U.S. Department of Health & Human Services

Records processed under FOIA Request 2014-5115; Released 10/15/14

Food and Drug Administration

SAVE REQUEST

USER: (ldt) FOLDER: K933121 - 50 pages COMPANY: BIOCLINICAL SYSTEMS, INC. (BIOCSYST) PRODUCT: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (JTY) SUMMARY: Product: MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

DATE REQUESTED: Oct 8, 2014

DATE PRINTED: Oct 8, 2014

Note: Printed

5600 Fishers Lane, HFI-35, Room 6-30, Rockville, MD 20857

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510(x) ROUTE SLIP

510(k) NUMBER K933121 PANEL MI DIVISION DCLD BRANCH

TRADE NAME MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

COMMON NAME

PRODUCT CODE

APPLICANT BIOCLINICAL SYSTEMS, INC. SHORT NAME BIOCSYST CONTACT KATHRYN POWERS DIVISION ADDRESS 9040 JUNCTION DR. SUITE ONE ANNAPOLIS JUNCTION, MD 20701 PHONE N0. (301) 498-9550 FAX NO. (301) 470-4129

MANUFACTURER BIOCLINICAL SYSTEMS, INC. REGISTRATION NO. 1120183

DATE ON SUBMISSION 25-JUN-93 DATE DUE TO 510(x) STAFF

DATE RECEIVED IN ODE 2 - 3 DATE DECISION DUE 23-SEP-93

DECISION DECISION DATE

d 1 ý. U

PPLEMENTS SUBMITTED RECEIVED DUE POS DUE OUT

SUPP001 24-AUG-93 25-AUG-93 08-NOV-93 23-NOV-93

OUT GOING CORRESPONDENCE

SUPP001 18-AUG-93 17-SEP-93 ') C n r rr n I 1115---ý r-P

;. . FEB- 7 1994

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 SEAp(, OtA'H (1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ýK oNbYdla Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Phil Buckner HealthLink 3611 St. Johns Bluff Road South Suite 1 Jacksonville, FL 32224

Re-'31124 Microbiological Culture Media, Chocolate Agar

K933122 Microbiological Culture Media, Martin Lewis Agar

K945911 Culture Media, Antimicrobial Susceptibility Test

K950196 Culture Media, for Isolation of Pathogenic Neisseria

Dear Mr. Nickel:

We have reviewed your letters, dated August 25, 1998, stating that the rights to the above referenced premarket notifications (510(k)s) have been transferred. Transfer of 510(k) rights alone does not require submission of a new 510(k) under 21 CFR 807.81(a)(3). Consequently, we can not change the name of the original 510(K) submitter in our database. We suggest that information showing the transfer of the 510(k) and their current ownership should be maintained in your files for review by an FDA investigator. You may contact the Center for Devices and Radiological Health's Office of Compliance at (301) 594-4692 if you have any questions on what information we expect to be maintained in your files.

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Page 2 - Mr. Buckner

If you have any other questions regarding this letter, please contact the 510(k) staff at (301) 594-1190.

Sincerely yours,

Heather S. Rosecrans Chief, Premarket Notification Section Program Operations Staff Office of Device Evaluation Center for Devices and Radiological Health

Cc: BioClinical Systems 9040 Junction Drive Suite 1 Annapolis Junction, MD 20701

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Memorandum

Date: 41JAff

From: Document Mail Center (IiFZ-401)

Subject: Premarket Notification Number(s):

To: Division Director: --

The attached information has been received by the 510(k) Document Mail Center (DMC), on the above referenced 510(k) submission(s). Since a final decision has been rendered, this record is officially closed.

Please review the attached document and return it to the DMC, with one of the statements checked below. Feel free to note any additional comments below.

Thank you for your cooperation.

Information does not change status of the 510(k); no other action required by the DMC; please add to the image file. [THE DIVISION SHOULD PREPARE A CONFIRMATION LETTER - AN EXAMPLE IS AVAILABLE ON THE LAN (K25). THIS DOES NOT APPLY TO TRANSFER OF OWNERSHIP. PLEASE BRING ANY TRANSFER OF OWNERSHIP TO POS.]

Additional information requires a new 510(k) however the information submitted is incomplete. Notify the company to submit a new 510(k). [THE DIVISION SHOULD PREPARE THE (K30) LETTER ON THE LAN.

Additional information requires a new 510(k)please process. [THIS- WILL BE MADE INTO A NEW 510(k)]. -INFORMATION

No response necessary (e.g., hard copy of fax for the truthful and accuracy statement or 510(k) statement).

This information should be returned to the DMC within 10 working days from the date of this memorandum.

