VPm Culture Mount All positives Positivein _:!ý_3 days T. vaginalis 98 104 106 = (n 851) 1 11.5% 12.2% 13.0% 12.5%
PERFORMANCECHARACTERISTICS
Independentinvestigators evaluated the AffirMTM Viii MicrobialIdentification Test invaginal samples. Specimens werefrom women presenting with symptoms of vaginitis/vaginosis or from women at highrisk for infection.
Candidaspecies Affirm4 Thesensitivity and specificity of the VI'mMicrobial Identification Test for Candidaspecies were establishedby comparison to conventional microscopy methods and to culture.The performance of the Affirm VP.Microbial Identification Test for Candidaspecies was determined in 740 patients. The performance of the Affirm'Vin Testfor Candida species and microscopy was evaluated in 479 women who presented with clinical signsand symptoms of yeastvaginitis and in 261 high-riskwomen who were evaluated for some other reason, includingpregnancy (n= 186),f amilyplanning, orbecause they are contacts of STD-positivepatients. A clinically 10' significantlevel of yeastculture isolation (> cfuper ml vaginal fluid) was used as the comparative method, sincethis level has beenshown, in the literature,to be associatedwith yeastvaginitis. Asymptornatic colonizationat low levelsof yeastis common.', 21 Raw performancedata are displayedin Table 7, and reconciledperformance data, after discrepant analysis by an independentmethod, are displayed in Table 8.
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Table 7 UnreconciledPerformance of the AffirMTMVPm Microbial Identification Test, Wet MountAnalvsis. and Gram stain to CultureIdentification of Candidaspecies
TestlCulture +1+ Sensitivity Specificity Accuray (TP) (FP) (FN) (TN) N 1%) N
Allpatients (n=740) Affirm'm 85 26 24 605 78 95.9 93
Wet Mount 59 52 50 579 54 91.8 86
GramStain (n-484) 25 6 35 418 42 98.6 92
Forpatients with presenting symptoms of Vaginitis (n=479) Affirm"' 65 20 17 377 79 95.0 92
Wet Mount 55 44 27 353 67 88.9 85
GramStain (n=329) 1 23 1 4 31 1 271 43 1 98.5 89 for patientswithout presenting symptoms of Vaginitis (n=261) Affirem 20 6 7 228 74 97.4 95
etMount 4 8 23 226 15 96.6 88
Gram Stain(N - 155) 2 2 4 147 33 98.7 96
Incases of apparent false positive results where the Affirm' Pin was positiveand the comparative result was Affirm" negative,alternate methods were used to confirm the Vi'mresult. For example in Table 7, there were Affirm" positive" 85 resultswhich were positive by both culture and by VI'mand 26 "apparentfalse samples Affirm' whichwere positive by VI'mand negativeby culture.These samples were examined for wet mount identificationofyeast. As seenin Table 8, 15 ofthese samples were also wet mountpositive. Inthose cases wherethe apparent false positives were confirmed bythe alternate method, the samples were moved to the true positivecategory and the reconciled sensitivity andspecificity recalculated andpresented inTable 8. Similarly, theAffirm' Pw Testwas usedto reconcile wet mount"apparent false positive samples". Gram stain was not usedto reconcile apparent false positives by wet mount because ithad lower sensitivity inthis study. Of the 10' remaining11 apparentfalse positive samples, 10 werepositive byculture, but at levels less than cfulml, andthe eleventh sample was alsopositive ina duplicateswab in a secondAffirm" Um MicrobialIdentification Testfor Candida species.
The performanceofthe AffirW Pin Test compared to clinically significant culture aspresented inTable 8. The sensitivityandspecificity was 81% and98.2%, respectively, ascompared to a sensitivityandspecificity of60% and94.0%, respectively, forwet mountand of 44% and99.3% by Gramstain, respectively, foridentification ofyeast in all women. The Affirm' Viii Test is more sensitive than either wet mount or Gram stain identification ofyeast and at clinically relevant levels.
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Clinical PerformanceStratified By Initial PresentingVaginal Complaint
Additionally,the performanceof these tests was alsoevaluated on the basisof whetherthe womenentered the clinic with a complaintof vaginitis,or if they were consideredat high risk of vaginitisand were beingseen for = someother reason, including pregnancy (n 186),family planning,or becausethey werecontacts of STD-positive patients. The majorityof womenin this trial had clinicalsigns and symptoms of vaginitis(640 of 740). AffirMTm The Test providedmore objectivedetection of clinically significantlevels of yeast. There was a differencein diagnosticperformance by wet mountbased on whetheror not the patientsentered the clinicwith symptomsof vaginitisor whetherthe visit originatedfor someother reason.Gram stain evaluation was a less sensitivemethod of detectingyeast.
As seenin Table8 for identificationof yeast,in womenwho enteredthe cliniccomplaining of vaginalsymptoms, the relativesensitivity and specificity of the Affirn-r Mn Test was 82% and98.4%, as comparedto 72% and Affirem 92.2%,respectively, for wet mount.These results indicate the two tests, ffiii andWet mount,perform similarlyin womenwho enter the clinic complainingof vaginitis. Gramstain identificationof yeast was less sensitivethan the othermethods, with a sensitivityand specificityof 46% and 99.6%,respectively.
However,in womenwho enteredthe clinic for some otherreason, the two tests did not performsimilarly. Of these 261 women,88% were eitherpregnant or hadsigns or symptomsof vaginitisrecorded during the office Affirm' visit. As seen in Table8, the relativesensitivity and specificityof the Test was 75% and 97.9%, respectively.The sensitivityand specificitywas 18% and 97.0%,respectively, for wet mountand was 33% and 98.7% for GramStain, respectively,for identificationof yeast.
The sensitivity of the wet mount evaluationwas apparently influencedby whether or not the women enteredthe clinic complainingof a vaginal infection (respectively);or whether they were seenfor some AffirMTm other reason (72% vs 18%, respectively).The sensitivity of the Test was not influenced by whether or not the women entered the clinic complainingof a vaginal infection or whether they were seen for some other reason (82% vs 75%, respectively). Since the reference method, clinically significant culture, remaindedthe same in both cases,this data suggestswet mount is more subjective and operator sensitive. Since it is well documentedthat symptomsare not well correlated with yeast vaginitiso, the Affirm"m Mu Test represents an objective measure of significant levels of Affirm"m clinically yeast in vaginal fluid specimens.The Test results are available at the time of the office visit. A diagnosis of yeast vaginitis requires the presenceof associated clinical signs and symptoms in addition to demonstration of the organism.
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Table8 ReconciledPerformance of the Affirrd' VPiii MicrobialIdentification Test, Wet MountAnalysis, andGram stain to CultureIdentification of Candidaspecies Testvs Culture +1+ +I- Sensitivity Specificity Accuracy (TP) (FP) (FN) (TN) N N N Allpatients (n=740) AffirmTm 100 ill, 24 605 81 98.2 95 WetMount 74 3r 50 579 60 94.0 88 = 99.3 92 GramStain (n 484) _ 1 28 1 3 35 418 44 Forpatients with presenting symptoms of Vaginitis (n=479) AffirmTM 79 6 17 377 82 98.4 95 WetMount 69 30 27 353 72 92.2 88
GramStain (n=329) 26 1 1 31 271 46 99.6 90 - orpatients without presenting symptoms of Vaginitis (N=261) '_ AffirrWm 21 5 7 228 75 97.9 95 WetMount 5 7 23 226 18 97.0 89 GramStain (N= 155) 2 2 4 147 33 98.7 96 ' 10of 11 ýaMD IBSwere oosit ive bv culture. buta t < 10'Yeast oer ml. The e leventh samDle was Dositive bva duDlicate Affirm. Mu Test. 1 11of 37 samples were positive byculture, butat levels < 10' yeast per ml. Of the remaining 26,1 was positive bya duplicate AffirmTMTest, 15of 15 were negative ona duplicate smearmade from the same swab as the wet mount
Gardnerellavaqinafis Affirm' Fourindependent investigators evaluated theability ofthe MicroProbe ViiiMicrobial Identification Test toidentify Gardnerella vagina#s invaginal samples. The studysites included three sexually transmitted disease clinicsandone public health, family-planning clinic.Specimens were from women presenting withsymptoms of vaginitisivaginosisorfrom women at high risk for infection. Affirm' Thesensitivity andspecificity ofthe VI'mMicrobial Identification Testfor Gardnerella vaginalis was establishedby comparison to conventional microscopy methods and to culturein299 patients.Culture determinationofGardnerella vaginalis isnot recommended forthe diagnosis ofbacterial vaginosis dueto the high numberof women positive forGardnerella vaginalis whodo not have clinical bacterial vaginosis. Because ofthis,
23
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Affirrnrm 10' ml." the Test was comparedto clinicallysignificant levels of G. vaginalis,identified as > cfuper AffirmTm The performanceof the Viii MicrobialIdentification Test for Gardnerellavaginalis as comparedto standardreference methods is presentedin Table9.
Table9 UnreconciledPerformance of Methodfor Gardnerellavaginafis Identification
Affirm" Comparison VIReferenceMethod Sensitivity Specificity Agreement
+1+ + 1. -1+ + (TP) (FP) (FN) (TN) ForGardneralla vaginalis, all patients(n-299) AffirMTMvs Gram 167 4 33 95 84% 96% 88% stainMorphotypes
Affiremvs Culture 147 24 21 107 88% 82% 85% > 2+
ForGardnerella vaginalis, inpatients with clinical BV by 3 of4 Criteria(n=129) Affiremvs Gram 117 1 6 5 95% 83% 95% stain Morphotypes; firMT1 Af VS Culture 105 13 2 9 98% 41% 88% > 2+
AffirmTm As withthe Testfor Candida species, theapparent false positive samples which were positive bythe AffirMTm but negativeby thereference method were evaluatedby the alternatereference method. For Gardne-rellavaginalis, when Gram stain morphotypes was thereference the discrepant samples were examined by cultureand when the reference method was culture,thediscrepant samples were evaluated by Gram stain morphology.For cluecells the discrepantsamples were alsoexamined by Gram stainmorphotypes for AffirMTM reconciliation.Thepercent agreement between the results obtained by the VP MicrobialIdentification Testsand currentreference methods is less than theup to 15% swabto swab variationseen in other Affirem methods.The results are presented inTable 10. Whenevaluated inall women, the Testwas both sensitiveandspecific as compared to the identification ofG. vaginalis by either Gram stain morphology orby clinicallysignificant culture levels. The relative sensitivity andspecificity ascompared to Gram stain morphology AffirmTm was 84% and100%, respectively. Whenthe Testwas comparedto clinically significant culture levels, AffirMTM the VPIIITest had a sensitivityandspecificity of 89% and99%, respectively.
24 /00000,
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Table 10 AffirMT" ReconciledPerformance of the Vp1j, MicrobialIdentification Test for Gardnerellavaginalis Affirm' Agreement Reference VPIReferenceMethod I Relative Relative Method Sensitivity Specificity + I (TP) FP) (FN) (TN) ForGardnerella vaginalis, allpatients (n= 299) Affirm'vs 171 0 33 95 84% 100% 89% Gramstain Morphotypes Affirm'mvs: 170 1 21 107 89% 99% 93%la Culture> 2+
ForGardnerella vaginalis, inpatients with clinical BV by 3 of4 Criteria(n= 129) Gramstain 118 0 6 5 95% 100% 95% Morphotypes AffirmT'vs 118 0 2 9 98% 100% 98% Culture> 2 + I I I I I I
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Trichemonasvaginalis AffirrnTm The sensitivityand specificityof the VP MicrobialIdentification Test for Trichomonasvaginalis were established by comparisonto conventionalmicroscopy method and to culture in 852 patients. The raw performancedata for the conventionalvaginal fluid sample obtained by dacronswab is presentedin Table11.
Table I I UnreconciledPerformance of the AffirMTMVp MicrobialIdentification Test for Trichomonasvaginalis Affirm" ReferenceMethod VP/ReferenceMethod Sensitivity Specificity Agreement +1+ (TP) (FP) (FN) (TN) SWABSAMPLE (n = 852) Affirmvs; Wet Mount 90 14 8 739 92 98 97
Affirmvs Culture, 99 5 12 735 89 99.0 98 all days
Affirmvs Culture, 97 7 9 738 92 99.0 98 _!!:-I.-3 days I I I I I Wet Mountvs 91 7 20 733 82 99.0 97 Culture,all days
AffirmTm AffirMTM As with the Testfor Candidaspecies, the apparentfalse positive samples which were positive by the Test for Trichomonasvaginalis but negative by the referencemethod were evaluated by the alternatereference method. positive" In thosecases where the "apparentfalse resultwas confirmedas positiveby the alternatereference method, the samplewas considered a true positive and the reconciledsensitivity recalculated. The reconciled performance is presented AffirMTM in Table 12. The relativesensitivity and specificity of the Vp111Microbial Identification Test for Trichomonas vaginalisis 93% and99.9%, respectively, as comparedto wet mountidentification of T vaginalis.Compared to a 5 to AffirrnTm 7 day Diamond'sculture, the relativesensitivity and specificity of the Test are 90% and 99.9%respectively. Sincemuch of the Diamond'sculture available is for a 48 to 72 hourincubation, the sensitivityand specificity was Affirm' calculatedusing this as the referencestandard also. The relativesensitivity and specificity of the Viii Microbial IdentificationTest as comparedto 48 to 72 hourDiamond's culture identification of Trichomonasvaginalis was 92% and AffirmTm 99.9%,respectively. In thisclinical evaluation, the VPIIIMicrobial Identification Test was comparablein sensitivity to 5-7 dayculture isolation of Trichomonasvaginalis.
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Table 12 Affirm" ReconciledPerformance of the VPw Microbial Identification Test for Trichomonasvayinafts
Reference Test /ReferenceMethod Relative Relative Agreement Method Sensitivity Specificity % +J+ % % (TP) FP) (FN) (TN)
SWABSAMPLE (n - 852)
AffirMTMVS Wet 103 1 8 739 93 99.9 99 Mount
AffirMTMVS 103 1 12 735 90 99.9 99 Culture,all days AffirMTM VS 102 1 9 738 92 99.7 99 Culture,< 3 days
Wet Mountvs 95 3 20 733 83 99.6 97 Culture,all days
VaginalWash Sample Collection
In onelaboratory, an alternatespecimen collection method was alsoevaluated in 106 patients.At this site,an additional samplewas obtainedby instilling3 ml of sterilesaline into the vaginaas a vaginalwash. Thesolution was retrieved and transferedinto the Sample Collection Tube. Once received at the laborabory,0.3 ml of the vaginalwash was removed and examinedby conventionalwet mountanalysis for motiletrichomonad. The SampleCollection Tube containing the vaginal AffirmTm washsample was centrifuged, and the supernant decanted. The sensitivity and specificity of the ffiii Microbial IdentificationTest for Trichomonasvaginalis using a vaginalwash sample was 87% (47155)and 98% (51152)vs 5-7 day cultureisolation of T. vaginalisusing Diamond's medium. The one apparent false positive by the AffirmTMTest was also positiveby wet mount,giving a reconciledsensitivity and specificity of 87% (48155)and 100%(51151), respectively.
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NOWCLINICAL RESULTS
A totalof 88 isolatesrepresenting 34 differentgenera of microorganismsidentified by Isenbergat. al asclinically relevant tract24 AffirMTM to thegenitourinary weretested in the WiiiMicrobial Identification Test as shownin Table13.
Table 13 VaginalFlora and Other Organisms Tested for Specificitywith AffirMT*VPoilYlicrobial Identification Test
Organism Number Organism Number Acinatobactersp. 1 tisteriamonocytogenos 1 Actinomycessp. 1 Mobiluncusspp. 3 Bacteroidesspp. 4 Mycobacteriumsp. I Branhame#8sp. 1 Mycoplasmahaminis 1 ffifidobacteriumsp. 1 Neisseriaspp. 2 Campylobactersp. 1 Neisseriagonorrhoeae 1 Candidaspp. 16 Paptococcussp. 1 Chlamydiatrachomatis 2 Paptostraptococcusspp. 3 Clostridiumspp. 2 Prevotellaspp. 2 Corynebacteriumspp. 1 Porphyromonassp. 1 Cryptococcusneoformans 1 Propionibacteriumsp. 1 Entamoebasp. 1 Pseudomonassp. 1 Enterobacteriaceae 5 Staphylococcusspp. 3 Enterococcussp. 1 Straptococcusspp. 3 Fusobacteriumsp. 1 Trichomonasvaginalis 9 Gardnerellavaginalis 10 Ureaplasmaurealyticum 1 Haemophilusducreyt 1 PeNonellasp. I Lactobacillusspp. 3 Other 1
Allof the organisms, except Cryptococcus neoformans andCandida species, were nonreactive inthe Affirm" Wii Microbial IdentificationTestfor Candida species ata concentrationof108 bacteria per ml.
Allof the organisms, except Mobiluncus mulieris, Bifidobacterium dantium, and Gardnerella vaginalis werenonreactive in theAffire' Wit Microbial Identification Testfor Gardnerella vaginalis ata concentration of 10' bacteriairrd. Mobilyncus 4x1O' 8x1O5 mulieriswasnonreactive ata concentration of bacterialml,andBifidobacterium dentiumwas non-reactive at bacterialml.Bifidobacterium dentiumis only very rarely recovered from the vagina. Most Bifidobacteriuln sp.and strains ofB. dentium are recovered from body sites other than the vagina orurogenital tract.
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AffirmT'j All of the organisms,except Trichomonas vaginalis were nonreactive in the WiiiMicrobial Identification Test for Trichomonasvaginilis at a concentrationof 10' bacterialmi.
ANALYTICALSENSITIVITY
Affirem 10' The VPiiiMicrobial Identification Test for Candida species can detect 1 x cfuof Cal7didaspecies inlog phase 10' perassay, for Gardnerellavaginalis can detect 2 x cfu of G. vaginalisin log phase per assay, and for Trichomonas vaginaliscan detect 5 x 10' trichomonadsperassay.
INTERFERINGSUBSTANCES
In clinicalstudies, no evidence of interference was detected for vaginal lubricants, douches, menses, or spermicides.
REPRODUCIBILITY AffirMTM The Systemwas evaluated at threetypical clinics by threedifferent first time users (nurse practitioners) for reproducibilitywithin and between runs. Each site evaluated twenty-four coded samples consisting of twelve positive and twelvenegative samples. Four runs of sixsamples per run were performed at each site. Completeagreement of results Affirm' wasobtained on every sample by eachof thethree sites, demonstrating thereproducibility andease of useof the Systemwithin and between runs, and between sites.
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REFERENCES
1. Kent, HL.Epidemiology of vaginitis.Am J ObstetGynecol; 165 (4 Pt 2) p1168-76;Oct 1991.
2. Vulvovaginitis.1989. ACOGTechnical Bulletin. American College of Obstetriciansand Gynecologists.
3. GravettMG, HPNelson, T DeRouen,at al. 1986. J Am Med Assoc256: 1899-1903.
4. FaroS. 1991. J ReprodMad 34:602-604.
5. GravettMG, D Hummel,DA Eschenbach,at al. 1986. ObstotGynecol 67:229-237.
6. McGregorJA, JI French,K Sao. 1991. Am J Obstet Gynecol165:867-875.
7. McGregorJA, JI French,R Richter,at al.1990. Am J Obst Gynecol163:1465-1473.
8. Sobel,JD. Vaginalinfections in adult women.Mod Clin North Am; 74 (6) p1573-602;Nov 1990.
9. SobelJ. Vaginalinfections in adult women.Med Clin North Am; 74 (6) p1573-602, Nov 1990.
10. KriegerJN. 1981. Urologicaspects of trichomoniasis.Invest Urol 18:411-417.
11. Rain MF. 1990. Trichomanasvaginalis. In: Principlesand Practiceof InfectiousDiseases, 3rd ad. MandellGL, RG Douglas,Jr, and JE Bennett (ads).Now York: ChurchillLivingstone Inc., p.2115-2118.
12. SpiegelCA. 1991. Chapter6: Vaginitis- Trichomonasvaginalis vaginitis, yeast vaginitis, bacterial vaginosis,isolation and identificationof Gardnerellavaginalis. In: LaboratoryMethods for the Diagnosisof SexuallyTransmitted Diseases, 2nd ad, WentworthBB, FN Judson, MJR Gilchrist (ads). Am PubHealth Assoc. p. 182-185.
13. HillierSL andKK Holmes.1990. Chapter47:,Bacterial Vaginosisl In: SexuallyTransmitted Diseases, 2nd ad. HolmesKK, Mardh,,P-A, Sparling PF, and WiesnerPJ (ads).San Francisco:McGraw-Hill InformationServices Company, p. 547-559.
14. SobelJK. MadClin North Am 1990;74(6): 1573-602.
15. Nugent,RP, MA Krohnand SL Hillier. 1991. Reliabilityof DiagnosingBacterial Vaginosis is Improved by a StandardizedMethod of GramStain Interpretation. J Clin Micro 29:297-301.
16. Spiegel,CA, R Amse,and KK Holmes. 1983. Diagnosisof BacterialVaginosis By DirectGram Stain of VaginalFluid. J ClinMicro 18:170-177.
17. HillierSL, MA Krohn,RP Nugent,and RS Gibbs.1992. Characteristicsof three Vaginal flora patterns assessedby Gramstain among pregnant women. Am J ObstatGynecol 166:938-44.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
18. McGregorJA, JI French,K Seo. 1991. Adjunctiveclindamycin therapy for pre-termlabor: Results of a double-blind,placebo-controlled trial. Am J ObstetGynecol 165:867-875.
19. McGregorJA, JI French,R Richter,et al. 1990. Cervicovaginalmicroflora and pregnancyoutcome: Resultsof a double-blind,placebo-controlled trial of erythromycintreatment. Am J ObstetGynecol 163:1580-1591.
20. MartiusJ, MA Krohn,SL Hillier,at al. 1988. Relationshipsof vaginalLactobacillus species, cervical Chlamydiatrachomatis, and bacterial vaginosis to pre-termbirth. Obstet Gynecol 71:89-95.
21. MortonK, L Regan,S Springe,and E Houang.1990. A furtherlook at infectionat the time of therapeuticabortion. Eur J ObstetGynecol Reprod Biol 37:231-236.
22. SoperDE, FICBump, and WG Hurt. 1990. Bacterialvaginosis and trichomoniasis vaginitis are risk factorsfor cuff cellulitisafter abdominalhysterectomy. Am J ObstetGynecol 163:1016-23.
23. HammondTIL, GD Hankins,and FIR Snyder. 1990. Transvaginalperitoneal migration of Tricholnonas vaginalisas a causeof ascites:A reportof two cases.J ReprodMed 35:179-181.
24. Isenberg,Henry D., andRichard F. D'Amato. 1991. Indigenousand pathogenic microorganisms of humans.Manual of ClinicalMicrobiology, 5th ed., Ballows,Hausler, Herrmann, Isenberg, Shadomy (ed.),ASM, Washington, DC, p.8.
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AffirmlvViii MicrobialIdentification Test for Candidaspecies, Gardnerella vaginalis, and rrichomonas vaginalis CatalogNo. 805228 To OrderAffirMTm Test Kits Call MicroProbe Corpation or Authorized Distributor. Askfor yourCustomer Service Representive (800)800-4714 (USA) or (714)894-7184 Telefax:(714) 891-1229 between 8:00 am and 5:00 pm PST ForTechnical Assistance Call MicroProbe Corporation or Authorized Distributor Askfor yourTechnical Service Representives: (800)447-4362 (USA) or (206) 485-8566 Telefax:206-486-8336 MicroProbeCorporation Bothell,WA 98021 USA Copyright1992 PatentsPending PartNo. RL-0160.00 March 1992
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
oftlwlslýmci"Vva w w
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VP III, PAC, ART FOR GRAVURE PLATE RL-01I 1-00
M...P,&. C.. 8,*,1. WAW021 UU AftWVPHi T*si
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ACTUAL SIZE ART
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SHOWN 2X COLOR: Teal PMS 322
comer radius = 3/16"
AffirnfVPiii MicrobialIdentification Test
PROBEANALYSIS CARD
--L
0) FORIN MTRODtAGNOSTIC USE.
Lot:
Exp.
Store at 2 to 8 C MicroProbeCorporation, Bothell,WA 98021 U.S.A. SC-0059-00 RL-0112-00
0)
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 LABEL, REAGENT CASSETTE, VP111 RL-0107-00
ACTUAL SIZE COLOR: PMS
1/8" comer radius =
'AffkwfVPx Identillicai Mir.robial M ýýý I FOR IN VITRO DIAGNOSTICUSE.
Lot Exp: Store at 2 to474, 8 C MaoProbe CorporWan. SoMd, WA SM21 U.SA SC4060-00 IIL-010740 7 1
3-6"
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 (q w--- - ý
Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 LABEL, VIAL, LYSIS SOLUTION, VPIII RL-0108-00
SHOWN 2X comer radius = 3/16" COLOR: Blue PMS 285
Microbial Identification (A'ffirrnfmVPmTest LYSISSOLUTION FOR INVITRO DIAGNOSTIC USE. Vol,9.5 M 15/16" Lot: 8
Exp: Storeat 2 to8 C -j 0) 0 ",:ýM ýr.Pwb. ýCWr.ýfi.., Btýh.IIWA ý9802'1U ýAS
1 15/16"
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 LABEL, VIAL, BUFFER SOLUTION, VPIII RL-0109-00
SHOWN 2X COLOR: Green PMS 339
comer radius = 3/16"
Imim Microbial *Aff VPm Test Identification
9911y, R ANN 15/16" FOR INVITRO DIAGNOSTIC USE. Vol,15 ml Lot:
Exp: Storeat 2 to8 C
MicroProbeCorporation, Bothell,WA 98021 USA.
1 15/16"
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 LABEL, VIAL/POUCH, SUBSTRATE SOLUTION, VP RL-0110-00
SHOWN 2X COLOR: Red PMS 185
corner radius = 3/16"
Microbial 'ý-' Identification biý CAffftnemVPm6Test
FOR IN VITRO DIAGNOSTICUSE. Vol. 3.4ml 15/16" Lot:
Exp: Storeat 2 to 8 C C? (06 IX j/ MicroProbeCorporabon. Bothell, WA 9MS021 U.S.A.
1 15/16"
J(pý' Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 RecordsLABEL, processed under BAG, FOIA # 2016-3957; FILTER Released by CDRHTIPS, on 11-22-2016VP RL-0084-00 REV. A, DRF 1037
3/16' SHOWN 2X, corner radiLs= COLOR: black on white
00000 TM Wrob4al ; IdentIficcition A VpTee FILTER TIPS 16' Contents:24 FitterTips 15/ Store at 2 to 30 C FOR IN VITRO DIAGNOSTIC USE. Lot: ina: MicroProbeCorý,ýtion, Bothell, WA 98021U.S.A. --'11 1 15/168
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 RecordsLABEL, processed underSPECIMEN FOIA # 2016-3957; Released byTUBE, CDRH on 11-22-2016VP RL-0092-00 REV. A, DRF 1039
SHOWN 2X COLOR: BLACK ON WHITE
comer radiLn= 1/8'
NAME
DATE CY IM
11ME
1.59
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 to Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
GOO-Svw-la 00-99w-os ,Y,s,nIZO96 VM'1104102 luoilojodio:) eqOldOJOIV4 i0l 'ojj!Aul enbitsouftip96esninOd -0oIRto Z aijus seineq 17 op snld jetuesuoo sed ou uouis 'ps mb aineq ,I suep uOjjqueqOqI op luewalneil ne JOP?DOJd 3ssnobu -asnoilsouftip ojj!A ul joi -uoijejedaid eldwes ajolgq O.S-Z le sinOLI v ueqj jo6uol ou ojols jo uolloolloo jo inoq auo uiql!m uoijejedaid eldwes LIPM P90301d 13S N011331103 3ldWVS
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
ys'n tom 0 Imto.lo P- - saum" UOOnvols Pei V = 0ldO"Otn I#OWOVQN3 NOIWO*3 Nn MUNOI UNOOIA"am pwjomdAmWY J V J21490alou IAR103 T SOVU*Nsp )Q'OVv4-"- pa8ewepunpouadou" %A W4 m 13 Ww'"OL. &-VV60A P- AN-0206-IN LUOIS o8elood QVRIS I SVMS 03ddli:Nokiova3ýO SNIVINOO -y's'n tog 133d yo 'SAOJDUGpjeq pe". is Uaw Uouseep"a ue ivals eciOJdOJ-,! "Oklova"a 001WO03 NAAWALNOO Oo'dA ,u . W WV 4m Wksoo-ou 'Ag-03 1 S-VUA%op Padro 13 4vps-.q- p- W-12-6- (I Pots o8iqmdWnjeptm pouodomtR wms xmývwl, I-lv"Nl 400 C13ddll:NOH3VO 3NO SNIVINOO avms 133d
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 LABEL, BOX, VPIII RL=0114=00
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
SECTIONIV
CLIAComplexity
AffirMTMVp111 Microbial Identification Test for CanAvdaspecies, Gardnerella vaginalis, and TrichemonasVaginalts
vp Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
REOUESTFOR TEST CATEGORIZATION: LEVEL1, MODERATECOMPLEXITY
AffirrnTm VPiii Microbial Identification Test for Candidaspecies, Gardnerella vagin8lis, and WChOMOM ftk8h
Affirm' MicroProbeCorporation requests that the VP MicrobialIdentificiation Test for Candidaspecies, Gardnerellavaginalis, and Trichomonas Vaginalis be categorizedas a Level1, ModerateComplexity test as definedin theFederal Register 57(40):7002-7288, February 28, 1992. Thisspecific request is madeconsistent with theguidelines at page 7017, and by 42 CFR493.17, using the same seven criteria as follows:
Knowledge(Score 2) - Analystneeds little, if anyinformation additional to step-by-step directions to properlyperform the procedure and report results.
2. Trainingand Experience (Score 2) - Trainingspecific for theprocedure is all that is required.
3. Reagentsand MaterialsPreparation (Score 1) - Minimalpreparation (reagents pro-packaged or promeasured).
4. Characteristicsof Operational Steps (Score 1) - Fewsteps, automatic specimen processing and timing of proceduralsteps, limited function checks, built-in calibration, and minimal or nocalculation required.
5. Characteristicsof Calibration, Quality Control and Proficiency Testing Materials (Score 1) - Calibration andcontrol materials readily available, stable and easily incorporated into the procedure. Proficiency testingmaterials, when available, are stable.
6. TroubleshootingandMaintenance (Score 1) - Minimaloperator intervention required.
7. Interpretationand Judgement (Score 2) - Minimalrequired.
Thetotal score for these seven criteria is 10,and scores twelve or lessare categorized asmoderate complexity. Also,we believethat the Affire Viii MicrobialIdentification Test for Candidaspecks, Gardnerella vaginalis, andTrichomonas Vaginalis is aseasy to performas othermoderate complexity tests for microbial diagnostics, TestPack' SureCeIlTm e.g.Abbott's StropA or Kodak's sandwichimmmunoassays, andmuch easier to perform thanGen-Probe's PACE DNA probe assays which include multiple steps, including extensive reagent preparation andprecise temperature control in contrastto theAffirm' Viii Test.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 ww___ ýI
Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
SECTIONV
References
Affirm'mVI'm Microbial Identification Testfor Candida species, Gardi7erella vaykafls, andTrichommas VagZaalis
143 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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/0
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Copyright material .. vaalnffis1,1116 and ,
Preanancy 0
Sebastian Faro,M.D., Ph.D. -The
f
la
amoxica-
,
b .
Vaginitisinpregnant women can qftct the outcome ofthe r. prirgnannithrough preterm labor, premature rupture of themembranes, chorioamnionitis, neonatalhVwtion and k postpartumendome&u1s. Women ornbe screened for groupB streptococci,and infiectwn inthe newborn can beprevented by the institution ofantibiotic therapy in WOmanv labor.Screening pregnant women for liacterial vaginiti . can reducethe risk of premature rupture ofthe prematurelabor and neonatal inftction. mem-br rs
. .
Fromthe Depament of Obstetrics andGynecology, BaylorC& -eof Modkirm Houston. Texa& repnntrequests to:Sebastian Fara.NLDý Ph.D. 63% tis -Am SbjetýSuite 7M. Houston, TX77M 0024-7M/$9/340$-MWSL50/00 Mie jotirnal ofReproductive Medicine, Itir. 602 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118Medicirt! Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Pages 150 through 151 redacted for the following reasons: ------Copyright material
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-v4;-"IndependentAssociations of Bacterial ý-;iVaginosisand Chlamydia trachomatis -i":;tn,,t-ion-W-11th-Ad Pregnancy___ .1'.Ou"come ouen,';rhr' G. Gr2vett, MD: H. PrestonNelson. IMC;'7imothy Dep Oft.low. MS; David A. Eschenbach,MD; King K. Holmes, MO, PhD
Copyright material ýie' relat; Ji.. presoectiveq studied the "CnS hip-cf pregnancy outcorne to bacterial an anaerobic vaginal ccneitiion. and to other selected genital 7ýýýý7--5:3---g-av;d-womenr-Za(:teri;-mLuagiaasiZ. was gresumotivel y ;nc. used ga&-IiquidchýqrnaLoqrachicidentific2tion ofmicrobial organic ,a by- L :-"4taC_*ites in 102 women (19%), -and Chlamyd,*z found in 47 (9%) of the women. Although-obstetrir_:.fac' women with and 4*!-'ýNfthoutt-ac:enil v-ad'F6ýý-6icrsimilar-demographic -and- Monates torn to women with bacterial vaginosis had lower mean birth weight #an c5d neonates born to women without bacterial vaginosis (2960t_947 g vs 3184 7 5 8 g). Bacterial vaginosi3 was significarittly 1 associated with p reterm mature rupture of the membranes (odds ratio JORI. 2.0; 95% confidence int"! 1. 1 to 3.73, preterm labor (CR, 2.0. Cl, 1. 1 to 3.5), and amniotic k-ection (OR, 2.7; Cl. 1. 1 to S. 1). but not with birth weight below 2500 g 1.5, C1, 0.8 to 2.0). Cervical infection with C trachomads was k4ePendently associated with preterm premature rupture of the membranes,.. ----Pretermlabor . and low birth weight (OR , . 1.5; Cl, 0.8 to 2.0). (JrAMA19SSZ&19?9-IS
Copyright material
I -ft*40.
,t 444A.Oca 10. Mr,--Vol 256.M. 14 ACIVOMPreqUMVy 0UiC0M--&Sv0a of at 1899 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Pages 153 through 156 redacted for the following reasons: ------Copyright material
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7.1 6 :'P# .,g--i-Tre term Iabor Associated1,*1ith Subclinical A Trmotic Fluid Infection ar.i With Bacterial _yaoo-nosis
EL G. GRAVETI,T MD, DEBORAH HLMMAEL, RN, DAVID A. ESCHEIVEACH,NO, 'AND KLVG K. HObVES, MD, PhD
Copyright material -enital infection.particularly subdinical amniotic fluid ....mdon, mav causepretenn labor and a prematur The prevalenceof subciinicalamniatic fluid deliverv.wai- stdclied consecutive&febrile women infec it pretermlabor with singletongestations and intactfeta membranes.Microorganisms were recovered from the fluidbv transabdominalamniocentesis in13 (24%) amriiof 54 patients.Bacteria or Candidaaibiarns were recovered from six and genitalmycoplismas from seven (137c Comparedwith women withsterile imniotic fluid. oatien _4':. whoseimniotic fluid contained bacteria orCandid;
(0.5versus 34.3 davs, P < .01),were less resvonsi organ
morefrequently developed subsequent intravartum feve fluidcontained genital rnvcoclasm2s didnot diffe hose in theseparameters from thosewith sterile fluid. Also comoaredwas cervical-vaginalinfection among these inpreterm labor with matched pa- oretermtabor. In thisanalysis, bacterialcontrol*subject vaginosis was id-n"ifiedin ý43% of patientswith and 1.11'aof women s WIMautpreterm labor (P = .02),yielding a relative risk of pretermlabor for patients with bacterial vaginosis of 3.3 :ýrv Thesedata underscore the importanceof amnicticflui bacterialinfectiorts inpreterm; labor and premature deliver and suggestthat bacterial vaginosis isassociated with (o&srerGýunecol $7.21-9, 19SQ prt- din
Copyright material
Fnwf113e OrPOrt"motJ 0f Obstetrics andGiptcMoV, arfit.Vedi hi*tious:DM'V.V. 11"immity 'ofwasifiyývtorlSeattl inPtIrt. 11YP4,16utwi histitutes ofHeuttis ratoirdi grant tion.
OL. 67..40.1. FEMUARY 19" Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118L3 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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Copyright material
--ansvaginal-T,-;e'r*tonealMigrration Trichomonas yaginalis as a Causeof Ascites Reportof TwoCases
Terry L. Hammond, NC, USAY -MaýLt ol Gary D. V. Hankins, MC, USAF Mai RusseU FL Snyder, MC, USAY
y
Genitaltract colonization with Trichomonasvaginalis usuaiiyresults in vaginitiswithout systemic 77tereare only four recorded cases of Trichomonas maniýýsta-t Moveredfrom pelvicorgans or peritonealfluid. This n5wrtdescribes two additionalwomen in whommotile idgellateorganisms were recovered from abdominopelvic 'ýCites.We hypothesizethat an ascendingtrichomonal e i4ectionmay have played an etiologicrole in the of theiracute disease. develop-M h
numthe Department ofObstetrics andGynecology, Wilford Ha Addressreprint requests to:Mai Terry L Hammond,NC, USAF, -11itedStates Air Force Medical Center, Lackland Air Force Base, DepartmentofObstetrics and Gynecology, Wilford H&U United -ftas. StatesAir Force Medical Centez Lackland Air Force Base, TX /&4j -1111W. 614iHammond isObstetrics and NursePractitioner. Gynecology The expressedherein are those of the authors and not ýtC01 opinions HankinsisChairman and Program Director. necessarilythose ofthe United States Air Force orthe Department Aaris Chief, Gynecology Service. ofDefense. -M4-,ý58/90/35M-0179/S1-W/0It The Jourrial of ReproductiveMedicine, Inc. 179 Ounudof ReproductiveMedicine 114 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Characteristicsof three vaoinal flora patternsassessed by
Gram stain among,4 pregnant women
PhD,, PhD,', PhD,, Sharon L Hillier, Maxiiane A. Krohn, Robert P. Nugent, and MD.1 Ronald S. Gibbs, for the Vaginal laections and Prematurity Study Group Seattle,Washington, Bethesda. Maryland, and Denver,Colar;ado
Thisstudy was undertakento definethe characteristicsand persistenceof vaginalflora in 7918pregnant weeks' womenat 23 to 26 gestation.Vaginal smears were categorizedas normal(predominant lactobacilli),intermediate (reduced lactobacilli), or positivefor bacterial vaginosis. The womenwith normal florawere least likely to haveelevated vaginal pH, aminoodor, milky discharge. or colonizatioriby Gardnerefia,Bacteroides, or genitalmycoplasmas. Women with intermediate vaginal flora had Intermediatefrequencies of these clinical signs and mic=rganisms.Cvoup 8 streptococciand yeast wereassociated with normal or intermediateflora. whereas Neissede gononficeas and Chlamydia trachomadswere recoveredmore frequently from women with intermediate flora of bacterialvagino". Thchomonasvaginalls was most associated with intermediate flora. At foflow-up,81% of thewomen with normalflora had remainednormal. Of the womenwirth intermediate Rom 32%acquired bacterial vaginosis and 30%shifted to normalflora. Only 12% of the womenwith bacterial vaginosis had shifted to normal flora.We concludethat there are two primary stable vaginal flora patterns (normal flora or bacterial vaginosis)and a thirdless distinct transitional flora pattern between these two. (Am J OBSTErGYNECOL 1992;166:938-44.)