Reviewed by:

Date:

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3611 St. Johns Bluif Rc>ad outh Suite 1 ealthUn Jack,onville, Florida 32224 A Family of Medical Products

['hone: (904) 996-7758 Fax: (904) 996-7078

Tuesday August 25, 1998

Office of Device Evaluation Division of Clinical Laboratory Devices -14FZ-440 Food & Drug Administration 2098 Gaither Rd. Rockville, MD 20850

Dear Sirs:

Please allow this letter to serve as notice that the following 510 (k) number has been purchased.

510 (k) number Device description K933121 Microbiological culture media, Chocolate Agar

- This 510 (k) originally submitted by BioClinical Systems is now owned by HealthLink 3611 St. Johns Bluff Road South, Suite 1, Jacksonville, FL 32224, Phone (904) 996-7758, Fax (904) 996-7078.

Thank you for your assistance in these matters. Please feel free to call me at (90'996-7758 if you have any further questions.

Sincerely,

Phil Buckner HealthLink

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 f,ýSItVICft.L1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration FEB 3 1994 1390 Piccard Drive Rockville,MD 20850

Ms. Kathryn Babka Powers Re: K933121/S1 Regulatory Affairs Product: Microbiological Culture Media, BIOCLINICAL SYSTEMS, INC. Chocolate Agar "For growth and isolation of 9040 Junction Drive microorganisms only" Suite One Dated: August 24, 1993 Annapolis Junction, MD 20701 Received: August 25, 1993 Regulatory Class: II Dear Ms. Powers:

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 Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual 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 Federal Register. 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 to 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 approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If you desire specific advice on the labeling for your device please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at (301) 594-4639. 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) 44.3-6597.

Sincerely yours,

Steven I. Cutman, M.D., M.B.A. Acting Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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DO NOT REMOVE THIS ROUTE SLIP!!!!

K-93-3121 7/8/93

FROM: LETTER DATE LOGIN DATE DUE DATE BIOCLINICAL SYSTEMS, INC. I 06/25/93 I 06/25/93 I 09/23/93 ATTN: KATHRYN POWERS JUNCTION DR. (TYPE------I------9040 OF DOCUMENT: (CONTROL # SUITE ONE I 510(k) I K933121 ------ANNAPOLIS JUNCTION, MD 20701 I PHONE N0: 301-498-9550 I eHORT NAME: BIOCSYST ESTABLISHMENT NO: 1120183 _________-______ _ __I ______-ýCONT.____CONT. :CONE ý ODE/DMC STATUS : R (REV PANEL : MI IPA-/PROD CODE(-): I g I_S ? MI/--____/-_____/____I______ SUBJECT: MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR ______I DECISION: I-RQST INFO DATE: / / (INFO DUE DATE: / / DECISION DATE: DATE: / DATE: DATE: / / I DATE: / / I I DATE: / / DATE: / / DATE: / / I DATE: / / I I DATE: / / I DATE: / / I______ý______I

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Cýr_ 17 Date 1n-"or`t I

- REVIEWER(S) NAME(S) AM - C*'t-ýr

Subject 510(k) NOTIFICATION 11 -- -K

r To THE RECORD `

It is my recommendation that the subject 510(k) Notification: V"' (A) Is substantially equivalent to marketed devices.

(B) Requires premarket approval. NOT substantially equivalent to marketed devices.

(D) Other (e.g., exempt by regulation, not a device, duplicate, etc.)

Additional Comments Chýýe w c t terse r . ýý4- w.s_. Ml t.- P4 j $ý Is this device subject to Postmarket Surveillance? Yes Q No

This 510(k) contains: (check appropriate box(es))

Q A 510(k) summary of safety and effectiveness, or

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:

No Confidentiality r

Confidentiality for 90 days Additional Product Code(s) ::;Panel (Uptional ): Continued Confidentiality exceeding 90 days

REVIEW:

FINAL REVIEWi (DIVISION DIRECTOR) (DATE) i "SE" *DOES NOT APPLY TO ANY DECISIONS Revised 11/18/91

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 EQUIVALENCE" 510(k) "SUBSTANTUL DEG'TSION-MAKING PROCESS (DETAILED)

Ncw DcvUx 14 Camp-" Mukc" f?crýoc' o Q A D° the Akor the tntcada4 I No Dtlfcrcooct yes Do," Ncw DErtoc Ravc Same ZlcrspoutlcJDtaeascttcldc. , cadiadoe St.tcma.ts! Effod (La Doddtae. May 'Not ýutýt.atlatly CoaAda' Impact GO Salcty and Equivalatt'v EffoWvascs<1?" I?ctumln.Voa yý

No satpdvc Wotmadoa New pevioe tat Saaae latctidod New Dertoc Has New rut Ncw or Marlcdod tkt and bc'Sold.adally tatatsod Ucc Mayt,.q.dval

Perform ancc Pcrfocmancc Dau Data Rcquitcd RcquItcd 11

L Pcriormancc Da4 Danows

No No

equiv.latr To 'sutuw,tt.ny Dccmtnatioa TO 0

' 510(k) submissions compare new devices to marketed devio= FDA requests additional information if tlLC relationship "predicate" betwr---n marketed and (pre-Amcodments or rcdasaicd post-Amutdmcns) devices is tutcicac:

" This decision is normally based on dcsaiptive infortnation alone, but limited testing ittlormadoft is sometttnes requited.