Key words: Bacterial vaginosis,vaginal flora Copyright material Copyright material
ci
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CriecoloV, Epidemiol. from tit D"rrmenu ofOkutrics and and dwNational lnsdtuký Child Htakh ogy"University e W"rm of le and Humn Devekpmewand Ae Departmentof Obsterriaand Grwo&S7,Uniumay ý(Colorado Hea4h Soma Center'Memberr ctive of theVaginal Infectums and Prematuruy Study Group and thew affiS"m arelisted a( theend of the artLcle. Supportedbyconawt;HD-3-2832, HD-3-2833, HD-3-2834, HD-3-2836.and Al-4-2532 from OwNa4onal Insts" HD-3-28 of Ck& Healthand HwaanDemiopmenc and A, MabonalImahat of AUerI7and Wtedous Dimaw. Receitwdfor pub&,ationAprd 10. 1991;rarvited Auria 26, 1991; o"epW Auewl23, 1991. Reprintrequesis: Sham L HiMer,?AD, University of Washirigton, Department Obstetricand GrecaloV,RH-k. Seattle,WA of al 98195. 611133421 rns
038
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D16[;P6[;6 69COND 9DITICN
Editors Kng K. Holmes,M.D., Ph.D. Diret.ror,University of WashingtonCenter for AIDSand STD, Universityof Washington.Scardr. Washington Per-AndersMlr8h, M.D., Ph.D. Professor.Institute of Clinicai Microbioiusy,University of Uppsala.Uppsala, S%vedcn P. FrederickSparling, M.D. Chairmanof the Depirtmentof Mcdicine,1. HerbertSize Professorof Microbiologyanti Immunologyind .1ifedicine.University oi North C.;rolinaSchool oi Medicine,Chapel Hill. North Carolin.1 PaulJ. Wiesner,M.D. Direttor. DcKilb Counn.Health Department.Detarur, Georgia
Associate Willard Cates,Jr., M.D., M.P-H. Editors Director, Divisionof ScxuallvTransmitted Discases. Cenrcr-5 "or DiseaseControl. Atlanta.Ceorgia Stanley %I. Lemon, M.D. Chicf. Divisionof Inf"-6ous Disczsts.Profts-f oi.Medicineand Microbiuiorgy and Immunology.p Univcrsiry of North CarohniS%:hool of Mcdicinc,Chapel F41. North Carolina Walter E. Stamm,M.D. Professorof Mcdicinc.Hc-id. InfectiousDiscaso Division. HarborvievvMcdical Ccnter. Scitfle. Wabhinzon g
McGraw-HillInformation Services Company HEALTH PROFESSIONS DIVISION
New York Sc. Louis San Francisco Colorado Springs Auckland Bogoci Caracas Hamburg Lisbon 1undon Madrid I'vlexico I'viiian Montreal New Delhi Paris San Juan Sio Paulo Singapore Sydney Tokyo Toronto
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SEXUALLY TRANSN11ITTED DISEASES
Copyright C 1990. 1984 by McGraw-Hill. Inc. All rights reserved.Printed in the United Statesof America. Except as permittedunder the UnitedStates Copyright Act, of 1976. no part of this publication may be reproducedor distributedin any form or by any meuns. or stored in a data baseor retrieval system.without the prior wniten permissionof the publisher. 1234567890HALHAL a9432109 ISBN 0-07-029677-4
This book was setin Sabon Roman by Waldman Graphics.Inc.: the editors were Avii McCracken and PeterMcCurdy: the production supervisor was Bob Laffl(!r-. thecover desiener and colorinsert designer was Edward R. Schultheis. HallidayLithograph Corporation was printerand binder.
Libraryof CongressCataloging in Publication Data Sexuallytransmitted diseases. Includesbibliogr3phies andindex. 1. Sexuallytransmitted diseases. 1. Holmes. King K. JDNLA 1.Sexually Transmitted Diseases. WC 140S51741 RC200.S49 1990 616.95'1 89-12,165 ISBN 0-07-029677-1
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40
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MANUAL OF CLINIaL !PY FIFTH EDITION
EDITOR IN, CHIEF ALBERT BALows
EmoryUniversity School of Medicine,Atlanta, GeOT&
EDITORS WILLLkM J. HAUSLER, JR. UniversityofIowa Hygienic Laboratory, Iowa City, Iowa KENNETH L. HERRmANN Centersfor Disease Control, Atlanta, Georgia HENRY D. ISENBERG LongIsland Jewish Medical Center, LongIsland Campus for Albert Einstein College of Medicine, New Hyde Park, New York H. JEAN SHADomy VirginiaCommonwealth University, Richmond, Virginia
AMERICAN SOCIETY FOR MICROBIOLOGY Washington,D.C.
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oooo* 6; Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118ki Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
0 Relationships of Vaginal Lactobacfilusspecies, CervicalChlamydia trachomatis, and Bacterial Vaginosis to PretermBirth
IOACHZM MARTIUS, MD, MARIJAIVEA. KROHN,PhD, SHARON L. H=ER, PhD, WALTERE. STAMM, MD, KING K. HOLMES,MD, PhD, AND DAVTD A. ESCHENBACH,MD
Copyright material infectionwas compared The frequencyof genital among 37 womenin prematurelabor who delivered preterm (before ,:b weeks),women in pretermlabor who delivered at term,and controlwomen who deliveredat term Both POUP3 Of reterm womenin prematurelabor wereyounger and had more previouspreterm births than did controlwomen. Women in prematurelabor who deliveredpreterm were more likely to experiencerupture of membranes,intrapartu= fever, and postpartumfever thanwen controlwomen. The presenceof gs bacterialvaginosis (odds ratio 27.33) and Chlarnydia ) (odds ratio 3.9) was positivelyassociated, tracho-mand Lactobacillusso (oddsratio 0.21 was negatively associated, with birth before37 weeks, using multivariable analysis to controlfor ccimfoundinSvaxiables. (Obstet Gynecol 777:359, 1988) ted
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V0E_71, NO. 1. JANUARY1988 ,7844".50 89 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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Adjunctive clindamycin therapyfor pretermlabor: Resultsof a double-blind, placebo-controlledtrial
James A. McGregor, MDCM, Janice L French, CNM, MS, and Ryunlg Seo, MD, PhD Denver, Colomdo
A double-blind.placew-controiled, randomizedtrial was conductedto evaluate the efficacy,Seely, and tolerance of a course of chMamycin (administeredfor 3 days intravenously" 4 days weeks' locolytim-orally)among hospitalizedwomen with preterm labor at s;34 gestationwho were treated with one hundred three woman-perinatepairs were analyzed. Univariate analysis demonstratedthat pregnancies were continuedlonger in women treatedwith chridamycinthan in women who receivedplacebo (clindamycin-tmatedgroup, 35 days; ptacebo-Veatedgroup. 25 days; p - 0.02). Survivalanalysis showed thm pregnancy continuedat least 35.S days in S01/6of clindamycin-treatedwomen versus 20 days for control women (P - 0.03). Obstetric and microbiologicparameters associated with treatmentoutoomes were also soughL Women with bacterial vagtnosismore often deliveredpreterm (P - 0.03; relative risk. 1.4; 95% confidence interval. 1.04 to 2.0). Among women with bacterialvaginosis. trends for increased duration of pregnancy (clindamycin-treatedgroup, 36 days: placebo-treatedgroup, 19 days), increased birth weight (ciindamyon-treatedgroup, 2634 gm: ptacebo-treatedgroup, 2256 gm). and increased mean gestational age at delivery(clindarriyan-treated group. 3S weeks, placebo-treatedgroup, 34 weeks) were associated with cfindamycintreatment. Women with either group B strepwcoccus, CN&rnydiatrachornads, Tdchomonas vaginafis. or Slaph)dococcuseureia were more likely to have preterm prematurerupture of membranes (p - 0.01). Crindamycintreatment of these women reduced the hricidenceof preterm premature ruptufe of memoranes to that of uninfectedsubjects. Stratificationby gestationalage at enrollment showed ciindamycintreatment to be associatedwith an increased interval to delivery only weeks' among mothers enrollea before 33 gestation(clindamytin-treated group. 40 cays;placebo-treated group, 28 clays;p < 0.05). Treatment with clindemycinaopeared safe and well tolerated.with benefits limited to women who were :s32 weeks'gestation. (Am J OesT.-, GYNEco-1991;165:867-75.)
7,ey words: Preierm labor, antibiotics, infection. bacterial vaginosis
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lled d Fro- d- Dep-ft--l of CUMirza -a q-ewkV. Uxft-siýy of Qiorade H*GMSCk%= Ce"or. SupperW 69 The Upjokn Cowp&M.Uannw. Mikkilest. Pruenwif ai theVmý AMual MeOmir of dwSOOM of PerinaW Obamidam, San Fmnaten. C41,fomid.Jansany 2846ruvy 2. 1991. '-print requou:Jamet A. McCrqw. MDCH. UCHSC.,Bax 8 198. 90 Eam NnUh Avg- Dýe7riwr.CO 30262. UZ800
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tenatal microbiologic and matemal risk factors associated ith prematurity
MDCM,* MS,I MSN,, its A. McGregor, Janice 1. French, CNM, Ruth Richter, CNM, MS,I MS,* PhD,' jWa Fraiico-Buff, Anne joh-nson, Sharon Hillier, MD," MD* altlyn N. Judson, and James IL Todd, jw, Colorado, and Seattle, Washi" miff-, I a prospective study of 202 women (gestational age 24 = 4 weeks), we evaluated possible influences of Wital tract infection or bacterial conditions on obstetric outcomes, including preterm labor, preterm P ,premature rupture of membranes, and preterm birth. The presence of bacterial vaginosis (18.70/6)was ted with an increased risk of preterm labor (relative risk. 2.6: 9S% confidence interval, 1.08 to :E-ý6.46).Z women with bacterial vaginosis who also had Mobiluncus species morphotypesidentified on Cram stain. the relative risk of pretermlabor was 3.8 (95% confidence interval. 1.32 to 11.5). Presence of vaginal Mycoplasma hominis (10.8% of patients)was associatedwith both preterm labor(relative risk, 1.8; -95% confidence interval. 0.77 to 4.4) and preterm birth (relativerisk, 5.1; 95% confidenceinterval, 1.45 to 17.9). Recovery of Staphylococcus aureus(3.00/6) was associatedwith prelerm labor(relative risk, 3.1; 95% confidence interval 1.12 to 8.7). Identificationof two or more bacterial-linked abnormalitieswas also associated with preterm labor (relative risk. 3.3; 95% confidenceinterval. 1 .44 to 7.58). An increasedlevel of vaginal wash protease (al 0 trypsinunits) (16%) was associatedwith preterm labor and was noted in 5004 of women with preterm prematurerupture of membranes.A history of prior prelermbirth was the shnie best historical predictor of both preterm labor (relativerisk, 3.6: 95% confidenceinterval, 1.92 to 6.83) and preterm birth (relative risk. 6.7; 95% confidenceinterval, 2.2 to 20.4). Historyof three or more abottons, antenatal urinary tract infection,and occurrenceof medical complicationsduring pregnancy also correlated with increased risk of preterm labor. These findingsaffirm and refine associationsof various matemal reproductive tract infectionswith preterm labor, prematurerupture of membranes.and binh, hallowingfor controlled treatment trials aimed al.preventionof preterm birth. (Am i OSST-tTGYNECOL 1990.163:1465-ý3.)
Key words: Prematurity, preterm birth, bacteria, infection, risks, pathogenesis
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FrOmt4t Department Obsteincsand Gynecolorr.UniversLft of Center,, Of ColoradoHealth ScLences Departmentof Obstetric University Washington,'Denver Department and'Gy-"ecoHeaiih HOSPiAah.' of of Departmevilof Medkine and FreventrwMedicine, Unftý of ColoradoHealth ScievicaCenter,' and Department Center., of U-vmriry of ColoradoHealth Scienc. &V'kW for Pblicaho. April 24. 1990; rmisedJ uly 2, 1990; CqWtdjU(y27, 1990. RePrintrequests: James A. McGregor,MDCM, Universityof Health SciowesCenter, Box B 198, 4200 E. 91h:Ave'. Denver. Colo-""do .090262 --611124146
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1-1 pregnancy' Cervicovaginalmicroflora and outcome: Results of a double-blind,placebo-controlled trial of erythromycin treatment
MDCM,* IUS,' N[SN,I jaxnes A. McGregor, Janice L French, CNIM, Ruth Richter, CNIA, BSN,4 BSN,I MD,* Margo Vuchetich, Vaundeen Bachus, Kyung See, PhD," NMI NID,I Sharon HMer, Franklyn N. Judson, John McFm PhD,4 MDI Judith Schoon-2ker, and Jamts IL Todd, Denver, Colorado, and SeauU, Washington
Available information suggests that some instances of preterin birth or premature rupture of membranes are associated With clinically unrecognized infection and inflammation of the lower uterine segment. decidua. and [eta) membranes. Various csrvicovaginal microorganisms have been recovered from these sites. Many of these microorganisms produce factors that may lead to weakening of the fetal membranes. release of prostaglandins, or both. This study evaluated the presence of various lower genital tract microflora and bacterial conditions in 229 women enrolled in a double-blind. pfacebo-controlled trial of short-course erythromycin treatment at 26 to 30 weeks' gestation to prevent preterm birth. Demographic, obstetric, and microbioiogicparameters were prospectivOyevaluated. Prematurerupture of membranes occuffed less frequently(p < 0.01) among women who received erythromycin(V1.) versusplaceoc (16%). Preterm prematurerupture of membranesalso occuffed less frequently,although not significantly (p - 0.3) in patients who receivederythromycin (20,16) versus placeco (5%). Erythromycintreatment significantlydecreased the occurrenceof prematurerupture of membranes amongwomen who were initiallypositive for aWamydla"chorneft infection.Logistic regression analysis demonstrated that C. 0'aChoMadS(p - 0.05; adds ratio, 9), vaginalWash pho$phorfpa$eC (P - 0.08: Oddsratio. 6) and prior preterm birth (p - 0.007; oddsratio 17) were associatedwith increasedrisk of precermbirth. eacterial vaginosis.Mycoplasma hominis, Ureaclasma urea"cum were not significantlyassociated with increased risk of preterm birthor preterm ruature of membranes.These findingssupport a role for selected lower genital tract microilorain pretermbirth and prematurerupture. Large controlledtreatment trials of specific infectionsor conditionsassociated with preterm birth and prematurerupture of membranesare required to confirmthe value of antimicrobialtreatments in preventionof microcial-associatedprelemn birth. (AmJ 09srEr GyNecoL1990;163.1580-91.)
words- Key Premacuricy, premature rupture of membranes. infection. ancibiocic. treatment. prevention
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From Ae Departmentof 06wiriz and CynecoloV,Vniueniq of C04wadoHea" scirft= Censer.,the Deparone"i O&VOwictand Mdi,*w,'*/ C)*#ea[jdV, UjdVý of W"ji" Sdwol of Dem, Prevrn:m-Publik Hea-UA and Hwpaa4; and As DepartmentOlUedignu "d Medkiw, Cala,ý HeaZASicnca Cauer.' Univerý of Harpual.' and At Depanvmvaof Pediatria.The Chiklim:i Ftwiwd for pubU=dan Manh 23, 1990;, rn4ud May 23. 1990; "Ced 1-.4 27, 19.90. Aqvri7a requou. laxuw A. McGrelm MDr-If, 4200 Z. 91AAve., odw &lye, Denver, 61ZI241JO
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EuropeanJournal of Obsietnes & Gynecology andReproductiEw Biology, 37 (1990) 231-236 231 Elsevier
EUROBSOD998
A furtherlook at infectionat the time of therapeuticabortion
* Karen Morton *, Lesley Regan *, Jane Spring and Mizabeth Houang DepartmentsofGynaccology andMicrobiology. Chelica Hatphal for Women,Dovehoute Street, London, UX Acceptedfor publication 13December 1989
SUMMMY
Microbiologicalinvestigations and clinical follow-up were performed on 516 patients undergoingfirst-trimester tern-tination of pregnancy,over a 2-year period. Chlamydia trachomanswas isolatedby pre-operativemicrobiological screening in 6.7% of patients,gonococcus in 0.4% and Trichomonayvaginalis in 2%. Candidaspp and Gardnerellavaginalis were isolated from 16% and 28% of the women, Patients who had positive cervicalchlamydial isolation were significantly respec-tively. younger(< 22 years)than thosewho did not. Doctor's clinical diagnosisof genital tract infection was found to be associatedwith a positive screeningresult but not with the likelihood of postabortalpelvic infection. Among the 175 patientsfollowed up in the outpatient clinic, 4 of the 15 patients with a positive result for N. gonorrhoeae,C trachomatisand/or T. vaginalisdeveloped postoperative pelvic infection, which is significantlymore than the group who did not harbour any of thesethree organisms(9/114). Infection,Thempeutic abortion; Abortion
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Presentaddresses: * Karen Morton, Department of Obstetrics& Gynaccology. St.71wmas Hospital. London,U.K. '0 LesleyRegan. Department of Obstetric3& Gynaccology. Addenbrooics Hospital. Cambridge,U.K- JaneSpring, Department of Obstetrics& Gynaccology, Farnbrough Hospital, Kent,UX Cor"upondence:Dr. E. Houang. Queen Charlotte's and Chelsea Hospital. Goldhawk Road. London W6, U.K-
0028-2243/90/SO3.500 1990 Elsevier Science Publishers B.V. (Biomedical Division)
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 4E Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 JOURNALOF CLINICALMicitoaiotoGy. Feb. 1991.p. 297 -301 Vol. 29, No. 2 0095-1137/911020297-05$02.00/0 Copyright (0 1991.American Society for Microbiology
Reliability of Diagnosing Bacterial Vaainosis..7 Is Improved by a StandardizedMethod of Gram Stain Interpretation NUGENV* ROBERT P. MARIJANE A. KROHN,2AND SHARON L. HILLIEW Pediatric, Adolescent,and Maternal AIDS Branch, National Institute of Child Health and Human Development, Executive Plaza North, Bethesda, Maryland 20892.' and Department Epidemiology2and Department GyneCojogy.3 of of Obstetrics and Universityof Washington,Seattle, Washington98195 Received27 April1990/AccepEed 22September 1990
The purposeof thestudy was to examineintercenter variability In theinterpretation of Gram-stainedvaginal smearsfrom pregnantwomen. The intercenterreliability of individualmorphotypes identified on the vaginal smear wasevaluated by comparingthem with thoseobtained at a standardcenter. A new scoringsystem that usesthe most reliablemorphotypes from the vaginalsmear was proposed for diagnosingbacterial vaginosis. This scoringsystem was compared with the Spiegelcriteria for diagnosingbacterial vaginosis.The scoring system (0 to 10) was described as a weighted combinationof the following morphotypes:lactobacilli, Gardnerellavaginalis or bacteroides(small gram-variablerods or gram-negativerods), and curved rods.By usingthe Spearmanrank correlationto determineintercenter variabffity, gram-positivegram-variablecoccii had poor agreement(0.23); factobadHi (0.65), G. vaginaLU(0.69), and bacteroides(0.57) had moderate agreement; and small (0.74) and curved(O.W gram-variablerods had good agreement.The reliabilityof the 0 to 10 scoringsystem was maximizedby not usiaggram-positivecocei. combining G. vagirý andbacteroides morphotypes, and weighting more heavily.curved gram-variablerods. For comparisonwith the Spiegel criteria, a scoreof 7 or higher was consideredindicative of bacterialvaginosis. The standardizedscore had improved intercenterreliability (r = 0.82) comparedwith the Spiegelcriteria (r = 0.61). Ile standardized score also facilitatesfuture research concerningbacterial vaginosisbecause it provides gradationsof the disturbanceof vaginalflora which may be associatedwith differentlevels of risk for pregnancycomplications.
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 CHAPTER 258 - TRICHOMONAS VACINAUS 2115 or. with Entamoeba histol.vacaand Ciardia iwestinalij in the Lagos population. 74. Gupta MC. Unutia JJ. Effect ofperiodic amiascarisand antigiardia treatment LaLj Epidemioi. 1977:6:231-4. on nutritionalstatus of preschoolchildren. Ara J Clio Nutr. 1982,36:7946. t R. Epidemiology and transmissionof Siardiasis.Trans R Soc Trop 73. Jokipii L. Jokipii AMM. Is predispositionto giardiasisassociated with the hq=0Htyg.1980-,74:433-6. ABO bloodgroups? Am I Trop Med Hyg. 1980;-'9:5-7. 'P, Dunlop TS. GaspardOB, et &I. Waterbornegiardiasis at a mountain 75a. Laughon BE. Diucianan DA. Vernon A, et &L Prevalenceof enteric path. ,,art.- Evidence for acquired immunity. Am J PublicHealth. ogensin homosexualmen with and without acquiredimmunodeficiency syn. 1984;74:602-4. drome. Gastroenterology.19U;"-.984-93. Smith PD, Gillin FD. Brown WR. et al. IgG antibody to Giardia lamblia 75b. JanofTEN. Smith PD, Blaser MJ. Acute antibodyresponses to GiardiaJam. dgected by enzyme-Linked immunosorbent assay. Gastroenterology. blia are depressedin patientswith AIDS. J Infect Dis. 1988;157:799-9%. 1095-7 1981.80:1476-80. 76. JokipiiAMM. Jokipii L. Ptepatency of giardiasis. Lancet. IV77; 1: . Njiovi PPG. Gilman RH. SantosharnM. et al. Age-re Wed rate of 77. Shaw RA. Stevens MA. The reactive arthritis of eardiasis. A cue report. of antibody to Giardia lamblia in four diverse populations.I semposi-tivityClin JAMA. 1997-X81734-4. 1986:24:972-5. Ml-crobiol.78. Wright SO. Giardiasis and mala sorption. Trans R Soc Trop Med Hys. EdsonCM. Farthing MIG. Thoricy-Lawson DA, et al. An WOMMI, Giardia 1980;74:436-7. jambda surface protein which is immunogenicin humans. Infect Immun. 79. SuttonDL, K-th KR. Giudiasis with protein losingentaropathy. J Pediatr GastroenterolNutr. 1985;4:56-9. 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Dig Dis. 1974-.19:791-6. samples,jejunal aspirate and jejunal mucosal impressionsmears in the V jl. TliompsoaA. Rowland R, Hecker R. et al. Immunoglobulia-bearingcells in ofSiardiasis. Ann Trop Med Parssitol. 1978.72.491-2. di-agnosis giardiasis.I Clin Pathol. 1977-,30:292-4. 83. Rosen" P, Liebman WM. Comparative study of stool exams, duodenal 31..Heyworth MF. Antibody responseto Giardia muris trophozoites in mouse aspiration. and pediatric Entero-Test for giardiasisin children. J Pediatr. intestine. Infect Immun. 1986,SL369-71. 1980ý96:273-9. 53. Snider DP. Underdowti BJ. Quantitative and temporal analysis of murine 94. Goka AKJ, RolstonDDK, Mathan VI. et al. Diagnosisofgiardiasis by specific antibodyresponse in serumand gut secretionsto infectionwith Giardiamuris. Ig.M antibodyenzyme-linked immunosorbentassay. Lancet. 1986;2:lU-6. Infect Immun. 1986;51=71-9. $5. Nash TE. Herrington DA. Levine IMM. Usefulnessof an enzyme-linked .54. Snider DP. Gordon J. N tcDermott.MR. et al. Chronic Giardia muris infection assay for detectionof Giardia antigenin feces.J Clin.1viicrobiol. im-munosorbent of anti-I&M-treatedmice. 1. Analysisof immumoglobdinand parasite-specific 1987,25:1169-71. antibody in normal and immunoglobulindeficient mice. I Immutiol. 1985; 86. Rosoff JD. Subbs HH. Isolation and identificationof a Giardia 134:4153-62. stoolantigen (GSA 65) useful in coprodiagnosisof giardiasis.lamblia-spe-cificI Clin 54a. Snider DP, Skea D. Underdown B1. Chronic giardiasisin B-cell-deficient 1996:23:905-10. Mj-crobioi. - Infec- mice expressingthe xid gene. Immun. 1988ý56:2339-41_ 87. Gordu B. Hemelhof W. Asselman C. et al. In vitro susceptibilitiesof 25 .55. Conley ME, Delacroix. DL. Incravascularand mucosal immunoglobulinA: Giardia lamblia isolatesof human origin to six commonlyused antiprotozoal - Two separate but related systemsof immune defense. Ann Intern Med. agents.Anumicrob Agents Chemother. 1985;ZU7940. 1987;106;992-9. 88. McIntvre P. Boreham PFL. Phillips RE, et al. Chemotherapyin giardiasis: 36. CarlsonJR. Heyworth MF, Owen RL. Responseof Peyer's patchlymphocyte Clinical responsesand in vitro drug sensitivity of human isolatesin axenic subsetsto Giardia muris infectionin BALB/c mice. Il. B-cell subsets:Entenc culture. J Pediatr. 1986:108:1009-10. anuien exposureis associatedwith itrununoglobu" isorypeswitching by 89. Inge PMG. Farthing MJG- A radiometricassay for aatigiardialdrugs. Trans patch B cells. Cell It=unol. 1996:97:51-8. Pey-er's R Soc Trop Med Hyg. 19ri-,91:345-7. 57. Kanwar SS, Canguly NK. Walia BNS. et al. Direct and antibody dependent 90. DavidsonRA. Issues in clinical parasitology:The treatmentof giardiasis.Am 1984;' cell mediated cytotoxiciry againstGiardia iambha by splenic and intestinal J Gastroenterol. 9:-116-61. lymphoidcells in mice. Gut. 1986;27:73-7. 91. Lerman SJ. Walker PA. Treatment of giardiasis:Literature review and U. Roberts-ThomsonIC,'Aitchell OF. Giirdiasis in mice:1. Prolongedinfections Clin Ptdiatr. 1982;21:409-14. rec-otrunectiations. in certain mouse strains and hypothyruc (nude) mice. Gastroenterology. 92. Wol-le VS. Sytnptomitology, diagnosis, and trc=iat. In: Eriandsen SL. 1978;75:42-6. Meyer EA, eds. Giardia and Giardiasis.New York: PlenumPress; S9. Duacombe VM, Bolin TD. Davis AE. et al. Histopathologyin giardiasis:A 1984:147-61. correlationwith diarrhea- Aust NZ J Med. 1978;8:392-6. 93. Craft JC. Murphy T, Nelson JD. Furazolidone andquinacrine. Comparative .W. Wright SO, Tomkins A.M. Quantihc2tion.of the iymphocyticinfiltrate in studyof therapy for giardia in children. Am J Dis Child. 1981-,135:164-6. epithelium in giardiasis.Clin Exp Immunol. 1977;'-19:409-12. je-junal 94. SpeelmartP. Single-doie tinid&zolefor the treatmentof giardiasis.Andmicrob 61. Heyworth MF, CarlsonrR, Ermak TH. Clearance of Ciardia murisinfection AgentsCherricither. 1985;-)7:227-9. requires helperiinducerT lymphocytes.J Exp Mad. 1987;165:17434. 95. Kruetner AK, Del Bent VE, Amstey MS. Giardiasisin pregnancy.Am J 62. TarganSR. The intestine as an immunologicorgan. In. TarganSR, moderator. ObstetGynecol. 1981.140.895-901. Immunologic mechanisms in intestinal diseases. Ann Interm Med. 96. Rotblan1,M. Giardiasisand amebiasisin prepancy. Drug Inteil Clin 1987;406:853-70. 1983.17:187-8. Phar-macol. 63. Owen RL, Allen CL, Stevens DP. Pbagocytosisof Giardia muris by 917. larroll EL. Bingham AX, Meyer EA. Giardia cystdestruction: Efrectiveness Imun. of six disinfectionmethods. I Med Hyg. in Peyer's patch epitheliumin mice. Infect 1981;33:591-1.mac-rophages small-quantity water Am Trop 601. 1980-,29:8-11. .64. Hill DR, Pearson RD. Ingestion of Giardia lamblia trophozoites by human 99. Kahn FH. Visscher BR. Water disinfectionin the wilderness:A simple, mononuclearphagocytes. Infect Ijr=un. 1987.55-3155-61. methodof iodination. West I Med. 1975.12-1:450-3. ef-fective 6S. Kaplan BS, Uni S, Aikaws M, et al. Effector mechanismof host resistance in murine giardiasis:Specific ISO &adISA cell-mediatedtoxicity. J Immunol. 1985.134-1975-81. 66. GM* FD, Reiner DS, Wang CS. Human milk kffls parasitic intestinal Science. 1983-.221:1290.-2. pro-tozoa. 67. Reiner DS, Wang CS, Galin FD. Human milk kMs Giardia lamblia by toxic lipolytic products. J Infect Dis. 1986;154-825-32. gen-emfing iA. Nayak N. GanguLyNK, Walia BNS, et al. Specific secretaryIgA in the trulk 258. TRICHOMONAS Of Giardia lamblid-infected and unidected women. J Infect Dis. 1997;155:724-7. .69- Islam A, Stoll BJ, LjungstrOm 1, et al. Giardia lambUainfections in a cohort VAGINALIS Of Bangladeshi mothers and infants followed for one year. I Pediatr. 1983;103:996-1000. MICHAEL F. REIN 70- Ament ME. Rubin CE. Relation of giardiasisto abnormalintestimid structure had ftnction in gastrointestinalimmunodeficiency syndromes. 1972-.62:216-26. Gastroenter-Ology. 1836.' 71. L*Gaft PR. Sampson HA. Buckley FLH. Symptomaticliardiasis in three Trichomonasvaginalis was first describedby Dorindin Patients with X-linked aptrint4ob"vemia. I Pediaer. 1982.101:73-40. Its accepmnceas a primarypathogen was gradual, and the older 7L commensal.' Ward H. Jalan KN. Maitra TK. et al. Small intestinal nodularlymphoid literaturefrequently refers to it as a harmless in patienu with giardiasisand normal serumimmunaglobulins. GUL by-Perplasia widespreadin natureand 1983:24:120-6. Closelyrelated organisms are are 73. SollamonsNW. G;,rdiasis: Nutritional implications. Rev Infect Dis. 1982. pathogensof cattle, amongwhich they arevenereally im-portant 4*&59-69. andfowl.' Otherorganisms in thesame also Questions? Contact FDA/CDRH/OCE/DID at [email protected], or 301-796-8118family Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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2 J. -Z- = 7, 8 - _; 'i 41 a -, 17 i =S Z 9 Z Questions? w ;ClU Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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Bacterial vaorinosisC) and trichomoniasisvaginitis arerisk factors for cuff cellulitis after abdominalhysterectomy
David L Soper, MD, Richard C. Bump, MD, and W. Glenn Hurt, MD RkAmand, Virgý
To assessthe relationshipbetween either bacterial vagino" or trichomoniasisvaginitis and posthystereaornyinfection, preoperative evaluation of thevaginal secretions was performed in 161 women undergoingabdominal hysterectomy. Thirty-two patents (19.9%) " 27 patients(16.8%). respectively. met Me diagnosticcriteria for bacterial vaginosis and trichomoniastsvaginitis. Patients with either bacterial vaginosisor trichomoniasisvaginitis were more likely than controlsubjects to have cuff cellulift, cuff abscess.or both(relative risk 3.Z 95%confidence interval 1.5 to 6.7 for bacterialvaginosis, relative risk 3.4. 95%confidence interval 1.6 to 7.1 fortrichomoniasis vaginitis). Preoperative vaginitis had no effect with respectto the incidenceof postoperative wound infection, urinary tract infection. or intravenousfine phlebitis.Bacteroides sp., Peptostreptococcus sp- and/or Gardnerellavagmahs (bacterial vaginosis 4b organisms')were isolatedfrom the vaginal cuff in Me majorityof patientswith postoperative cuff cellulitis. Bacterialvaginosis and trichomoniasisvaginitis are riskfactors for thedevelopment of posthysterectomy 3. cuff cellulifis.(Am J OssTErGywcoL 1990:163:1016-23.)
Key words: Bacterial vaginosis.trichomoniasis. cuff cellulids Copyright material
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FromAt Depanwwngof Obatmz!and CynmloV, Afe&cal CoUqe df V-0-1 V_r_ Cm-o'""" U-VMUY PrzenUdas Official Cuest at Abe Annual ion, of: Afeetingof L4wSouth Adanm An"wam Obsumciansand Cynecologuu. ra4ma ..I- Ploý I"-wo'yzs-.71. 1.9". Jteprmsrrquau: D",d Z.Soper. AID. lax 34, MCV Sm"n, VA 23298. MCA-xwn 616121838 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 1016 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
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Copyright material
JOURNAL OF CLINICAL MICROBIOLOGY. July 1983.p. 170-177 Vol. 18.No. i W95-1137,,'S3,'0701,-O-i)SS02.0010 CopyrightZ 1983.Amcriczn Society for Microbiology ith Diagnosis of Bacterial Vaginosisby Direct Gram Stain of VaLyinalFluid SPIEGEL.ý!t* CAROL A. RICHARD ALMSEL.AND KING K. HOLMES Departmentof Medicine,School of Medicine.UniversitY of Washington.Seattle. $17ashington 98195 Received31 January 1983,Accepted 11 April -1983
To determine whether bacterial vaginosis(BV). also known as nonspecific vaginitis. could be diagnosed by evaluating a Gram stain of vaginal fluid. we examined samplesfrom 60 women of whom 25 had clinical evidenceof BV and 35 had candidal vaginicis or normal examinations.An inverse relationshipbetween the quancityof the Lactobacillus morphOEVpeI large gram-positive rods) and of the Gardnerella morphotype (smallgram-variable rods) was notedon Gram stain (P < 0.001). When Gram stain showeda predominance(3 to 4-) of the Lactobacillits morphotype with or without the Gardnerella morphotype. it was interpreted as normal. When Gram stain showed mixed flora consistingof grann.-POSidVe. the* or gram-variable bacteria and Lacrobacillits morphotypegram-negative. was decreased or absent (0 to 2ý-). the Gram stainwas interpretedas consistentwith BV BV. Gram stain was consistentwith in 25 of 25 women stiven. a clinical dia-enosisof BV and in none of 35 women with candidal vaginicis or normal examinations. Duplicate slidesprepared from 20 additional specimensof vaginal duid were sEainedby two methodsand examinedby threeevaluators. InEereviua Eor interpretations and inEraevaluatorinterpretations of duplicate slideswere in agreement with one another and with the clinical diagnosisZ:90% of the time. We concluded that a microscopicallydetectable change in vaginal microflorafrom the Lacrobacillits morphotype. with or without the Gardnerella morphoEype to a mixed flora With few or no LacrobacillitsmorphoEypes ( B V) can be used (nor-mal). in the diagnosisof BV. Copyright material
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It SecondEdition if
Editedby BerttiriaB. Wentworth,Ph.D. Franklyn N.Judson, M.D. Maryj.R. Gilchrist, Ph.D.
AmimcAN PUBLic HEALTH AssOCIATION
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Chapter 6
VAGINITIS
Carol A Spiegel, Ph.D.
Triebomonas'vaginalis V2ginitis,7Yeast vaginitis,- Bacterial vaginosis, Isolation and identificationof Gardnerella vaginalis
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VAGINITIS
INTRODUCTION "vaginitis" The term literafl%means inflarrim ation of the vagina. It is by an increased v2ginal dischargecontaining manywhiEe blood char-acrerized cells. A diagnosisof vaginitis is made. in 45% of women visiting sexually transmitteddiseases (STD) clinics and hasbeen reported in 36% of college women student health clinics.Fifry percentof all casesof vaginitis "specific,"attending are i.e., due to Tricbomonasvaginalis or Candida "nonspecific," albicam, and the other 50% are i.e., not attributableto either of these two %w- agents. These proportions some,%%-hatwith the population vaginitis" being Most casesof "nonspecific have been attributed to a mixed exarri-ined. bacterial flora containing GardnerelLavaginahs (formerly known as raginalis or Con72ebacreriumvaginale). Bec2use%2ginal white Hae-mopbilus "vagifiosis" blood cells are not a prominent feature of thissmdrome, the term has been suggestedto indicate an increasedfluid flow without an increase v2ginosis" in inflamm21orvcells. The more descriOu'vename "bacterial has been used in recent literature and will be used in this ch2Dter. Bacterial%,aginosis and yeastvaginids differ from the classicalSTD in that: (1) etiologic agentsMay be members of the %-aginalendogenous flora, and (2) diseasedoes not alvý-aysrequire sexualcontact. For enomple,C albicans is found in the ý-aginasof as many as 50% of women who lack any signs or s,mpEornsof %raginitisMaginosis.BLIE, when sucha colonizedwoman is that is, when her estrogen level is increased,or when she is preg-nanE, overgrový.- taking antibiotics,C albicans may and cause%-aginitis. Thus diagnosisof yeastvaginitis cannotalways be made in the laboratory,but must be made by the clinicianwho can take into accountthe physicalfindings. On the other hand,symptoms (patient complaints)do not correlatevery well with a clinical diagnosisof v2ginjti&-'v2gMi0sis,making laboratorytests essentialto an diagnosis.These testsare described in detail here. ac-cur2Ee
TRICHOMONAS VAGINALIS VAGINITIS
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Number 135-Movember 1989 C " Technical Builetin 9 AnEducational Aid to Obstetrician--Gynecologists
Vulvovaginitis
Copyright material Vulvqvaginitisis one of the mostcommon complaints of womenseeking gynecologic care (1). Becauseof the s potentiallychronic orrecurrent nanire of thiscondition, it can be distressingto the patientas well as pose managementproblems to the physician.Recently, however,a new understandingof thepathogenesis of thesediseases has improvedthe managementof and outcomefor patientswith vulvovaginitis. ion
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SECTIONVI
Line Listing of PatientData AffirMTM Vp111 MicrobialIdentification Test for Candidaspecies, Gardnerella vaginalis, and hichomonasVaginalis