"' Data may be in the 510(k), other 510(k)s, the Center's classification files, of the lituaturc. _ _

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 EQUIVALENCE" j'ý-Records ( processed"SUBSTANTIAL under FOIA Request 2014-5115;(S$) DECISION Released MAKING 10/15/14 DOCUMENTATION

. REVIEWER: ý° r _ YDIVISION/BRANCH: V0jh-brr ! i -I I .4 LL TRADE NAME: ýý' .'f('r s COMMONNAME: :i

PRODUCT TO WHICH COMPARED: (510(k) NUMBER IF KNOWN)

YES (NO

- 1. IS PRODUCT A DEVICE? IF NO STOP

- 2. DEVICE SUBJECT TO 510(k)? IF NO STOP

-. - .. `J: SAME INDICATION STATEMENT? IF YES .GO TO r

DO DIFFERENCES ALTER THE EFFECT . OR RAISE -NEW.ISSUES OF. SAFETY OR _ . . - _ STOP.-' .EFFECTIVENESS? - _ .. , - . . . -. . -- . -.. . IF YES NE

' ' . .-. S . SAME .TECHNOLOGICAL CHARACTERISTICS? . .ý. . . - IF YES CO .TO 7 . _ v

.CoVLD THE NEW AFFECT' OR" CHARACTEUST-ICS_ -- . . ' SAFETY EFFECTIVEttEes? ..: . - IF YES =GO TO '8

CHARACTERISTICS PRECISE - IF NO GO. TO 7. DESCRIPTIVE a 10A ENOUGH? - IF YES STOP SýE

NEW TYPES OF SAFETY OR EFFECTIVENESS QUESTIONS? - IF YES STOP - NE

.9. ACCEPTED SCIENTIFIC METHODS EXIST? - IF NO STOP - NE

10. PERFORMANCE DATA AVAILABLE? - IF NO.REQUEST DAI

.11 DATA DEMONSTRATE EQUIVALENCE?. _ A E: "YES" O IN ADDITION TO, COMPLETING PAGE TW0. RESPONSES TO QUESTIONS 4.. 6, 8, AN "NO" 11. AND EVERY RESPONSE REQUIRES AN EXPLNNATION.ON PAGE.TEREE AND/OR FOU

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"SUBSTANTIAL EQUIVALENCE" (SE) DECISION-MAKING DOCUMENTATION

IN_ýAATIVE DEVICE DESCRIPTION

1.INTENDED USE: BioClinical Systems Chocolate Agar is an enriched medium for the isolation and cultivation of fastidious microorganisms such as Neisseria and Haemophilus species from various clinical specimens.

2.DEVICE DESCRIPTION: Provide a statement of how the device is either similar to and/or different from other marketed devices, plus data (if necessary) to support the statement. The following should be considered when preparing the summary of the statement. Is the device sterile? Is the device for single use? Is the device for home use or prescription use? Does the device contain drug or biological product as a component? Provide a summary about the devices design, materials, physical properties and toxicology profile if important.

SUMMARY: BioClinical Systems Chocolate Agar is similar to Becton Dickinson's Chocolate II Agar already in commercial distribution.

ith devices are for in vitro diagnostic use only, and use the same formula for making the Agar; selected meat peptone, corn starch, GC agar, Hemoglobin and an enrichment solution which has been demonstrated to provide a favorable environment for fastidious organisms.

Both devices use the same NCCLS recommended Quality Control organisms to assure that the commonly isolated organism will grow.

The medium is plated in petri dishes and is for single use. Medium is inoculated with patient specimen, streaked, and then incubated, usually in carbon dioxide rich atmosphere at 35-37°C for 18-24 hours.

BioClinical Systems Chocolate Agar is substantially equivalent to the predicate device.

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MEMO RECORD DATE: December 6, 1993 FROM: Freddie M. Poole OFFICE: ODE TO: File, K933121 DIVISION: DCLD/MI SUBJECT: BioClinical systems Chocolate Agar -Telecommunication

The manufacturer was asked to revise the labeling to remove all references of CLIA, add a limitation statement, and submit a statement or summary. Revisions requested to the labeling were not completed. The labeling still contained references for Assurance Testing for CLIA. Also, the p,i. recommended incubation of 33-37°C,

Will call the manufacturer to have them remove other CLIA references and address the different incubation temperature.

December 10, 1993

Ms, Powers called back and agreed to make the changes and resubmit the labeling.

January 5, 1994

Additional CLIA information was removed, but temperatures remained the same.

_- Called Ms. Babka to ask if they had overlooked the temperature change. - Ms. Babka replied that the reason they did not change was to accommodate the users,

Informed Ms. Babka that if all NCCLS standards and literature references recommend 35-37°C. If they wanted to leave it at 33°C they would have to submit data to verify that fastidious organisms such as Neisseria and Haemophilus could grow at 33°C.

- Ms. Powers stated that they will revise their labeling, they did not wish to do any studies.

February 3, 1994

All revisions were made. The device could be SE'd. However, after consulting with our Branch Chief and the 510k staff we determined that this device should have the intended use in the labeling.

REVIEWER'S SIGNATURE...... 0° ......

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Bio0inical A Systems Inc.

January 10, 1994

Food and Drug Administration Division of Clinical Laboratory Devices (HFZ-440) 1390 Piccard Drive Rockville, MD 20850

Re: 510(k) Notification Microbiological Culture Media #K933121/ #K933122

Attention: Ms. Freddie Poole

(b) (4)

PRODUCT CAT. NO. 510(k) No. ..~' Chocolate Agarý) 1020 K933121

Martin Lewis Agar 1095 K933122

If you have any further questions or require any additionalinformation, please contact me at (301) 498-9550.

Sincerely,

Kathry Babka Powers Regulatory Affairs

9040Questions?Junction Drive, Contact Suite FDA/CDRH/OCE/DIDOne " AnnapolisJunction, at [email protected] 20701, USA " (301)498-9550/FAX or 301-796-8118(301) 470-4129 Records processed under FOIA Request 2014-5115; Released 10/15/14

BioClinical Systems, Inc. Product No. 1020 800-638-2625 Revision No. 04 . PRODUCT INFORMATION AND QUALITY CONTROL SHEET CHOCOLATE AGAR

1. INTENDED USE Do not use plates that exhibit evidence of drying, cracking, Chocolate Agar is an enriched medium for the isolation and discoloration, microbial contamination or any other signs of cultivationoffastidious microorganisms,especiallyNeisseria deterioration. The presence of excessive condensate may and Haemophilus species from a variety of clinical indicate plates which have been damaged by exposure to specimens. temperature extremes.

II. SUMMARY AND EXPLANATION VII. SPECIMEN COLLECTION Bacto GC Medium Base was designed in 1947. Christensen The quality of culture results depends primarily on the and Schoenlein demonstrated that this base, enriched with adequacy and condition of the specimen submitted for hemoglobin and supplements yielded accelerated early examination. Proper specimen collection techniques gonorrhoeae.' must growth of Neisseria This medium was be followed to ensure the most accurate culture results. improved upon by substituting a chemical supplement for Sterile swabs and collection containers should be used. the yeast concentrate? In addition to aiding the growth of Plates should be inoculated promptly after specimen gonococci, other fastidious organisms, e.g. Haemophilus collection. If a delay in inoculation is unavoidable, transport species was also improved. medium should be employed. Specimens should be collected prior to the initiation of antimicrobial therapy. III.PRINCIPLES OF THE PROCEDURE Chocolate agar contains a GC agar base, bovine Detailed information on proper specimen collection may be hemoglobin, and a chemically defined enrichment. Casein obtained from microbiology reference materials 3.4.6 and meat peptones contained in the GC agar base provide the nitrogenous elements, phosphate buffers maintain the VIII. MATERIALS PROVIDED pH and corn starch neutralizes any toxic fatty acids that Chocolate Agar Plates and lot specific Quality Control may be present in the agar. Hemin (X factor) is provided by Certificate. the bovine hemoglobin, necessary for growth of Haemophilus species. The chemically defined enrichment IX. MATERIALS REQUIRED BUT NOT PROVIDED solution provides nicotinamide adenine dinucleotide/NAD (V Incubator maintaining 35 - 37°C. factor), vitamins, amino acids, co-enzymes, dextrose, ferric Ancillary culture media, reagents and laboratory equipment ions and other factors for improved growth of Nelsseria as required. species. X. PROCEDURE V. TYPICAL FORMULA AND APPEARANCE Inoculate the specimen as soon as possible after it is = Appearance opaque, chocolate brown received in the laboratory. The streak plate method is used (Approximate formula' per liter of processed water) primarily to isolate pure cultures from specimens containing Pancreatic Digest of Casein 7.5g mixed! flora. If material is being cultured directly from a Selected Meat Peptone 5.0 swab, roll the swab over a small area of the plate surface at Corn Starch 1.0 the edge (approximately 114 to 113 of the plate); then Dipotassium phosphate 4.0 streak in a zig-zag fashion with a sterile loop from this Monopotassium phosphate 1.0 inoculated area in two sections to cover the entire agar Sodium Chloride 5.0 surface; flaming or flipping loop between sections. Avoid Agar 12.0 applying excessive pressure to the agar surface during Hemoglobin 10.0 inoculation to prevent gouging and splitting of the agar Chocolate enrichment solution 10 ml media. (Note: Agar surfaces should be smooth and moist 'adjusted and/or supplemented to meet performance but free of excessive moisture which could cause confluent criteria. growth patterns.)