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PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV D IAG 3 4 Y N N Y Y (b)(6) Y THA Y N THA Y Y Y N N Y Y 0 Y N N N N N Y F Y N Y N N N Y THA N Y N N Y Y Y Y Y N N Y Y Y THA N N N Y N N Y THA N Y N N Y Y Y C N N N Y N N Y THA Y N N Y N Y THA Y Y N N Y Y Y THA Y Y N N Y Y N 0 Y N N N Y N Y C N N N Y N N Y THA Y N N N N N Y THA Y Y N N N Y N THA Y N Y N N N Y THA Y N N N N N Y THA Y Y N N Y Y Y THA Y N N Y N N Y 0 Y N Y N N N Y 0 N N N N N N Y THA N N N N N N Y N N N N N N N Y THA N N N Y N N Y THA Y Y N N Y Y Y THA Y Y N N Y Y Y N Y N N N N N Y F Y Y Y N Y Y Y C N N N N N N Y N N N N Y N N Y THA Y Y N N Y Y Y 0 Y Y Y N N N Y THA N N N N N N Y THA Y Y Y N Y Y Y THA Y Y N Y Y Y Y C N N N Y N N Y THA Y Y N N Y Y Y THA Y N N Y y Y Y THA N Y N N Y Y Y THA Y Y N N N Y N N Y N N N N N Y F Y Y Y N Y Y Y THA- Y Y N Y Y Y Y Y N Y N Y N N F Y N N N N N Y THA Y Y N N Y -F Y c N N N N N N Y THA Y Y N N N Y Y C N N N Y N N Y 0 N N N N N N Y THA N N N Y N N Y THA Y Y Y N N Y Y N N N Iq N N N Y 0 Y Y N N N N Y N N N N N N
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Candida species 510(k) Submission
PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN N 0 y 35000 N (b)(6) VP2CP1112 N N y 0 N 0 N N N 0 N 0 N N y 0 N 0 N N N 0 y 35000 N N N 0 N 0 N y N 0 N 0 N N 0 N 0 N y N 0 y 350 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 1 y 3500000 y N 1 y 3500000 N N. 0 N 0 N N 0 N 0 N N y 0 N 0 N N N 0 N 0 N N N 0 N 0 y N 1 y 3500000 y N y 0 N 0 N N N 0 N 0 N N N 0 N 0 N N 0 N 0 N y N 0 N 0 N N 0 N 0 N N 0 N 0 N N N 0 N 0 N N y 0 N 0 N N N 0 N 0 N y N 0 N 0 N N 0 N 0 N N y 0 N 0 N N N 0 N 0 N N y 0 N 0 N y N 0 N 0 y N I y 350000 y N N 0 N 0 N y N I y 350000 y N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N y 0 N 0 N y N 0 N 0 N y 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N I y 350000 N N 0 N 0 N y N 1 y 3500000 y N y 0 N 0 N N 0 N 0 N, N 0 ' 0 N. N 0 N 0
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PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 VP2CP1281 Y THA y y N N y Y (b)(6) Y 0 N N N N N N N 0 N N N N N N N THA Y Y Y N Y y Y THA Y y N y N Y Y THA N Y Y N N N Y THA Y N N N N N Y 0 y N N y N N Y THA y Y N N Y Y y THA Y Y N N Y y Y o N Y N N y Y C Y J N N y Y y N
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2CP1281 N N 0 N 0 (b)(6) N N 0 N 0 N N 0 N 0 N y 0 N 0 y N 1 y 3500000 y N y 0 N 0 N N N 0 N 0 N y N 0 N 0 N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N ___Y N 1 Y 1 3500000 1 y
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DISCHARGE- PATIENT ID SYMPTOM PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV D IAG 3/4 VP2DBI321 Y N N N N (b)(6) N N N Y THA Y N N N N N Y THA Y Y N N Y Y Y N N N N N N N Y 0 Y N Y N N N Y N y N N N N N Y THA Y Y N N Y Y Y C y N N Y N N y 0 Y N N N N N Y N N N N N N N Y 0 Y N N N N N Y N Y Y N N Y y Y C N N Y N N Y 0 N Y N N N N Y N N N - N N N N Y THA Y Y N N Y y Y THA Y N N N N N Y 0 Y N N N N N Y THA Y Y N N N y Y C Y y N Y Y y Y THA Y Y N -N N y Y N Y N N N N N Y 0 N N N N N N Y THA Y N Y N N N Y 0 Y N N N N N Y 0 N N N N N N Y THA Y N N N Y y Y C Y y N Y N N
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN (b)(6) N N 1 y 370000 N N 0 N 0 N N 0 N 0 N N 0 y 3700 N y 0 y 3700 N N 0 y 370 N N 0 N 0 y N 1 y 3.7E+08 N N 0 N 0 N N I y 370 N N 0 N 0 N N 0 N 0 y N 1 y 3.7E+08 N N 0 y 37000 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0- N 0 N N 0 N 0 N N 0 N 0 N N 1 y 370 N y 0 N 0 N N 0 N 0 N N 0 -N 0 N N 0 N 0 y N 1. y 370000
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PATIENT ID SYMPTOM DISCHARGE PH>4. 5 CLUE CELLS TRICH PSEUDOHY AMINS OD BV DIAG 3/4 VP2DMO221 Y THA N N N Y N N (b)(6) N N Y N N N N N y THA Y N N Y N N Y THA Y N N N N N Y F N Y N N N N THA Y N N Y N N Y C Y N N N N N Y C N N N N N N N- N F Y N Y N N Y THA Y Y N Y Y Y Y THA Y N N N N N N N Y Y N N Y Y N THA Y N N N N N N 0 N N N N N N Y C Y N N N N N Y C Y Y N N Y y Y 0 N N N N N N Y C N N N N N N Y N Y N N Y N N Y N N N N N N N Y Y N N Y Y Y C N N N N N N Y 0 N N N N N N Y C N N N N N N Y C y N N N N N Y 0 Y N N N N N Y THA Y Y N N Y y Y THA Y N N N N N Y C Y N N Y N N Y THA N N N N N N N C N N N N N N N THA Y N N N N N N C N N N Y N N Y F Y Y Y N N Y N Y N N N N N Y THA N N N N N N Y THA Y Y N N Y Y Y THA N N N N N N Y 0 Y N N N N N Y 0 Y N y Y N N Y F Y N N N N N Y THA Y N Y N N Y 0 Y N Y N N N 0 N N N N N Y 0 Y Y N N Y y Y 0 N N- N N N N Y THA Y Y N N Y y Y THA N Y N N Y Y Y THA N Y N N N N Y THA N Y N N Y Y Y THA N N N N N N N THA N N N N N N THA N N N N N N Y THA Y N N N N N Y 0 -Y N N Y N N Y THA Y Y N Y Y Y
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2DMO221 y N 1 y 7100 y (b)(6) N N 0 y 7100 N y N 1 y 710 N N N 0 y 71000 N N y 0 N 0 N y N 1 y 71000 y N N 0 N 0 N N N 0 N 0 N 0- y N N 0 y N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 1 y 71000 N N N I y 710000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 1 y 7100 N y N 1 y 710000 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y N 1 y 710-0000 y y 0 N 0 -VP2DMO269 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N 0 y 710 N y y 0 N 0 N N 0 N 0 N y N 0 y 710 y N 1 y 71000 N N N 0 y 71000 N N N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N N 0 y 7100 N N N 0 N 0 N N 0 y 7100 N N N 0 N 0 y N 0 N 0 y N 0 N 0
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PATIENT ID SYMPTOM DISCHARGE PH>4. 5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4
(b)(6) Y C Y Y N Y N N Y 0 Y N N N N N N C N N N N N N N N Y N Y N N N Y 0 Y N N N N N Y F Y N N N N N Y Y Y N N Y Y Y C Y N N Y N N Y 0 N N N N N N N N N N N N N N Y THA N N N N N N y 0 N N N N N N Y C N N Y N N y THA N N N N N N N THA Y Y N N Y y N 0 Y N N N N N Y THA Y N N Y N N Y C N N N N N N Y 0 Y N N N N N Y 0 Y N N Y N N Y 0 Y N N N N N N C N N N N N N Y C Y Y N N Y y Y C N N N Y N N Y 0 Y N N Y N N Y 0 N N N N N N Y C Y N N Y N N N N N N N Y N N N N N N N N N N N THA N N N N N N N THA N N N N N N Y THA Y N N N N N Y C N N N Y N N Y THA N N N N N N Y C Y N N N N N Y C Y N N N N N Y C Y N N Y N Y F Y N Y N N N Y N Y N N N N N N N N N N N N N Y C Y N N Y N N Y THA N N N N N N N 0 Y N N N N N N 0 Y N N N N N Y C Y N Y Y N N N N N N N Y N N N 0 N N N N N N Y C N N N Y N N Y Y N N Y N N Y C N N N N N N Y C N N N N N N N THA Y N N N N N N THA Y Y N Y Y y Y THA Y N N Y N N -N THA Y N N N N N Y N I N N N N I N
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2DM0392 y N 1 y 71000 (b)(6) N N 0 y 7100 N N N 0 N 0 N N y 0 N 0 N N N 0 y 7100 N N N 0 N 0 N N N 0 N 0 N y N 1 y 7100000 y N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 0 N 0 N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N I y 71000 N N N 0 -N 0 N N N 1 y 71000 y N I y 71000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N I y 710000 y y N I y 7100000 y N N 0 N 0 N y N 0 y 7100 N y N 0 y 710 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N I y 71000 N N N 0 N 0 N N 0 N 0 N N N 0 N 0 y N 0 N 0 N y 0 N 0 N N 0 N 0 N 0 N 0 N y N 0 -N 0 N N 0 N 0 N N N 0 y 7100 N N 0 N 0 N y y 0 N 0 y N 1 y 7100 N N N I y 71000 N Y. N 1 y 710000 y y N I y 71000 N N N 0 N 0 N N N 1 y 71000 N N N 0 N 0 N y N 0 N 0 y N 0 N 0 N N 0 N 0 N N N I N a I w
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
li Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 Candida species 510(k) Submission
3/4. -PATIENT ID SYMPTOM DISCHARGE PH>4. 5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV DIAG _VP2DM0485 Y THA Y Y (b)(6) N N Y Y Y C N N N Y N N Y THA Y N N N N N N THA N N N N N N Y 0 Y N N N Y N Y Y N N N N N Y N Y Y N N Y Y Y THA Y y N N Y y Y THA Y Y N Y Y Y Y THA Y N N N N N Y THA Y y N N Y y Y C N N N Y N N N N Y Y N N Y Y Y C Y N N Y N N N C Y N N N N N Y 0 Y N N N N N Y THA Y N N N N N Y THA Y Y N N Y Y Y C Y N N N N N y THA Y N N N N N Y THA N Y_ N N Y Y Y THA Y N N N N N M Y N N N N N N N
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2DMO485 N N 0 N 0 N (b)(46) y N 1 y 7100000 N N N 0 N 0 N N N. 0 N 0 N N N 0 y 710 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 1 y 710!00 N N N 0 N 0 N N N 0 N 0 N y N 1 y 710050 y N N 0 N 0 N y N 0 y 710 N N N 0 N 0 N N N 0 N 0 N N 0 N 0 N N 0 N 0 N N N 0 N 0 N N N 0 y 7100 N N 0 N 0 N N 0 N 0 N N 0 y 71000
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PATIENT ID SYNPTOM DISCHARGE PH>4. 5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 VP2JM0551 y C y N y y N N (b)(6) y C N N N y N N y C N N N N N N y C N N N N N K y THA y y N N y y y C N N N N N N y 0 N N N N N N y C N N N y N N y THA y y N N N y Y, y THA y N N y y y C N N N N N N y P y N N N N N y THA y y y N y y y C N N N y N N y C N N N N N N y THA y y N N y y y THA y y N N y y y C N N N y N N y THA y y N N y y y THA N y N N N N y THA y y N N N y y THA y y N N N y y 0 y y N N N N y THA N N N N N N y C N N N N N N y THA N N N N N N y N N N N N N N y C N N N N N N y THA y y N y y y y N N N N N N N y THA y y N N N y y THA y y N N y y y THA y N N N N y THA y y N N y y y THA y y N N y y y 0 N N N N N N y C N N N y N N y THA N N N N y N y F y N y N N N y THA y y N N y y y C N N N N N N y C N N - N N N N Y THA y y N N y y y 0 y N N N N N y THA N N N N N N y TRA y N N N N N y N N N N N N N y C N N N y N N y C N N N N N N y N N N N N N N N N N y N N N N y 0 y N N N y N N N N N N N N N y C N y N N N N y 0 N N N N N N N N N N N N N N
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN -VP2JM0551 y y 1 y 45000 (b)(6) y N 1 y 4500000 y N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 1 y 4.5E+07 y N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 1 y 450000 y N y 0 y 450000 y N 1 8000 N N N 0 N 0 N N 0 N 0 N N N 0 N 0 N y N 1 y 450000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 y N N 0 4500 N y N 0 y 450 N N N 0 y 4500 N N 0 N 0 N N N 0 N 0 N N N o y 45000 N N N 0 N 0 N N N 0 N 0 N N N 0 y Y_ 4500 N y N I 450000 y N N 0 N 0 N N y 0 N 0 N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N 0 N 0 y N 1 y 4.5E+07 y N_ N 0 N_ N 0 N 0 0 N N o N 0 N_ N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N 0 N 0 140000
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PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DUZ 3/4 VP2JM0624 N N Y Y N N N N (b)(6) y C N N N N N N N 0 N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N y N N N N N N N y F Y Y N N Y Y Y 0 N N N N N N N, N N N N N N N Y C Y Y N N Y y N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N Y THA Y Y N N N Y Y 0 N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N 0 N N N N N N Y C N N N N N N N N N N N N N N Y THA Y Y N N Y y Y C N N N N N N Y THA y Y N N Y Y Y THA Y Y N N Y Y Y C N N N Y N Y C N N N Y N N N N Y N N N N Y N N N N N N N Y N Y Y N N N N N N y N N Y N N Y N Y N N N N N Y C N N N Y N N Y N N N N N N N Y THA y Y N N Y Y Y THA Y Y N N Y y Y TRA Y Y N N Y Y Y THA Y Y N N N Y N 0 Y Y N N N N N 0 N N N N N N Y THA Y Y N N Y Y Y N N N N N N N Y 0 N N N N N N Y THA Y Y N N Y Y Y 0 N N N N N N Y THA y Y N N y Y N N N N N N N N y THA Y Y N N Y y Y N N N N N N N Y 0 N N N N N N Y 0 N N N Y N N Y 0 N N N N N THA Y Y N N Y Y
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2JM0624 N N 0 N 0 (b)(6) N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N N 0 y 4500 N N 0 N 0 N N 0 N 0 N N 0 y 45000 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0. N 0 N N N 0 N 0 N -N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0- N 0 N N 0 N 0 N N 0 N 0 N N N 0 N 0 N y N 0 y 45000 N y N I y 45000 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 1 y 45000 N N 0 N 0 y N I y 450000 N N N 0 N 0 . N N N 0 y 4500 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 y 45000 N N N 0 N 0 N N N 0 y 4500 N N N 0 N 0 N N N 1 N- y 45000 N N N 0 0 N N N I y 45000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N .0 N 0 N y N 0 y 45000 N N N 0 N 0 N N N 0 N 0
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PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 VP2JM0694 Y 0 y Y N N Y y (b)(6) Y C N Y N Y N N Y THA y Y N N N Y N N N N N N N N Y 0 N N N N N N Y 0 Y Y N N N N Y N N N N N N N Y 0 N N y N N Y C N N Y N N Y C N N N N N Y 0 N N N N N Y N N N N N N N Y C N N N Y N N Y THA N Y N N N N Y THA y y N N Y y Y 0 N Y N N N N Y 0 y Y N N Y Y N 0 N N N N N N Y 0 y Y N N Y y N N N N N N N N Y N N N N N N N Y C y Y N N N N Y N N N N N N N Y N N N N N N N Y 0 N N N N N N N' Y 0 N N N N N Y 0 y N N N N N Y 0 Y Y N N N N Y N N N N N N N Y 0 y N N N N N Y THA y y N N Y y Y F y N Y N N N Y 0 Y y N N N N Y 0 N Y N N N N Y THA y y N N Y Y Y 0 N y N y N N Y 0 N N N Y N N Y 0 N N N N N N y 0 y N N Y N N Y C N N N y N N Y 0 y N N N N N Y 0 N N N Y N N Y 0 N N N y N N N N N N N N N N N N N Y N N Y N N N Y Y N N Y y N N N N N N N N N N y Y N N y y Y N Y Y N N Y y Y N N N N N N N N N N N N N N N N N N N N N N N N N N Y. N N N N N N N N N N N N N N N N N N N N THA y Y N y
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2JM0694 N N 0 N 0 N (b)(6) y N I y 4500000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 y 45000 N N N 0 N 0 y N 1 y 4.5E+07 y y N I y 45000 N N N 0 N 0 N N N 0 N 0 N N 0 N 0 y N 1 y 20000 N N N 0 y 80000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0. N 0 N N 0 N 0 N N N 1 y 45000 N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 1 y 800000 y N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 0 N 0 N N 0 y 45000 N N 0 -N 0 N N 0 N 0 y N 0 0 y N I y 4.5E+07 N N 0 N 0 y N 0 N 0 y N I y 4.SE+07 N N 0 N 0 N y N 0 y 8000 y N I y 80000 N N 0 N 0 N N 0 N 0 N N 0 -N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N I y 4500 N N 0 y 4500 N N y 4. E+07 N N 0 N 0
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PATIENT ID SYMPTOM DISCHARGE PH>4.5. CLUB CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 VP2JM1563 y THA y Y N N N Y (b)(6) N C N y N N N N N N Y N N N N N N N N N N N N N N N N N N N N y N N N N N N N N N N N N N N N N 0 N N N N -N N N N N N, N N N N N N N N N N N N N N N N N N N Y 0 Y y N y Y Y N N N N N N N N N N N N N N N N N N N N N N N N y C N N N y N N N N N N N N N N N N y N N N N N Y N N N N N N N Y N N N N N N N N N Y Y N N N N Y TRA Y Y N N Y Y N N Y N N N N N N N N N N N N N Y 0 Y Y N N Y Y N THA N N N N N N N N N N N N N N N N Y N N N N N N N N Y N N Y N Y N Y Y N N y Y N F Y Y N N N N N N N N N N N N N N N N N N N N N 0 Y Y N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N Y THA Y y N N N Y N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N Y C N N N Y N N Y N N N N N N N N N N N N N N N N N Y N N N N N y THA Y Y N N Y Y N 0 N N N N N N N N N N N N N N Y N N N N N N N Y TRA Y Y, N N Y Y Y C N N N N N N N C N N N N N N N N N N -N I N N
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2JM1563 N N 0 N 0 (b)(6) N N 1 y 45000 N N 0 N 0 N N 1 450000 N N 0 N 0 N N y 9E+07 N N 0 N 0 N N 1 y 45000 N N 0 y 450 N N 0 N 0 N N 0 N 0 y N 1 -y 4.59+07 N N 0 N 0 N N 0 N 0 N N 0 y 450 y N 1 y 4.5E+07 N N y 45000 N N 0 N 0 N -N 0 y 450 N N 1 y 45000 N N 0 N 0 N N 0 N 0 N- N 0 N 0 N N 0 y 45000 N -N 0 y 4500 N N 0 N 0 N N N 0 N- N 0 N 0 N N I y 45000 N N 0 y 450 N N 0 N 0 N N N 0 N N 0 - N 0 N N 6 N 0 N N 0 N 0 N N 0 Y - 450 N N 1 y 80000 N N 0 N 0 N N 0- N 0 N N 0 N 0 N N T y 4.5E+O7 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N I y 450000 N N 0 N 0 N N 1 Y - 80000 N N 0 N 0 N N 0 y 45000 N N 1 y 45000 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 . 0 N N 0 N 0 J N N 67 N 0 -VP2JM1628
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PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 VP2JM1629 y THA y y N N y y (b)(6) N N y N N N N N N N N N N N N N N N N N N N N N N N N N N y N N N N N N N N N N N N N N N N N N y F y y N N y y N N N N N N N N N N N y N N N N y THA y y N N y y y 0 N N N N N N N C N N N N N N y TRA y y N N y y N N N N N N N N N N y N N N y N y 0 N N N N N N N N N N N N N N N N N N N N N N N N N N- N N N N Y THA y y N N y y N N N N N N N N N C N N N N N N N N N N N N N N y C N y N N N N N N N N N N N N y THA N y N N N N y F y y y N y y y THA y y N N y y y THA y y N N y y N N N N N N N N N N y N N N N N N N N N N N N N N N N N N N N N N THA y y N y y N N y y N T y y
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2JM1629 N N 0 N 0 (b)(6) N N 0 N 0 N N 1 y 450000 N N 0 N 0 y N 1 y 45000 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 y 4500 N N 0 N 0 N N 0 N 0 N- N 0 N 0 N iq 0 y 4500 N N 0 N 0 N N I y 4.5E+07 N N 0 N 0 N N 0 y 450 N N 0 y 45000 N N 0 N 0 N N 0 y 450 N N 0 N 0 N N 1 y 45000 N N 0 y 45000 N N 0 y 45000 N N 0 y 80000 N y I y 4.5E+07 N N 0 - N 0 N N 0 N 0 N N 0 N 0 N N 0 y 4500 N N 0 Y- N 0 N N 0 450 N N -0 N 0 N j 0 N 0