V. PRECAUTIONS Since many fastidious microorganisms require carbon This product is for IN VITRO diagnostic use only. Culture dioxide on primary isolation, plates should bb incubated in specimens contain microorganisms which may can be an atmosphere of approximately 3-1096 COz (atmospheric potentially infectious to the user. Strict adherence to incubator or zip-lock bag with generator). Incubate plates aseptic techniques and established precautions against media side up at 35-37°C for 18-24 hours. microbiological hazards should be followed throughout the procedure. Carefully dispose of all items which contact XI. EXPECTED RESULTS patient specimens or isolated bacteria. (See Material Safety Data Sheet for further information.) NCCLS CONTROL ORGANISMS (ATCC STRAINS) Neisseria gonorrhoeae Growth VI. STORAGEISHEIF LIFE (ATCC 43069) Plated media should be stored at 2-8°C (36-46°F), media side up, in the unopened or resealed package protected Haemophilus influenzae Growth from light. DO NOT FREEZE OR EXPOSE TO HIGH (ATCC 10211) TEMPERATURES. Allow unopened plates to warm to room temperature prior to inoculation. Prior to and Streptococcus pneumaniae Growth during (ATCC inoculation procedures, plates should be handled in a 6305) manner that minimizes product exposure to the Neisseria meningitidis Growth environment. Product which has exceeded the assigned (ATCC 13090) expiration date noted on the label should not be used.

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XII. LABORATORY RESULTS Inspect plates according to instructions contained to be used as a isolation on the BioClinical Systems, Inc. "Quality Control This medium is intended primary Sheet." medium. Presumptive identification of organisms may be Log (See also Section VI "STORAGE/ made on the basis of typical organism morphology and SHELF LIFE") Gram stain. Definitive identification of certain organisms product label and antimicrobial sensitivity determination requires further 2. Peet off the lower portion of a bag Control for the lot testing with supplementary materials. Additional (BCS Quality Certificate) being biochemical information may be obtained from reference accepted into the laboratory and affix it to the .1.4.6 Control Sheet. microbiology texts Quality Log

)all. LIMITATIONS Initial and date the Quality Control Log Sheet. The ability to detect microorganisms by culture techniques if media does can be affected by the following factors: improper specimen Note: Notify Technical Service immediately collection, storage and inoculation, initiation of antiinfective not meet the inspection criteria. therapy prior to specimen collection, improper culture incubation temperatures and atmospheres, improper length This media is not exempt from end user quality control of culture incubation, and improper storage and handling of testing relating to media growth characteristics according to culture media. NCCLS Document M22A, Quality Assurance for Commercially Prepared Microbiological Culture Media. Chocolate agar is an enriched medium. Pathogenic Quality Control organisms may be ordered by contacting our organisms may be overgrown by nonpathogenic or normal customer service department. specimen flora.

XIV. REFERENCES TECHNICAL SERVICE 1. Difco Manual, Dehydrated Culture Media and Reagents for Microbiology, 10th ®d. 1984. Difco Laboratories, BioClinical Systems provides a tall free technical service line Detroit, MI. (1-800-638-2625) to assist with product usage. To receive additional product information, procedural instructions, 2. Power, D.A. (ad.) and P.J. McCuen. 1988. Manual of QA/QC log sheets, Material Safety Data Sheets, or to have BBL products and laboratory procedures, 6th ad. Becton technical questions answered; please call between the Dickinson Microbiology Systems, Cockeysvil(e, MD. hours of 9:00 am to 5:00 pm EST.

3. Fnegold, S.M. and W.S. Martin. 1982. Bailey and BioCfinical.Systems, Inc. Scott's Diagnostic Microbiology, 6th ad. C.V. Mosby 9040 Junction Drive, Suite 1 Company, St, Louis. Annapolis Junction, MD 20701

4. Koneman, E.S., S.D.Allen, V.R. Dowell, Jr. and H. M. 1-800-638-2625 Sommers. 1983. Color Atlas and Textbook of Microbiology, 2nd ad. J.B. Lippincot Company, January, 1994 Philadelphia.

5. Lennette, E.H., ad. 1985. Manual of Clinical Microbiology, 4th ad. American Society for Microbiology, Washington, D.C.

USER QUALITY ASSURANCE/ QUALITY CONTROL PROCEDURES AND INFORMATION

BioClinical Systems recommends that the following quality assurance and quality control procedures be performed on each batch of product.

1. QUALITY ASSURANCE . The following quality assurance procedures must be performed to assure the product will perform according to its intended use within the assigned expiry date:

1. Daily, document that product storage refrigerator maintains temperature within the recommended range: 2-80C.

2. Daily, document that laboratory incubator temperature within the recommended main-tains range: 33-37°C.

II. QUALITY CONTROL The following incoming inspection procedures must be performed for each batch (batch = same lot. same Product No. 1020 Rev. No. 04 shipment) of culture media received in the laboratory

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BioClinical Systems Inc.

December 20, 1993

Food and Drug Administration Division of Clinical Laboratory Devices (HFZ-440) 1390 Piccard Drive Rockville, MD 20850

Re: 510(k) Notification Microbiological Culture Media #K9331211 #K933122

Attention: Ms. Freddie Poole

As per your request, the following product information sheets have been revised to reflect the removal of a reference to the Clinical Laboratory Improvement Act (CLIA) through the offer of CLIA manuals as listed under "TECHNICAL SERVICE".

PRODUCT CAT. NO. No. a._ 510(k) (ý Chocolate Agar--) 1020 K933121

Martin Lewis Agar 1095 K933122

If you have any further questions or require any additional information, please contact me at (301) 498-9550.

Sincerely, t

Kathy Babka Powers Regulatory Affairs

9040Questions?Junction Drive, ContactSuite FDA/CDRH/OCE/DID One 0 AnnapolisJunction, at [email protected] 20701,USA " (301)498-9550/FAX or 301-796-8118(301) 470-4129 Records processed under FOIA Request 2014-5115; Released 10/15/14 BioClinical Systems, Inc. Product No. 1020 800-638-2625 Revision No. 03 PRODUCT INFORMATION AND QUALITY CONTROL SHEET CHOCOLATE AGAR

1. INTENDED USE Do not use plates that exhibit evidence of drying, cracking, Chocolate Agar is an enriched medium for the isolation and discoloration, microbial contamination or any other signs of cultivation offastidiousmicroorganisms, especiall yNeisseria deterioration. The presence of excessive condensate may and Haernophilus species from a variety of clinical indicate plates which have been damaged by exposure to specimens. temperature extremes.

11.SUMMARY AND EXPLANATION VII. SPECIMEN COLLECTION Bacto GC Medium Base was designed in 1947. Christensen The quality of culture results depends primarily on the and Schoenle)n demonstrated that this base, enriched with adequacy and condition of the specimen submitted for hemoglobin and supplements yielded accelerated early examination. Proper specimen collection techniques must growth of Nelsseria gonorrhoeae.' This medium was be followed to ensure the most accurate culture results. containers should be used. improved upon by substituting a chemical supplement for Sterile swabs and collection the yeast concentrate.' In addition to aiding the growth of Plates should be inoculated promptly after specimen gonococci, other fastidious organisms, e.g. Haernophilus collection. If a delay in inoculation is unavoidable, transport species was also improved. medium should be employed. Specimens should be collected prior to the initiation of antimicrobial therapy. Ill. PRINCIPLES OF THE PROCEDURE Chocolate agar. contains a GC agar base, bovine Detailed information on proper specimen collection may be materials 3.4.5 hemoglobin, and a chemically defined enrichment. Casein obtained from microbiology reference and meat peptones contained in the GC agar base provide the nitrogenous elements, phosphate buffers maintain the Vlll. MATERIALS PROVIDED pH and corn starch neutralizes any toxic fatty acids that Chocolate Agar Plates and lot specific Quality Control may be present in the agar. Hemin (X factor) is provided by Certificate. the bovine hemoglobin, necessary for growth of Haemophilus species. The chemically defined enrichment IX. MATERIALS REQUIRED BUT NOT PROVIDED solution provides nicotinamide adenine dinucleotideJNAD (V Incubator maintaining 33-37°C. factor), vitamins, amino acids, co-enzymes, dextrose, ferric Ancillary culture media, reagents and laboratory equipment ions and other factors for improved growth of Neisseria as required. species. X. PROCEDURE V. TYPICAL FORMULA AND APPEARANCE Inoculate the specimen as soon as possible after it is Appearance = opaque, chocolate brown received in the laboratory. The streak plate method is used (Approximate formula* per liter of processed water) primarily to isolate pure cultures from specimens containing Pancreatic Digest of Casein 7.5g mixed flora. If material is being cultured directly from a Selected Meat Peptone 5.0 swab, roll the swab aver a small area of the plate surface at Corn Starch 1.0 the edge (approximately 114 to 1/3 of the plate); then Dipotassium phosphate 4.0 streak in a zig-zag fashion with a sterile loop from this Monopotassium phosphate 1.0 inoculated area in two sections to cover the entire agar Sodium Chloride 5.0 surface; flaming or flipping loop between sections. Avoid Agar 12.0 applying excessive pressure to the agar surface during Hemoglobin 10.0 inoculation to prevent gouging and splitting of the agar Chocolate enrichment solution 10 ml media. (Note: Agar surfaces should be smooth and moist *adjusted and/or supplemented to meet performance but free of excessive moisture which could cause confluent criteria. growth patterns.)