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PATIENT ID SYMPTOM DISCHAPGE PHA. 5 CLUE CELLS TRICH PS9WOHY AMINE OD BV DIAG 3/4 VP2SH0771 y 0 Y Y Y N Y Y (b)(46) y C N N Y N Y N y C Y Y Y N y Y N N N N N N N N N N N N N N N y C Y N N Y N N N N Y Y N N N N N THA Y N N N N N y TRA N N N N N N N N Y N N N Y N Y THA Y Y N N Y Y y N N N N N N N y THA N Y N N N N Y N Y Y N N Y Y Y C N N N y N N Y THA Y Y Y N Y Y Y THA N N N N N N N THA N N N N N N y THA Y Y Y N N Y Y N N N N N N N y TRA Y Y Y N Y y Y 0 Y N N N N N Y THA N N N N N N y THA Y Y N N Y Y N N N N N N N N N TRA Y y N N Y Y y TRA Y Y N N Y Y N THA N N N N N N N N N N N N N N N C N N N Y N N N F Y N Y N N N Y TRA Y Y N N Y Y N THA Y Y N N Y Y Y C N N N Y N N Y THA Y Y N N Y y y TRA Y Y N N Y Y N THA N N N N N N N THA N N N N N N N THA y Y N N Y Y Y THA Y N N N Y -Y N N Y N N N N N y THA Y Y N N Y Y N N N N N N N N N N y N N N Y N N C N N N N N N N N N N N N N N N C N N N N N N N N N N N N N N y THA Y Y Y N Y Y Y 0 Y N N N Y N Y THA y N N N N N Y THA Y Y N N y Y Y TRA Y N N Y N N - Y TRA Y Y N N Y Y N N N N N N N N N N I N N N N N N
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PATIEW ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2SH0771 N y 0- N 0 N (b)(6) N y 0 N 0 N N y 0 N 0 N N N 1 y 1000 N N N 0 y 60 y N I y 1000000 y N N I y 300 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N Y- N I y 10000 N N y 0 N 0 N N N 0 N 0 N N N 0 N 0 N N y 0 N 0 N N N 0 N 0 N N y 1 y 10000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 0 y so N y 0 N N N N 0 N 0 N N N 0 N 0 N y N I y 1000 y N N 0 N 0 N N N 0 N 0 N N N 1 y 10000 y N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N- N T N 0 N N N 0 y 20 N N N 0 N 0 N N A 0 N 0 N N- N 0 N N N N 0 N 0 N N N 0 N 0 N N N 0 y so N N y 0 y so N N N 0 N 0 N N N 0 y 20 N N N 0 y 10 N y N 0 N 0 N N 0 N 0 N N N 0 y 1000 1 N T N 0 N 0 N I
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PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEMORY AMINE OD BV DIAG 3/4 VP2SH0847 Y 0 N N N N N (b)(6) N F N N N N Y N Y 0 Y y Y N Y Y N C N N N N N N Y THA Y y Y N Y Y Y C Y N N Y N N Y THA N Y N Y Y Y Y C N N N Y N N N N N N N N N N N N N N N N N N N THA y N N N N N Y THA Y Y N N Y y N N N N N N N N Y C N Y N N N N Y THA Y N N N N N N N N N N N N N Y THA Y Y N N Y y Y C N N N N N N y C N N N N N N N THA Y Y N N Y y N N N N N N N N y THA Y Y N N Y Y y C Y Y N N Y Y y C N N N N N N Y C N Y N Y N N N C Y Y N N Y Y Y C N N N N N N N N N Y N N Y N N THA N N N N N N Y THA Y Y N N Y Y Y C N N N Y N N Y N N N N Y N N N N N N N N N N N THA Y y N N Y Y N N N N N N N N N N N N N N N N y C N N N N N N Y C N N N N N N N N N N N N Y C N N N N N N N N N N N N N N Y THA Y Y N N Y y N C N N N N N N Y C Y N N Y N N y THA Y Y N N Y y y C Y Y N N Y Y Y C N N N Y N N N C N N N N N N Y C N Y N N Y Y N 0 Y N N N N N Y C N N N Y N N y C Y Y N N Y y N C Y Y N N Y y y THA Y Y N N Y Y Y C Y Y N Y Y Y N N 1 -1 N N N N
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PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN
(b)(6) N N 0 N 0 N N N 0 y 1000 N N y 0 N 0 N N N 0 N 0 N N y 0 N 0 N y N 0 y 500000 N y N 0 y 10000 y y N 1 y 10000 N N N 0 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 y 10 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N iF N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N I y 3000 N N N 0 N 0 N N N 0 y 100 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 1 y 1000 N y N 0 y 3000 y N N 0 N 0 N N N 0 N 0 N N N- 0 N 0 N N N 0 N 0 N N N I y 30 N N N 0 y 20 N N N 0 y 1000 N N N 0 y 10 N N N 0 y 10 N N N 0 N 0 N N N 0 N 0 N y N 1 y 100000 N N N 0 y 5000 N N N 0 N 0 N y N I y 80 N N N 0 N 0 N N N 0 N 0 N N N 0 y 1000 N y N 1 y 1000 N N N 0 N 0 N N N 0 N N N -N 0 N 0 N y N i y 100000 - N N 0 N 1 0 N i-T
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PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICli PSEUDOHY AMINE OD BV DIAG 3/4
(b)(6) Y TRA N N N N N N y THA Y y N N Y Y Y THA N Y N N N N Y THA Y y N N N y Y C N N N N N N N THA N N N N N N N THA N Y N N N N Y TRA Y N N N N N Y 0 Y Y N N Y Y Y N Y N N N N N N N N N N N N N Y 0 y N N N N N N N N N N N N N Y C N N N Y N N N 0 N N N N N N Y THA y N N N N N N TRA Y Y N N N Y N THA N N N N N N N N N N N Y N N Y N Y y N N Y y N N N N N N N N Y THA N N N N N N N THA Y Y N N y Y Y THA Y Y N N Y Y N c N N N N N N y THA Y y Y N Y Y Y C N N N Y N N N N N N N N N N Y N N N N N N N y C Y N N N N N N N y Y N N N N Y N N N N N N N N N Y Y N N N N N N Y y N N Y y 0 Y Y N N Y y N 0 Y N N N N N Y C Y Y Y Y Y y N THA N N N N N N N THA Y y Y N Y Y N N N N N N N N Y THA y Y N N Y Y N TRA Y Y N N y Y y 0 Y Y N N Y y Y THA Y Y N N N Y Y C N N N N N N N N N N N N N N Y THA Y Y Y N y y Y THA N N N N N N N N N N N N N N N THA N N N N N N C N N N N N N Y N N N N N N N Y THA Y Y N N y y N 0 N N N N N N Y N N N N N N N Y C N N N N _N N
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qA Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 Candida species 510 (k) Submission
PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA cFu GRAM STAIN VP2SH0919 N N 0 N 0 N (b)(6) 0' N N 0 N N N N 0 N 0' 0 N N N 0 N N N N 0 N 0 N N N 0 " N 0 0" N N N 6 N N N N 0 N 0 N N- 0' N 0 N N N N 0 N 0 N N N 0 N 0 N N N 0 N 0' 0 N N N 0 N N y N I y 1000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 0 y 10 N N N 0 N 0 N N N 0 y 50 N N N 0 N 0 N N N 0 y 1000 N N N 0 N 0 N N N 0 N 0 N N y 0 -N 0 N y N 0 N 0 N N N 0 N 0 N N N 0 N - 0 N N N 0 ii 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y y I y 1E+07 y N N 0 N 0 N N y 0 N 0 N N N 0 N 0 N N N 0 y 50 N N N 0 N 0 N N N 0 N 0 N N N 0 y 20 N N N 1 y 10 N N N 0 y 10 N N y 0 N 0 N N N 0 y 10 N N N 0 N 0 N N N 0 N 0 N N N 1 y 500000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 y N N 0 N o I N 1 N 1 0 N
LINELIST.WKI Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 Candida species 510 (k) Submission
PATIENT ID SYMPMM DISCHARGE PH>4. 5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4
(b)(6) N C N N N N N N y THA N N N N N N y THA y y N N y y y THA y y N N y y y N y N N N y N N N N N N N N N N THA y y N N y y N 0 y N y N N N N 0 N N N N N N y THA y y N N y y y 0 y y N N y y y F y y N y N N THA y N N N N N N N N N N N N N y N N N N y N N y C y N N N N N N N N N N N N N N 0 y y N N N N N N y y N N N N y 0 N N N N N N N 0 y N N N N N N THA N N N N N N N THA N N N N N N N N y y N N N N y C N N N N N N y THA N N N N N N y THA y N y N N N y C y y N N y y y N N N N N N N y THA N N N N N N y C y N N N N N N 0 y N N N N N y THA y y N N y y y THA y Y N N y y N F y N N N N N N N N N N N N N N N N N N N N N y C N N N N N N N N y N N N N N y C y y N N N y N THA y y y N y y N THA y y y N y y N N N N N N N N N 0 y y N N y y N N N N N N N N y C y y N y N N N THA y y N N y y N N N N N N N N N THA N N N N N N N 0 y y y N y y N 0 y y N N N N N N N N N N N N y C N N N y N N y THA y y N N. y y N C N N N N N N N N N N iq N
LIKELIST.WK1 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 Candida species 510(k) Submission
PATIENT ID CAND DIAG TRICH DTAG PAC CA CA CULTURE CA CFU GRAM '§TAIN
(b)(6) N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 y 20 N N 0 y 10 N N N 0 y 10 N N y I y 1000000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N y ' 0 N 0 N N N a N 0 N N N 0 N 0 N y N 1 y 100 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N I Y 50 -N N N 0 N 0 N N N 0 N 0 N y N 0 N 0 N N y 0 N 0 N N N 0 N 0 N N N 0 y 10 N N N 0 N 0 N N N 0 N 0 N N N 0 y 1000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 y N N 0 y 50 N N y 0 N 0 N N y 0 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N 1 y 100000 y N N 0 N 0 N N N 0 N 0 N N 0 y 100 N N y 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N I y 1000 N M N 0 y 50 N N N 0 N 0 N N N 0 N 0 N
LIKELIST.WK1 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 Candida species 510(k) Submission
PATIENT ID SYMPTOM DISCOARGE PH>4.5 CLUE CELLS TRICH PsruDoHY AMINE OD BV DIAG 3/4
(b)(6) y THA Y N N N Y y N 0 N N N N N N -VP2SH1971 Y THA Y Y Iq N Y Y Y THA Y Y N N Y Y Y F Y Y N N Y Y Y THA Y N N N N N Y THA Y Y N N Y Y Y 0 N N N Y N N Y F N N Y Y N N N THA N N N Y N N Y C N N N Y N N Y N N N N Y N N N 0 N N Y N N N C N N N N N N N N N N N N N N N THA Y N N N N N N Y Y Y N N 0 Y N N N N Y N N N N N N N Y THA Y Y N N -N y N N N N N N N N N F Y N N N N N N N N N N N N C N Y N N 0 N N N N N
LINELIST.WK1 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 Candida species 510(k) Submission
-PATIENT ID CAND DIAG TRICH DIAG PAC CA CA CULTURE CA CFU GRAM STAIN VP2SH1970 N N 0 N 0 (b)(6) N N N 0 N 0 N N N 0 y 5000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N y N I y 1000 N y y 0 y 1000 N y N 0 N 0 N y N 1 y 5000 N y N I y 1000 N y N 0 N 0 N N N 0 y 100 N N N 0 N 0 N N N 0 N 0 N N y 0 y 1000 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 1 y 10 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N N N 0 N 0 N
LINELIST.WK1 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Cardnerella vaginalis
PATIENT ID SYMPTOM DISCHARGE PH > 4.5 CLUE CELL TRICH PSEUDOHY AMINE OD -GramInt (b)(6) Y THA Y Y Y N Y BV Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y C Y Y Y N Y BV Y Y Y N Y Y BV Y N N N N N N NL Y N Y N N N N NL Y THA Y Y N N N BV Y N Y N N N N BV Y N N N N Y N IN Y C N N N N N NL Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y C Y N N Y N NL Y THA Y Y Y N Y BV Y THA Y Y N N Y BV Y THA N N Y N N IN Y THA N Y N N Y BV Y THA Y Y Y N Y BV Y N N N N N N NL Y N N Y N N N BV Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y C N N Y N N NL Y THA Y Y N N Y BV Y 0 Y Y N N Y BV Y 0 Y N N N N NL Y C N N N Y N BV Y C N Y N Y N lqL Y THA Y N N N Y BV Y 0 Y Y N N Y BV Y 0 Y Y N N Y BV Y F Y Y N N Y BV Y THA Y Y N N N NL Y 0 Y Y N Y N NL Y C Y Y N Y N NL Y F Y N N N N BV Y 0 Y N N N N NL Y C N N N N N IN Y THA N N N N N NL Y THA Y Y N N N BV Y 0 N N N N N IN Y 0 Y Y N Y Y BV Y THA Y Y N N Y BV Y 0 Y N N N Y BV N' Y C N N Y N NL Y THA Y Y N N N BV N N N N N N N BV 7' Y 0 Y N N Y BV Y THA N N N Y N NL Y C Y N N N N NL Y THA Y Y N N N BV Y C N Y N Y N N 0 N N N Y N Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WKI [email protected] or 301-796-8118#3 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID GramSc GRAM GV BV DIAG 3/4 CAND DIAG TRICH DIAG GV CULT (b)(6) 7 4 y N y 3 7 4 y N N 0 10 4 y N N 2 8 4 y N y 2 8 4 y Y- N 2 0 0 N N N 0 0 0 N N N 0 a 4 y N N 2 8 4 N N N 3 4 4 N y N 0 0 0 N N N 0 8 4 y N N 0 10 4 y N N 1 8 4 y N N 1 3 3 N y N 0 9 4 y N y 0 8 4 y N N 3 5 4 N N y 0 8 4 y N N 0 8 4 y N y 0 0 0 N N N I 8 4 N N N 0 10 4 y N N 3 8 4 y N N 2 0 0 N N y 0 8 4 y N N 2 8 4 y N N 2 0 0 N N N I 7 4 N y N 2 0 0 N y N I a 4 y N N 2 8 4 y N N 2 8 4 y N N 2 8 4 y N N 2 0 0 y N N 1 0 0 N y N 1 0 0 N y N 0 10 4 N N N 0 2 0 N N N 2 4 4 N N N 2 0 0 N N N 1 8 4 y N N 2 4 3 N N N 1 8 4 y y N 2 8 4 y N N 1 a 4 N N N 2 0 0 N y N 0 9 4 y N N 2 8 4 N N N 2 10 4 y N N 2 3 3 N y N 0 0 0 N y N 0 9 4 y N N 2 6 4 N y N 2 6 4 N y N 0
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardr2erella vaginalis
PATIENT ID GV CULT QUAN PAC GV (b)(6) I 2 1 3 1 0 0 3 2 3 0 2 I 2 0 3 3 0 3 2 0 3 1 10000 1 0 0 10000 3 10000 2 18 0 10000 3 100 0 10000 3 10000 3 10000 3 10000 1 66 0 51 0 0 0 0 0 10000 1 10000 3 52 0 10000 3 40 1 10000 2 1000 3 10000 1 0 0 10000 3 10000 3 10000 1 0 1 0 0 10000 3 10000 1 0 0
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission C7ardnerella vaginalis
PATIENT ID SYMPTOM DISCHARGE PH > 4.5 CLUE CELL TRICH PSEUDORY AMINE OD GramInt (b)(6) Y THA Y Y Y N N BV Y N Y Y N N Y NL Y 0 Y Y N N Y BV Y 0 Y Y N N N BV N N Y N N N N BV Y THA Y Y Y N N BV Y 0 Y N N N N IN Y C Y Y N N Y BV Y 0 Y N N N N IN Y C Y N N N Y NL Y THA Y Y Y N Y NL Y 0 Y Y N Y Y BV Y THA Y Y N N Y BV Y 0 Y Y N N N BV Y THA Y Y Y N Y BV Y 0 N Y N N N BV Y C Y N N N Y BV Y THA Y N Y N N NL Y N N N N N N IN Y THA N N N N N NI, Y C N N N N N NL Y THA Y Y N N Y BV Y 0 Y Y N N Y BV Y N Y N N N N BV Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y 0 Y N Y N N BV Y N N N N N N IN Y 0 Y Y N N N BV Y THA Y Y N Y N BV Y 0 N Y N N N NL Y THA Y Y N N Y BV Y THA Y N N N Y IN Y 0 Y Y N N N NL 0 Y N N N Y NL Y THA Y N N N N NL Y THA Y N Y N Y BV Y N Y N N N N NL Y 0 N Y IN N N IN Y THA Y Y N N N -BV Y 0 Y Y N N N IN Y THA Y N N N N BV Y 0 N Y N N Y BV N N N N N N N NL Y N Y N N N N BV Y TRA Y Y N N N BV Y 0 Y Y N N N BV Y 0 Y Y N N N NL Y 0 Y Y N Y Y BV Y 0 Y Y Y N Y BV Y C N N N Y N NL Y THA Y Y Y N Y BV Y THA Y Y N N Y BV Y THA Y Y N N N IN Y THA Y Y N Y Y BV
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WK1 [email protected] or 301-796-8118 3.0>7 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Gardnerella vagrinalis
PATIENT ID GramSc GRAM GV BV DIAG 3/4 CAND DIAG TRICH DIAG GV CULT
(b)(6) 7 4 y N y 1 0 0 y N N I 8 3 y N N 2 10 4 y N N 2 10 4 N N N 2 a 3 y N y 0 6 2 N N N 0 10 4 y N N 2 5 2 N N N I 2 2 N y N 1 3 2 y N y 1 8 4 y y N 1 8 4 y N N 2 9 4 N N N 2 8 4 y N y 2 8 4 N N N 2 10 4 N N N 2 0 0 N N y 0 4 4 N N N 2 0 0 N N N 0 0 0 N y N 0 8 4 y N N 2 10 4 y N N 2 10 4 N N N 2 8 4 y N N 2 8 4 y N N 2 8 4 N N y 1 6 4 N N N 1 8 4 N N N 1 10 4 y y N 2 0 0 N N N 0 8 4 y N N 2 6 4 y N N 1 0 0 N N N 0 2 0 N N N 0 0 0 N N N 0 8 4 y N y 1 0 0 N N N 0 6 2 N N N 0 9 4 y N N 2 5 4 y N N 2 8 4 N N N 1 10 4 y N N 2 0 0 N N N 0 10 4 N N N 2 9 4 y N N 1 7 4 N N N 2 0 0 N N N 0 8 4 y y N 1 8 4 y N y 2 0 0 N y N 3 10 4 y N y 4 8 4 y N N 3 4 3 N x I N 2 10 4 y y I N 4
Questions? Contact FDA/CDRH/OCE/DID atV'P3LNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Gardner&lla vaginalls
PATIENT ID GV CULT QUAN PAC GV
(b)(6) 1000 1 20 0 10000 2 10000 3 10000 2 0 0 0 1 10000 3 10 1 40 0 10 0 100 1 10000 3 10000 3 10000 2 10000 3 10000 3 0 0 10000 1 0 0 0 0 10000 3 10000 1 10000 1 10000 3 10000 3 100 0 100 0 100 1 10000 3 0 0 10000 3 1000 2 0 0 0 0 0 0 32 0 0 0 0 0 10000 3 10000 3 1000 3 10000 1 0 0 10000 3 100 1 10000 3 0 0 1000 0 10000 0 1000:00 0 10000000 3 100000 3 10000 0 10000000 3
Questions? Contact FDA/CDRH/OCE/DID atVP31jNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vagrinalis
PATIENT ID SYMPTOM DISCHARGE PH > 4.5 CLUE CELL TRICH PSEUDOHY AMINE OD GramInt (b)(6) Y TRA Y Y Y N Y BV Y C N N N N Y BV Y C Y N N N N BV Y THA Y Y N N N BV Y N N N N N N NL N TRA Y Y Y N Y BV N C N N N Y N NL Y TRA Y Y N N Y BV Y THA Y Y N N Y BV Y C N N N Y N IN N N N N N N N NL Y C N N N Y N NL Y N Y Y N N Y IN Y F Y Y N N Y NL Y THA Y Y N N N BV Y THA Y Y N N Y BV Y N N N N N N NL N N N N N N N NL Y N Y Y N N Y BV Y THA Y N Y N N BV N N N N N N N NL Y THA Y Y N N Y BV N N N N N N N NL N N Y N N N N NL Y N Y Y N N Y BV N N Y N N N N BV Y N Y Y Y N N NL N 0 Y Y N N Y BV Y 0 Y Y N N Y BV Y THA Y Y N N Y BV Y THA N N N N N NL Y N N N N N N NL N N N N N N N NL N N N N N N N MT. Y TRA Y Y N N Y BV Y N N N N N N NL N N Y N N N N BV N N N N N N N NL Y N Y Y N N Y NL Y C N N N N N NL Y THA Y N N Y N NL N 0 Y Y Y N Y BV Y 0 N N N N N I Y TRA Y Y N N Y BV Y THA Y Y N N Y BV Y 0 Y N N N N NL Y N Y N N Y N -. NL Y TRA Y Y N N Y BV Y N N N N N N NL Y N Y Y N N Y BV Y THA Y Y N N Y BV Y TRA Y Y N N Y IN Y THA Y Y N N Y BV Y N N N N Y N NL N N N N N I Iq N NL 0 Questions? Contact FDA/CDRH/OCE/DID VP3LNLST.WK1 at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID GramSc GRAM GV BV DIAG 3/4 CAND DIAG TRICH DIAG GV CULT (b)(6) 8 4 y N y 3 7 4 N N N 3 10 4 N N N 0 9 4 y N N 3 0 0 N N N 0 10 4 y N y 3 0 0 N y N 0 7 4 y N N 2 7 4 y N N 3 6 4 N y N 3 0 0 N N N 2 2 2 N y N 0 4 4 y N N 3 0 0 y N N 2 8 4 y N N 3 7 4 y N N 3 3 3 N N N 0 0 0 N N N 0 8 4 y N N 3 8 4 N N y 2 0 0 N N N 0 8 4 y N N 3 0 0 N N N 0 0 0 N N N 0 8 4 y N N 3 7 3 N N _ N 2 2 0 N N y 0 a 4 y N N 3 7 4 y N N 4 10 4 y N N 3 0 0 N N N 1 0 0 N N N 1 0 0 N N N 0 0 0 N N N 0 10 4 y N N 2 1 1 N y N 0 8 4 N N N 3 0 0 N N N 0 0 0 y N N 0 0 0 N N N 0 0 0 N y N -1 10 4 y N y 3 0 0 N N N 2 10 4 y N N 3 10 4 y N N 2 0 0 N N N 0 0 0 N y N 0 10 4 y N N 2 0 0 N N N 0 10 4 y N N 2 8 4 y N N 3 5 3 y N N 2 9 4 y N N 3 0 0 N Y N 0 0 0 N_ N 0
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID GV CULT QUAN PAC GV
(b)(46) 100000 3 100000 3 0 1 100000 3 0 0 100000 3 0 0 10000 3 100000 3 100000 2 10000 0 0 0 100000 3 10000 1 100000 3 100000 3 0 0 0 0 100000 3 10000 0 0 0 100000 2 0 0 0 0 100000 3 10000 1 0 0 100000 3 10000000 2 100000 3 1000 0 1000 0 0 0 0 0 10000 3 0 0 100000 3 0 0 0 0 0 0 1000 1 100000 3 10000 1 100000 3 10000 1 0 0 0 0 10000 3 0 0 10000 3 100000 1 10000 2 100000 -3 0 0 0 -0
Questions? Contact FDA/CDRH/OCE/DID atVP31jNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalls
PATIENT ID SYMPTOM DISCHARGE PH > 4.5 CLUB CELL TRICH PSEUDOHY AMINE OD GramInt N N NL (b)(6) N N N N N N N N N N N N BV Y N Y Y N N Y BV N N N N N N N NL N N N N N N N NL N N Y Y N N N BV Y THA Y Y N N Y BV N N N N N N N NL Y 0 N N N Y N NL Y THA Y Y N N Y BV N N Y N N N N NL N N Y N N N N BV Y c N N N N N NL Y N N N N N N NL Y c N N N Y N NL Y THA Y Y Y N Y IN N c Y Y N N Y BV Y THA Y N Y N Y -IN Y THA Y Y N N Y BV N N Y N N N N IN N N N N N N N NL N N Y N N N N NL Y c N N N Y N BV N THA Y Y N N Y BV Y N Y Y N N Y BV N N N N N N N NL Y THA Y Y N N Y BV Y c N N N Y N NL Y TRA Y Y N N Y BV Y THA Y N N N N BV Y N Y N N N N BV Y THA Y Y N N Y BV Y 0 Y Y N N Y BV Y N N N N N N NL Y 0 N N N N N IN Y N N N N N N NL Y THA Y Y N N Y BV Y N N N N Y N NL N N N N N N N NL Y N Y Y N N Y BV N N N N N N N IN Y c N N N Y N NL N N N N N N N NL Y N N N N N N NL N N N N N N N NL Y THA N N N N N NL N N N N N N N NL Y c Y N N Y N IN Y N N N N Y N IN Y c N N N Y N IN Y 0 N N N N Y IN N N N N N N N NL N N Y y N N N BV Y THA Y Y N N Y BV N THA Y I I Y N N BV
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WY,l [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalls
PATIENT ID GramSc GPJUA GV BV DTAG 3/4 CAND DTAG TRICH DIAG GV CULT (b)(6) 0 0 N N N 0 8 4 N N N 3 10 4 y N N 3 0 0 N N N 0 0 0 N N N 0 9 4 y N N 3 10 4 y N N 3 0 0 N N N 0 1 0 N y N 2 8 4 y N N 3 1 0 N N N 0 8 4 N N N 0 0 0 N N N 0 1 0 N N N 1 1 0 N y N 1 4 3 y N y 2 7 4 y N N 4 4 2 y N y 2 7 3 y N N 3 5 3 N N N 3 1 0 N N N 1 1 0 N N N 0 9 4 N y N 3 7 4 y N N 2 8 4 y N N 3 1 0 N N N 0 10 4 y N N 2 0 0 N y N 1 10 4 y N N 3 7 3 N N N 2 7 4 N N N 2 9 4 y N N 2 10 4 y N N 3 1 0 N N N 0 5 2 N N N 3 0 0 N N N 2 9 4 y N N 3 1 1 N y N 1 0 0 N N N 1 8 4 y N N 4 4 3 N N N 0 0 0 N y N 2 0 0 N N N 0 0 0 N N N 0 0 0 N N N 0 0 0 N N N 1 0 0 N N N 0 6 4 N y N 3 4 0 N y N 2 4 3 N y N 0 6 4 N N N 2 0 0 N N N 1 9 4 N N N 4 10 4 y N N 4 10 4 N N y 3
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WK1 [email protected] or 301-796-8118 .1-1-11-111.1
Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID GV CULT QUAN PAC GV
(b)(6) 0 100000 3 100000 3 0 0 0 0 100000 3 100000 3 0 0 10000 0 100000 3 0 0 0 2 0 0 1000 0 1000 0 10000 1 10000000 3 10000 0 100000 2 100000 1 1000 0 0 100000 3 10000 3 100000 3 0 0 10000 3 1000 0 100000 3 10000 1 10000 -3 10000 2 100000 3 0 -0 100000 1 10000 0 100000 3 1000 0 1000 0 10000000 3 0 0 10000 0 0 0 0 0 0 0 1000 0 0 0 100000 1 10000 0 0 0 10000 2 1000 0 10000000 3 10000000 2 100000 2
Questions? Contact FDA/CDRH/OCE/DID atV'P3LNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID SYMPTOM DISCHARGE PH > 4. 5 CLUE CELL TRICH PSEUDOHY AMINE OD GramInt (b)(6) N N N N N N N BV Y N N N N N N IN Y N N N N N N BV Y THA Y Y N N Y BV N 0 y N N N N NL Y C Y N N Y N NL N N Y N N N Y BV Y THA Y Y N N N BV N N N N N N N NL Y THA Y N Y N Y BV Y N Y Y N N Y BV Y N N N N Y N NL Y 0 N N N Y N IN N N Y N N N N BV Y C N N N N N NL N N N N N N N NL Y THA Y Y N N Y BV Y N Y y N N Y BV N N N N N N N NL y THA Y N N N Y BV Y C Y N Y N Y BV N 0 Y Y N N Y BV Y C N N N N N NL N 0 Y N N N N BV Y N N N N Y N NL Y 0 N N N Y N NL N N N N N N N NL N THA Y Y N Y Y BV N N N N N N N NL Y N Y Y N N Y BV N N N N N N N NL N THA Y Y N N Y BV N N N N N N N NL Y THA Y Y N N N BV Y THA Y N N N Y IN Y C Y N N N N BV Y N N N N N N IN N N Y N N N N NL Y N Y Y N N Y BV Y THA Y Y N N Y IN Y 0 Y N N N N IN N N Y N N N N IN Y C N N N N N M Y N N N N N N NL Y 0 Y Y N N Y BV Y 0 N N N N N NL N N N N N N N BV N N N N N N N NL N N Y N N N N NL Y THA Y Y N N Y BV Y 0 Y N N N N BV Y N N N N N N NL N N N N N N N NL N THA N N N N N NL Y N N N N N N BV
Questions? Contact FDA/CDRH/OCE/DID atV'P3LNLST. [email protected] WKI or 301-796-8118 IN Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gatrdnerella vaginalis
PATIENT ID GramSc GRAM GV BV DIAG 3/4 CAND DIAG TRICH DIAG GV CULT
(b)(6) 7 4 N N N 3 4 4 N N N 3 a 4 N N N 3 9 4 y N N 3 0 0 N N N 0 0 0 N y N 0 10 4 N N N 3 10 4 y N N 3 0 0 N N N 0 9 4 y N y 2 9 4 y N N 3 0 0 N y N 0 4 3 N y N 3 10 4 N N N 3 0 0 N N N 2 0 0 N N N 0 9 4 y N N 3 10 4 y N N 3 2 2 N N N 2 10 4 y N N 3 10 4 N N y 3 10 4 y N N 3 2 2 N N N 1 10 4 N N N 3 0 0 N y N 0 0 0 N y N 0 0 0 N N N 0 7 4 y y N 4 0 0 N N N 0 8 4 y N N 4 0 0 N N N 0 8 4 y N N 3 0 0 N N N 0 8 4 y N N 4 5 3 y N N 2 8 4 N N N 4 5 3 N N N 2 0 0 N N N 0 8 4 y N N 4 5 4 y N N 4 6 4 N N N 4 4 4 N N N 4 0 0 N N N I 0 0 N N N 0 8 4 y N N 4 1 1 N N N 2 7 3 N N N 1 0 0 N N N 0 2 2 N N N 2 10 4 y N N 4 7 4 N N N 3 0 0 N N N 0 0 0 N N N 1 0 0 N N N 0 10 4 N N N 3
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPI,II 510(k) Submission Gardnerella vaginalis
PATiENT Gv CULT QUAN PAC GV 100000 0 (b)(6) 100000 0 100000 3 100000 3 0 0 0 0 100000 3 100000 3 0 0 10000 2 100000 3 0 0 100000 1 100000 3 10000 0 0 0 100000 2 100000 3 10000 0 100000 3 100000 3 100000 2 1000 0 100000 3 0 0 0 0 0 0 10000000 2 0 0 10000000 3 0 0 100000 3 0 0 10000000 3 10000 1 10000000 0 10000 0 0 0 10000000 3 10000000 2 10000000 2 10000000 3 1000 0 0 0 10000000 3 10000 0 1000 0 0 0 10000 1 10000000 3 100000 1 0 0 1000 0 0 ---0 r- 10 5 0 0 3
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID SYMPTOM DISCHARGE PH > 4.5 CLUE CELL TRICH PSEUDOHY AMINE OD GramInt (b)(6) Y THA N N N N N IN N N N N N N N NI, Y THA Y Y N N Y BV Y THA N Y N N Y NL Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y THA Y Y N N Y BV Y THA Y N N N N NL Y C N N N Y N NL Y THA Y Y N N Y BV Y THA N N N N N NL N THA Y Y N N Y IN Y 0 Y N N N N BV Y THA Y Y N N Y BV Y THA N N N N N IN Y 0 Y Y N N Y BV Y C Y Y N N Y NL Y THA Y Y N Y Y BV Y C Y N N N N NL Y THA Y Y N Y N BV Y THA Y Y N N Y BV Y THA N N N N N NL
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID GramSc GRAM GV BV DIAG 3/4 CAND DIAG TRICH DIAG GV CULT N N .0 (b)(6) 6 2 N 1 1 N N N 1 8 4 y N N 3 0 0 y N N 0 8 4 y N N 3 10 4 y N N 3 10 4 y N N 3 7 4 y N N 2 8 4 y N N 3 3 0 N N N 0 0 0 N y N 2 8 4 y N N 3 0 0 N N N 2 6 4 y N N 3 a 4 N N N 4 10 4 y N N 3 5 3 N N N 2 8 4 y N 3 0 0 y N N 0 8 4 y N N 3 0 0 N N N 2 8 4 y y N 0 10 4 y N N 4 3 0 N N N 0
Questions? Contact FDA/CDRH/OCE/DID atVP31,NLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Gardnerella vaginalis
PATIENT ID GV CULT QUAN PAC GV (b)(6) 0 0 0 1000 2 0 0 100000 2 100000 2 100000 3 10000 3 100000 3 0 0 10000 0 100000 2 10000 0 100000 3 10000000 3 100000 3 10000 0 100000 1 0 0 100000 3 10000 0 0 3 10000000 3 0
Questions? Contact FDA/CDRH/OCE/DID atVP3LNLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4
(b)(6) Y THA Y Y N N Y Y N THA Y Y Y N N Y Y 0 Y N N N N N Y F Y N Y N N N Y THA N Y N N Y Y Y Y Y N N Y Y Y THA N Y N N Y Y Y, c N N N Y N N Y THA Y Y N N Y y Y THA Y y N N Y Y N 0 Y N N N Y N Y c N N N Y N N Y THA Y N N N N N Y THA Y Y N N N Y N THA Y N Y N N N Y THA Y N N N N N N Y THA Y Y Y N N Y Y Y THA Y N N Y N N y 0 Y N Y N N N Y 0 N N N N N N Y THA N N N N N 'N Y N N N N N N N Y THA Y Y N N Y Y Y THA Y Y N N Y Y y N Y A N N N N N Y F Y Y Y N y Y Y c N N N N N N Y TRA Y Y N N Y Y Y 0 Y Y Y N N N y THA N N N N N N Y THA Y Y Y N Y Y y c N N N Y N N Y THA Y Y N N Y Y Y THA Y N N Y Y Y Y THA N Y N N Y Y Y THA Y Y N N N Y N N Y N N N N N Y F Y Y Y N y Y Y 0 Y N Y N Y N N F Y N N N N N Y THA Y Y N N Y Y Y c N N N N N N Y THA Y Y N N N Y Y c N N N Y N N Y 0 N N N N N N Y THA N N N Y N N Y THA Y Y Y N N Y Y N N N N N N N Y 0 Y Y N N N Y N N N N N N Y THA Y Y N N Y Y Y 0 N N N N N N 0 N N N N N N THA Y Y Y N Y Y Y THA Y L Y N Y N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT, ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N y 3 y 1 N N 0 N 0 N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 3 N N 0 N 0 N N 0 N 0 y N 0 N 0 N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 N N 0 N 0 N N 0 N 0 N y 2 N 0 N N 0 N 0 N y 3 y 1 y N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 0 y 1 N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 y N 0 N 0 N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 Y N 0 N 0
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 el %3 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 VP2CP1306 Y THA N Y Y N N N (b)(6) Y THA Y N N N N N Y TRA Y Y N N Y Y Y THA Y y N N Y Y Y 0 N Y N N Y Y Y c Y N N Y Y N Y c Y Y Y N Y Y N N N N N N N Y THA Y N N N - N N Y THA Y Y N N Y Y Y N N N N N N N Y 0 Y N Y N N N Y N Y N N N N N Y THA Y Y N N -Y Y Y c Y N N Y N N Y 0 Y N N N N N Y N N N N N N N Y 0 Y N N N N N Y N Y Y N N Y Y Y c N N N Y N N Y 0 N Y N N N N Y N N N N N N N Y THA Y y N N -Y Y Y N Y N N N N N Y THA Y N N N N N Y Y N 0 N N 7R- N N Y THA Y Y N N Y Y N N N N N N N Y c Y Y N Y Y Y N THA Y Y N N N Y Y THA Y N Y N N N Y 0 y Y N N Y Y Y TRA Y Y N N N Y Y N Y N N N N N Y 0 N N N N N N Y c N N N N N N Y THA Y N Y N N N Y TEA Y Y N N Y Y Y N Y N N N N N Y THA Y Y N N Y Y Y c N N N Y N N Y 0 Y N N N N N Y THA Y Y N N Y I Y Y THA Y Y N N N Y Y 0 N Y N N N N Y 0 N N N N N N Y N Y N N N N N Y 0 Y N N N Y N Y N Y N N N N N Y c Y N N Y N N Y 0 Y Y N N Y Y Y THA Y N N N Y Y Y 0 N N N N N N Y c y N Y N , N Y THA.---l N N N Y N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 N 0 N N 0 N 0 N N 3 y I y N 0 N 0 N N o N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 2 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 1 y 1 N N 0 N 0 N N 2 y 3 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N y 3 y 1 N N o N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 N N o N 0 N N o N 0 N N 0 N 0 y N o N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N I y 1 N N 0 N 0 N N o N 0 N N o N 0 y N o N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N o
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS TRICH PSEUDOHY AMINE OD BV -ýI-AG3/4 (b)(6) N N Y N N N N N Y THA Y N N Y N N Y THA Y N N N N N Y F N Y N N N N THA Y N N Y N N Y C Y N N N N N Y C N N N N N N Y THA Y N N N N N N N Y Y N N Y Y N THA Y N N N N N N 0 N N N N N N Y C Y N N N N N Y C Y Y N N Y Y Y 0 N N N N N N Y C N N N N N N Y N Y N N Y N N Y N N N N N N N Y Y N N Y Y Y C N N N N N N Y 0 N N N N N N Y c N N N N N N Y C Y N N N N N Y 0 Y N N N N N Y THA Y Y N N Y Y Y THA Y N N N N N Y c Y N N Y N N Y THA N N N N N N N C N N N N N N N THA Y N N N N N N C N N N Y N N Y F Y N Y Y N N Y N Y N N N N N Y THA N N N N N N Y THA Y Y N N Y Y Y THA N N N N N N Y 0 Y N N N N N Y 0 Y N Y Y N N Y F Y N N N N N Y THA Y N N Y N N Y 0 Y N N Y N N N 0 N N N N N N Y 0 Y Y N N Y Y Y 0 N N N N N N Y THA Y Y N N Y Y Y THA N Y N N Y Y Y THA N Y N N N N Y TRA N Y N N Y Y Y THA N N N N N N N THA N N N N N N THA N N N N N N Y THA Y N N N N N Y C Y Y N Y N -N Y 0 Y N N N N N N C N N N N N N N N Y N Y N N N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission TrIchomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 y N 0 N 0 N N 0 N 0 N y 3 y 1 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 y y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y y 3 y 3 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N y 2
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 (b)(6) Y 0 Y N N N N N Y F Y N N N N N Y Y Y N N Y Y Y C Y N N Y N N Y 0 N N N N N N N N N N N N N N Y THA N N N N N N Y 0 N N N N N N Y THA N N N N N N N THA Y Y N N Y Y N 0 Y N N N N N Y THA Y N N Y N N Y C N N N N N N Y 0 Y N N N N N Y 0 Y N N Y N N Y 0 Y N N N N N N C N N N N N N Y C Y Y N N Y Y Y C N N N Y N N Y 0 Y N N Y N N Y 0 N N N N N N Y C Y N N Y N N N N N N N Y N N N N N N N N N N N THA N N N N N N N THA N N N N N N Y THA Y N N N N N Y C N N N Y N N Y THA N N N N N N Y C Y N N N N N Y C Y N N N N N Y C Y N N Y N N Y F Y N Y N N N Y N Y N N N N N N N N N N N N N Y C Y N N Y N N Y THA N N N N N N N 0 Y N N N N N N 0 Y N N N N N N N N N N Y N N N 0 N N N N N N Y C N N N Y N N Y Y N N Y N N Y C N N N N N N Y C N N N N N N N THA Y N N N N N N THA Y N N N N N Y N N N N N N N Y THA Y Y N N Y Y Y C N N N Y N N Y THA Y N N N N N N THA N N N N N N Y Y N N N Y N Y Y N N N N N Y N Y Y N N -Y Y
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vayinalia
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N y 2 y 1 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI. [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PHA.5 CLUE CELLS- TRICH PSEUDOHY AMINE OD BV DIAG 3/4 (b)(6) Y TRA Y Y N N Y Y Y THA Y Y N Y Y Y Y THA Y N N N N N Y THA Y Y N N Y Y Y C N N N Y N N N N Y Y N N Y Y Y C Y N N Y N N N C Y N N N N N Y 0 Y N N N N N Y TRA Y N N N N N Y THA Y Y N N Y Y Y C Y N N N N N Y THA Y N N N N N Y THA N Y N N Y Y Y THA Y N N N N N Y N N N N N N N Y C Y N Y Y N N Y C N N N Y N N Y C N N N N N N Y C N N N N N N Y THA Y Y N N Y Y Y C N N N N N N Y 0 N N N N N N Y C N N N Y N N Y THA Y Y N N N Y Y THA y Y N N Y Y Y C N N N N N N Y F Y N N N N N Y TRA Y Y Y N Y Y Y C N N N Y N N Y C N N N N N N Y TRA Y Y N N Y y Y THA Y Y N N Y Y Y C N N N Y N N Y THA Y Y N N Y Y Y THA N Y N N N Y THA Y Y N N N Y Y THA Y Y N N N Y Y 0 Y Y N N -N N Y THA N N N N N N Y C N N N N N N Y THA N N N N N N Y N N N N N N N Y C N N N N N N Y TRA Y Y N y Y Y Y N N N N N N N Y THA Y Y N N N Y Y THA Y Y N N Y Y Y THA Y N N N N N Y TRA Y Y N N Y Y Y, Y THA Y N N Y Y N' Y 0 N N N N N Y C N N N Y N N Y THA N NI N N Y N Y j F Y N Y -1 N N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y y 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 y 5 N y 3 y 2 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 0 N N 0 0 N Y 3 y 3
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 (b)(6) Y THA Y Y N N Y Y Y C N N N N N N Y C N N N N N N Y THA Y Y N N Y Y Y 0 Y N N N N N Y THA N N N N N N Y THA Y N N N N N Y N N N N N N N Y C N N N Y N N Y C N N N N N N Y N N N N N N N N N N Y N N N N Y 0 Y N N N Y N N N N N N N N N Y C N Y N N N N Y 0 N N N N N N N N N N N N N N N N Y Y N N N N Y C N N N N N N N 0 N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N Y N N N N N N N Y F Y Y N N Y Y Y 0 N N N N N N N N N N N N N N Y C Y Y N N Y Y N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N Y THA Y Y N N N Y Y 0 N N N N N N N N N N N N N N N N N N N N N N N i N N N N N N N 0 9 N N N N N N Y C N N N N N N N N N N N N N N Y THA Y Y N N Y Y Y C N N N N N N Y THA Y Y N N Y Y Y THA Y Y N N Y Y Y C N N N Y N N Y C N N N Y N N N N N Y N N N N y N N N N N N N Y N Y Y N N N N N N Y N N Y N N Y N Y N N N N N Y C N N N Y N N y N N N N N N N Y THA Y Y N N Y Y-
5troo Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 L--- ýý
Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N L 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 1 y 7 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 3 y 3 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 1 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 x 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118 " ON, Lo!ý Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
SYMPTOM; AMINE OD BV DIAG 3/4 PATIENT ID DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY (b)(6) Y THA Y Y N N Y Y Y Y THA Y Y N N Y Y THA Y Y N N N Y N 0 Y Y N N N N N 0 N N N N N N Y TRA Y Y N N Y Y Y N N N N N N N Y 0 N N N N N N Y THA Y Y N N Y Y Y 0 N N N N N N Y TRA Y Y N N Y Y N N N N N N N N Y THA Y Y N N Y Y Y N N N N N N N Y 0 N N N N N N Y 0 N N N Y N N Y 0 N N N N N N N THA Y Y N N Y Y Y 0 Y Y N N Y Y Y c N Y N Y N N Y TRA Y Y N N N Y N N N N N N N N Y 0 N N N N N N Y 0 Y Y N N N N Y N N N N N N N Y 0 N N N Y N N Y c N N N Y N N Y c N N N N N Y 0 N N N N N N Y N N N N N N N Y c N N N Y N N Y THA N Y N N N N Y THA Y Y N N Y Y Y 0 N Y N N N N Y 0 Y Y N N Y Y N 0 N N N N N N Y 0 Y Y N N Y Y N N N N N N N Y N N N N N Y c Y Y N N N N Y N N N N N N Y N N N N N N N Y 0 N N N N N N Y 0 N N N N N N Y 0 Y N N N N N Y 0 Y Y N N N N Y N N N N N N N Y 0 Y N N N N N Y THA Y Y N N Y Y Y F Y N Y N N N Y 0 Y Y N N N N Y 0 N Y N N N Y THA Y Y N N Y Y Y 0 N Y N Y N N Y 0 N N N Y N N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKl [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG DIAG_j PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 N N 0 y 4 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 y 3 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 1 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 2 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 Y N 0 N 0 000000 Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118flký Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