V. PRECAUTIONS Since many fastidious microorganisms require carbon This product is for IN VITRO diagnostic use only. Culture dioxide on primary isolation, plates should be incubated in specimens may contain microorganisms which can be an atmosphere of approximately 3-10% COz (atmospheric potentially infectious to the user. Strict adherence to incubator or zip-lock bag with generator). Incubate plates aseptic techniques and established precautions against media side up at 33-37°C for 18-24 hours. microbiological hazards should be followed throughout the procedure. Carefully dispose of all items which contact XI. EXPECTED RESULTS (See Material patient specimens or isolated bacteria. Safety NCCLS CONTROL ORGANISMS (ATCC STRAINS) Data Sheet for further information.) Neisseria gonorrhoeae Growth VI. STORAGE/SHELF LIFE (ATCC 43069) Plated media should be stored at 2-8°C (36-46°F), media side up, in the unopened or resealed package protected Haemaphilus influenzae Growth from light. DO NOT FREEZE OR EXPOSE TO HIGH (ATCC 10211) TEMPERATURES. Allow unopened plates to warm to room Streptococcus pneumoniae Growth temperature prior to inoculation. Prior to and during (ATCC 6305) inoculation procedures, plates should be handled in a manner that minimizes product exposure to the Neisseria meningitidis Growth environment. Product which has exceeded the assigned (ATCC 13090) expiration date noted on the label should not be used.

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 I!J Records processed under FOIA Request 2014-5115; Released 10/15/14

XII. LABORATORY RESULTS 1. Inspect plates according to instructions contained This medium is intended to be used as a primary isolation on the BioClinical Systems, Inc. Sheet." "Quality Control medium. Presumptive identification of organisms may be Log (See also Section VI "STORAGE/ made on the basis of typical organism morphology and SHELF LIFE") Gram stain. Definitive identification of certain organisms and antimicrobial sensitivity determination requires further 2. Peel off the lower portion of a product bag label testing with supplementary materials. Addition (BCS Quality Control Certificate) for the lot being biochemical information may be obtained from reference accepted into the and affix it to the 3.4,s laboratory microbiology texts Quality Control Log Sheet.

XIII. LIMITATIONS 3. Initial and date the Quality Control Log Sheet. The ability to detect microorganisms by culture techniques can be affected by the following factors: improper specimen Note: Notify Technical Service immediately if media does collection, storage and inoculation, initiation of antiinfective not meet the inspection criteria. therapy prior to specimen collection, improper culture incubation temperatures and atmospheres, improperlength This media is not exempt from end user quality control of culture incubation, and improper storage and handling of testing relating to media growth characteristics according to culture media. NCCLS Document M22A, Quality Assurance far Commercially Prepared Microbiological Culture Media. Chocolate agar is an enriched medium. Pathogenic Quality Control organisms maybe ordered by contacting our organisms may be overgrown by nonpathogenic or normal customer service department. specimen flora.

XIV. REFERENCES TECHNICAL SERVICE 1. Difco Manual, Dehydrated Culture Media and Reagents for Microbiology, 10th ad. 1984. Difco Laboratories, BioClinical Systems provides a toll free technical service line Detroit, MI. (1-800-638-2625) to assist with product usage. To receive additional product information, procedural instructions, 2. Power, D.A. (ad.) and P.J. McCuen. 1988. Manual of QA/QC log sheets, Material Safety Data Sheets, or to have 6th Becton BBL products and laboratory procedures, ad. technical questions answered; please call between the Dickinson Microbiology Systems, Cockeysville, MD. hours of 9:00 am to 5:00 pm EST.