BV D IAG 3/4 PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD (b)(6) y 0 N N N N N N y 0 y N N y N N y C N N N y N N y 0 y N N N N N y 0 N N N y N N y 0 N N N y N N N N N N N N N N N N N y N N y N N N y y N N y y N N N N N N N N N N y y N N y y y N y y N N y y y N N N N N N N N N N N N N N N N N N N N N N N N N N y N N N N N N N N N N N N N N N N N N N N N THA y y N N y y y TRA y y N N N y N C N y N N N N N N y N N N N N N N N N N N N N N N N N N N N y N N N N N N N N N N N N N N N N 0 N N N N N N N N N N N N N N N N N N N N N N N N N N N N N y 0 y y N y y y N N N N N N N N N N N N N N N N N N N N N N N N y C N N N y N N N N N N N N N N N N y N N N N N y N N N N N N N y N N N N N N N N N y y N 14 N N y THA y y N N y y N N y N N N N N N N N N N N N N y 0 y y N N y y N THA N N N N N N N N N N N N N N N N y N N N N N N N N y N N y N y N y y N N y y N F y y N N N N N N N N N N N N N N N N N N N N N 0 y y N N N N N N N N N N N N N N N N N N
Questions? Contact FDA/CDRH/OCE/DID atV'P3TVLST.WKI [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N N N 0 N 0
Questions? Contact FDA/CDRH/OCE/DID atV'P3TVLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUB CELLS- TRICH PSEUDOHY AMINE OD BV DIAG 3/4 (b)(6) N N N N N N N N N N N N N N N N N N N N N N N N Y THA Y Y N N N Y N N N N N N N N N N N N N N N N N' N N N N N N N N N N N N N N N Y C N N N Y N N Y N N N N N N N N N N N N N N N N N Y N N N N N Y THA Y Y N N Y Y N 0 N N N N N N N N N N N N N N Y N N N N N N N Y THA Y Y N N Y Y Y C N N N N N N N C N N N N N N N N N N N N N N Y THA Y Y N N Y Y N N Y N N N N N N N N N N N N N N N N N N N N N N N N N N Y N N N N N N N N N N N N N N N N N N Y F Y Y N N Y Y N N N N N N N N N N N Y N N N N Y THA Y Y N N Y Y Y 0 N N N N N N N C N N N N N N Y THA Y Y N N Y Y N N N N N N N N N N Y N N N Y N Y 0 N N N N N N N N N N N N N N N N N N N N' N N N N N N N N N N Y THA Y Y N N Y Y N N N N N N N N N C N N N N N N N' N N N N N N N Y C N Y x N N N N N N N N N N Y, N- Y TRA N N N N N Y F Y Y Y N Y Y Y THA Y 'Y N N Y Y Y THA Y Y N N Y Y N N N N N N N N N N Y N N N N N N N N N N N N N N N N N N N N N N THA Y Y N N Y
Questions? Contact FDA/CDRH/OCE/DID atV'P3TVLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 3 y 3 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 x y 3 y 3 N N 3 y 3 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Trichomonas vaginalis
3/4 PATIENT ID SYMPTOM DISCHARGE PH>4. 5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DI,AG (b)(6) y N N y y N N y y THA y y y N N y y C y y y y y y y N N N N y N N y THA y y N N N y y N y N N N N N y THA y y N N y y y THA y y y N y y y TEA y N y N N N y THA N y y N N N y THA y y y N y y y C N N N N N N y THA y y y N N y y THA y y N N y y y THA y N y N N N y THA y y N N y y y N y N y N N N y TRA y y y N y y y TRA y y y N y y y THA y y y N N y y THA y N y N N N y 0 y N y N N N y THA y y y N y y y THA y y y N y y y C y y y N y y y THA y y y N y y y THA y y y N y y y THA y y y N y y y C x N N N N N y THA N N N N N N y TRA y y N N y y y C y N N y N N y C y y N N y y y THA y y N N y y y THA y y N N y y y THA y y y N N y y C N N N N N N y THA y y y N y y y THA y y y N N y y TRA y N y N N N y THA y y y N y y y THA y N y N N N y C y y N N N N y THA y y N N y y y THA y y N N y y y TRA y y y N y y y THA y y y N y y y C y y N N y y y THA N N y N N N y C y N y N N N y THA y y N N y y y N N N N N N N Y THA N N N N N N y THA y y y N y y C y y y N Y y
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N y 3 y 1 y y 3 y 1 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 N y 3 y 1 N y 3 y 1 N y 3 y I N N 0 N 0 N N 3 y I N N 0 N 0 N y 3 y I N N 0 N 0 N y 3 y 1 N y 3 y I N y 2 y 1 N y 3 y 1 N y 3 y I N y 1 y 1 N y 2 y I N y 0 N 0 N y 0 y 1 N y 3 y 1 N y 2 y 1 N y 3 y 1 N 14 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 N N 0 N 0 N y 3 y 1 N y 3 y 1 N y 3 y 1 N y 3 y I N y 1 y 1 N N 0 N 0 N y i y 1 N N 0 N 0 N y 1 y I N y 3 y 1 N N 0 N 0 N y 3 y I N y 2 y 1 N N 0 N 0 N N 0 N 0 N N 1 y 1 N y 2 y 1 N y 3 y I
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 a-5 I Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
vpiii 510(k) Submission Trichomonas vagrinalis
AMINE OD BV DIAG 3/4 PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY (b)(6) Y THA Y N N N N N Y 0 Y Y Y Y Y Y Y THA Y Y N N Y Y Y THA Y N Y N N N Y THA Y Y Y N Y Y Y THA Y Y Y N Y Y Y THA Y Y Y N Y Y Y THA Y Y Y N Y Y -Y THA Y Y Y N Y Y Y THA Y Y Y N Y Y Y THA Y Y Y N Y Y Y THA Y Y N Y Y Y THA Y Y N N Y Y Y C Y Y N N Y Y Y THA Y Y Y N Y Y Y THA Y Y N N Y Y Y C Y Y N N Y Y Y THA Y Y N N Y Y Y THA Y Y N N Y Y N THA Y N Y N N N Y THA Y N Y Y N N Y THA Y Y N N Y Y Y THA N Y Y N Y Y Y C N N N Y N N Y C N N N N N N Y N Y N N N Y THA Y Y N N Y Y Y THA Y Y N N Y Y Y THA Y Y N N Y Y Y N N N N N N Y THA Y Y N N Y Y Y THA N N Y Y N N Y THA Y Y N N Y Y Y THA N Y N N N N Y C Y Y Y N Y Y N N Y N N N N N Y THA N N N N N N Y THA Y Y N N Y Y Y THA Y Y N N Y Y Y THA Y Y N N Y Y Y N Y Y N Y Y Y Y THA Y Y N Y Y Y THA Y Y N N Y Y Y THA Y Y N N Y Y N C N N N Y N N Y THA Y Y N N N Y Y THA Y N Y N N N Y TRA Y Y N N Y Y Y C Y Y N N Y Y Y THA Y Y N N Y Y Y TEA Y N N N N Y THA Y Y N N Y Y Y 0 Y Y Y N Y Y Y C N N Y N Y N Y C Y Y Y N Y Y
%0 Questions? Contact FDA/CDRH/OCE/DID atV'P3TVLST. [email protected] W'Kl or 301-796-8118 aý 1 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalls DITG- PATIENT ID CA DIAG TR PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 y y 0 y 1 N N 0 N 0 N y 3 y 1 N y 3 y I N y 3 y 1 N y 0 y 1 N y 2 y 1 N y 3 y 1 N y 3 y 1 N y 3 y 1 N y 3 y 1 N N 0 N 0 N N 0 N 0 N y 2 y I N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 y y 3 y I N N 0 N 0 N y 2 y I y N 0 N 0 N N 0 N 0 N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y y 3 y 1 N N 0 N 0 N N 0 N 0 N y 2 y 1 N N 0 N 0 N N 0 y I N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 y 2 N N 0 N 0 y N 0 N 0 N N 1 y 2 N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 N y 3 y N y I
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4. 5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 (b)(6) N N N N N N N N N N N N N N N Y C Y N N Y N N N N Y Y N N N N N TRA Y N N N N N Y THA N N N N N N N N Y N N N Y N Y THA Y Y N N Y Y Y N N N N N N N Y THA N Y N N N N y N Y Y N N Y Y Y C N N N Y N N Y THA Y Y Y N Y Y Y THA N N N N N N N TRA N N N N N N y TRA Y Y Y N N Y Y N N N N N N N Y THA Y Y Y N Y Y Y 0 Y N N N N N Y THA N N N N N N Y THA Y Y N N Y Y N N N N N N N N N THA Y Y N N Y Y Y THA Y Y N N Y Y N THA N N N N N N N N N N N N N N N C N N N Y N N N F Y N Y N N N Y THA Y Y N N Y Y N THA Y Y N N Y Y Y C N N N Y N N Y THA Y Y N N Y Y Y TRA y Y N N Y Y N THA N N N N N N N TRA N N N N N N N TRA Y Y N N Y Y Y THA Y N N N Y Y N N Y N N N N N Y THA Y Y N N Y Y N N N N N N N N N N Y N N N Y N N C N N N N N N N N N N N N N N N c N N N N N N N N N N N N N N Y THA Y Y Y N Y Y y 0 Y N N N Y N Y TRA Y N N N N N Y THA Y Y N N Y Y Y TRA Y N N Y N N Y THA Y Y N N y Y N N N N N N N N N N N N N N N N Y 0 N N N N N N F N N N -N Y N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118 17 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) SubmiBsion Trichomonas vagrinalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N o N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N y 2 y 1 N N 0 N 0 N N 0 N 0 N y 1 y 1 N N 0 N 0 N y 1 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N o N 0 N N o N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N y 3 y I N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 1 y 1 N N o N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N o
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYlAPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3/4 (b)(6) y 0 y y y N y y N C N N N N N N y TRA y y y N y y y C y N N y N N y TRA N y N y y y y C N N N y N N N N N N N N N N N N N N N N N N N THA y N N N N- N Y THA y y N N y y N N N N N N N N y C N y N N N N y THA y N N N N N N N N N N N N N y THA y y N N y y y C N N N N N N y C N N N N N N N THA y y N N y y N N N N N N N N y THA y y N N y y y C y y N N y y y C N N N N N N y C N y N y N N N C y y N N y y y C N N N N N N N N N y N N y N N THA N N N N N N y THA y y N N y y y C N N N y N N y N N N N y N N N N N N N N N N N THA y y N N y y N N N N N N N N N N N N N N N N y C N N N N N N y C N N N N N N N N N N N N N y C N N N N N N N N N N N N N N y THA y y N N y y N C N N N N N N y C y N N y N N y THA y y N N y y y C y y N N y y y C N N N y N N N C N N N N N N y C N y N N y y N 0 y N N N N N y C N N N y N N y C y y N N y y N C y y N N y y y THA y y N N y y y C y y N y y y N N N N N N N N Y THA N N N N N N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 L.- - ý,
Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N y 3 y 1 N N 0 N 0 N y 3 y 1 y N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N 0 N 0
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WKI [email protected] or 301-796-8118 031 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichamonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSHUDOHY AMINE OD BV 76IAG 3/4 (b)(6) y THA y y N N y y y THA N y N N N N y THA y y N N N y y c N N N N N N N TRA N N N N N N N THA y N N N N y THA y N N N N N y 0 y y N N y y y N y N N N N N N N a N N N N N N y 0 y N N N N N N N N N N N N N y c N N N y N N N 0 N N N N N N y THA y N N N N N N THA y y N N N y N THA N N N N N N N N N N N y N N y N y y N N y y N N N N N N N N y THA N N N N N N N TRA y y N N y y y THA y y N N y y N c N N N N N N y THA y y y N y y y c N N N y N N N N N N N N N N y N N N N N N N y c y N N N N N N N y y N N N N y N N N N N N N N N y y N N N N 'N N y y N N y y y 0 y y N N y y N 0 y N N N N N y c y y y y y y N THA N N N N N N N THA y y y N y y N N N N N N N N y THA y y N N y y N THA y y N N y y y 0 y y N N y y y THA y y N N N y y c N N N N N N N N N N N N N N y THA y y y N y y y TRA N N N N N N N N N N N N N N N THA N N N N N N N c N N N N N N y N N N N N N N y THA y y N N y y N 0 N N N N N N y N N N N N N N Y c N N N N N N
Questions? Contact FDA/CDRH/OCE/DID atV'P3TVLST.WKI [email protected] or 301-796-8118
It Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 1 y 1 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y y 3 y 4 N N 0 N 0 N y 3 y I N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 2 y I N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N N 0 N N 0 N 0 Aft Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118f3lT Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV DIAG 3 /4 (b)(6) N c N N N N N N Y THA N N N N N N Y THA Y Y N N Y Y Y THA Y Y N N Y Y Y N Y N N N Y N N N N N N N N N N THA Y Y N N Y Y N 0 y N Y N N N N 0 N N N N N N Y THA Y Y N N Y Y Y 0 Y Y N N Y Y Y F - I Y y N Y N N THA Y N N N N N N N N N N N N N Y N N N N Y N N Y c Y N N N N N N N N N N N N N N 0 Y Y N N N N N N Y Y N N N N Y 0 N N N N N N N 0 Y N N N N N N THA N N N N N N N THA N N N N N N N N Y Y N N N N Y c N N N N N N Y THA N N N N N N Y THA Y N y N N N Y c Y Y N N Y Y Y N N N N N N N Y THA N N N N N N Y c Y N N N N N N 0 Y N N N N N Y THA Y Y N N Y Y Y THA y Y N N Y Y N F Y N N N N N N N N N N N N N N N N N N N N N Y c N N N N N N N N Y N N N N N Y c Y Y N N N Y N THA Y Y Y N y Y N THA Y Y Y N Y Y N N N N N N N N N 0 Y Y N N Y Y N N N N N N N N Y c Y Y N Y N N N THA Y Y N N Y Y N N N N N N N N N THA N N N N N N N 0 Y Y Y N Y Y N 0 Y Y N N N N N N N N N N N N Y c N N N Y N N Y THA Y Y N -N Y Y I N I c I N N -i -F N N N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118
*"F Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 2 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 3 y 1 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N y 3 y 1 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 2 y 1 N y 1 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N a N y 3 y 1 N N 0 N 0 N N 0 N 0 y N 0 N 0 N N 0 N 0 N 0 N -0-1
AIL Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118 rul jrc Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
VPIII 510(k) Submission Trichomonas vaginalls
PATIENT ID SYMPTOM DISCHARGE PH>4.5 CLUE CELLS TRICH PSEUDOHY AMINE OD BV D IAG 3 4
(b)(6) N C N N N N N N y THA y N N N y y N 0 N N N N N N y TRA y y N N y y y THA y y N N y y y F y y N N y y y THA y N N N N N y THA y y N N y y y 0 N N N y N N y F N N y y N N N THA N N N y N N y C N N N y N N y N N N N y N N N 0 N N y N N N C N N N N N N N N N N N N N N N THA y N N N N N N N y y y N y N 0 y N N N N N y N N N N N N N y THA y y N N N y N N N N N N N N N F y N N N N N N N N N N N N N N C N y N N y N Y 0 N N N N N -N
Questions? Contact FDA/CDRH/OCE/DID atVP3TVLST.WK1 [email protected] or 301-796-8118
j Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016 VPIII 510(k) SubmiBSion Trichomonas vaginalis
PATIENT ID CA DIAG TR DIAG PAC TR TR CULTURE DAY POS (b)(6) N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N o N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 y N 0 N 0 y y 0 y 5 y N 0 N 0 y N 0 N 0 y N 0 N 0 y N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N y 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N 0 N N 0 N N N 0 N
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 DEPARTMENT OFRecords HEALTH processed AND HUMAN under SERVICES FOIA # 2016-3957; ReleasedPublic by CDRH Health on 11-22-2016 Service
Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (BFZ-401) 1390 Piccard Drive Rockville, Maryland 20850 mn'v'./ 'ý"
MICROPROBE CORP. 510(k) Number: K931374 1725 220TH ST. S.E., #104 Trade Name: AFFIRM VPIII BOTHELL, WA 98021 MICROBIAL ATTN: RUSSEL K. ENNS IDENTIFICATION TEST Regulatory Class: 1 Dated: 16-MAR-93 Received: 18-MAR-93 Cleared: 15-JUN-93 CLIA COMPLEXITY: CDC ANALYTE IDENTIFIER CODE: CDC TEST SYSTEM (SEE ATTACHED) IDENTIFIER CODE:
On February 28, 1992, the Department of Health and Human Services (HHS) published the final laboratory standards regulation (57 FEDERAL REGISTER 70002) implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (codified at 42 CFR Part 493). The final laboratory standards regulation establishes three levels of testing complexity: 1) waived tests, 2) moderate complexity tests, and 3) high complexity tests (42 CFR Part 493.10). Laboratories performing only waived tests are subject to minimal regulation. Laboratories performing moderate or high complexity tests are subject to specific laboratory standards pertaining to certification, personnel, proficiency testing, patient test management, quality assurance and QC, and inspection.
For the purposes of implementing CLIA Test Categorization (42 CFR 493.17), the subject device of the above referenced 510(k) has been assessed for its CLIA complexity category. The Centers for Disease Control and Prevention (CDC) and FDA in a joint review have determined the following complexity category for the above referenced device:
Does not require categorization
Waived (SEE ATTACHED) Moderate I I High
Retains the original complexity category assigned. The modification described in the submission does not change the assignment.
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
Page 407 redacted for the following reason: ------(b)(4)
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA # 2016-3957; Released by CDRH on 11-22-2016
The CDC Identifier Code(s) referenced above are unique identifiers developed by CDC to facilitate the data management. They can be used by CDC, FDA, the Health Care Financing Administration (HCFA), laboratories and health insurers to track an assay's complexity category. Please include this(ese) code(s) along with the complexity category in the labeling. 21 CFR Part 809.10(b)(5((ii) of the labeling regulation requires manufacturers to include limiting statements appropriate to the intended use of the product in the labeling and it is appropriate to include the complexity information in this section. However, to facilitate the ability of laboratories and HCFA laboratory surveyors to locate the assigned complexity category and Identifier Code(s) in the device labeling, FDA requests that the manufacturer also provide this information on the front cover of the labeling.
This complexity category assessment is effective as of the date of this notification. The information has been added to the CDC complexity category database. At a future date, CDC will also publish an update to their previously published complexity list in the FEDERAL REGISTER. This mechanism is to ensure that the public has been properly notified of the complexity categories of new test systems.
For general questions regarding FDA's categorization procedure, please contact the Division of Small Manufacturers Assistance at their toll-free number (800) 638-2041, or at (301) 443-6597.
Sincerely yours,
Steven I. Gutman, M.D. Acting Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118