3. Finegold, S.M. and W.S. Martin. 1982. Bailey and BioClinical Systems, Inc. Scott's Diagnostic Microbiology, 6th ad. C.V. Mosby 9040 Junction Drive, Suite 1 Company, St, Louis. Annapolis Junction, MD 20701

4. Koneman, E.S., S.D.Allen, V.R. Doweli, Jr. and H. M. 1-800-638-2625 Sommers. 1983. Color Atlas and Textbook of 2nd ad. J.B. Lippincot Microbiology, Company, December, 1993 Philadelphia.

5. Lennette, E.H., ad. 1985. Manual of Clinical Microbiology, 4th ed. American Society for Microbiology, Washington, D.C.

USER QUALITY ASSURANCE! QUALITY CONTROL PROCEDURES AND INFORMATION

BioClinical Systems recommends that the following quality assurance and quality control procedures be performed on each batch of product.

1. QUALITY ASSURANCE The following quality assurance procedures must be performed to assure the product will perform according to its intended use within the assigned expiry date:

1. Daily, document that product storage refrigerator maintains temperature within the recommended range: 2-8°C.

Daily, document that laboratory incubator temperature within the recommended main-tains range: 33-37°C.

11. QUALITY CONTROL The following incoming inspection procedures must be performed for each batch (batch = same same lot, Product No. 1020 Rev. No. 03 shipment) of culture media received in the laboratory

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

DEPARTMENTOF HEALTHAND HUMANSERVICES Public Health Service

Food and Drug Administration Center for Devices and Radiological Health office of Device Evaluation Document Mail Center (HF8-901) 1390 Piccard Drive Rockville, Maryland 20850

September 03, 1993

BIOCLINICAL SYSTEMS, INC. 510(k) Number: K933121 9040 JUNCTION DR. Product: MICROBIOLOGICAL SUITE ONE CULTURE 20701------ANNAPOLIS JUNCTION, MD MEDIA,CHOCOLATE ATTN: KATHRYN POWERS AGAR

The additional information you have submitted has been received.

We will notify you when the processing of this submission has been completed or if any additional information is required. Please remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent to any address other than the one above will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitations we cannot accept telefaxed material as part of your official premarket notification submission, unless specifically requested of you by an FDA official.

The Safe Medical Devices Act of 1990, signed on November 28, states that you may not place this device into commercial distribution until 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 90 days. However, the complexity of a submission or a requirement for additional information may occasionally cause 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.

If you have procedural or policy questions, please contact the Division of Small Manufacturers Assistance at (301) 443-6597 or at their toll-free number (800) 638-2041, or contact me at (301) 594-1190.

Sincerely yours,

Marjorie Shulman Supervisory Consumer Safety Officer Premarket Notification Section Office of Device Evaluation Center for Devices and Radiological Health

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; ReleasedK 10/15/14 t 4t331Z,ps BioClinical Systems Inc.

August 24, 1993

Food and Drug Administration Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, MD 20850

Re: 510(k) Notification Microbiological Culture Media '.' #K933121

Attention: Document Control Clerk

The attached information is provided at the request of the Office of Device Evaluation for 510(k) submission #K933121 currently in progress. If any additional information is required for routing purposes, please contact me, (301) 498-9550.

Sincerely,

KathrBabka Powers Regulatory Affairs

9040Junction Suite One " Annapolis MD USA " Questions?Drive, Contact FDA/CDRH/OCE/DIDJunction, at [email protected] 20701, (301)498-9550/FAX or 301-796-8118(301) 470-4129 E.

Records processed under FOIA Request 2014-5115; Released 10/15/14

BioClirical /000Systems Inc.

TO: Office of Device Evaluation

RE: #K933121

DATE: 8124/93

FROM: Kathryn Babka Powers

The following information is provided at your request to resolve questions and document additional data required for 510(k) submission #K933121. C" 1. Modified "Attachment - Safety and Effectiveness/Substantial Equivalence Systems' BioClinical Safety and Effectiveness statement, designed to satisfy the SMDA of 1990, has been modified to conform to model language guidelines and appears in a one page signed format on company letterhead. Substantial equivalence data and statements have been typeset to appear on a separate page.

2. Modification of Product Information Sheet

Revision 01 of Product InformationSheet No. 1020 is attached. This has been modified to; 1) Revise the paragraph relating to CLIA information under the section "USER QUALITY ASSURANCE/QUALITY CONTROL PROCEDURES AND INFORMATION" and 2) additional statements under the "LIMITATIONS" Clarify testing section in reference to antibiotic susceptibility testing.

9040Junction Drive, Suite One " Annapolis MD USA 0 498-9550/FAX Questions? Contact FDA/CDRH/OCE/DIDJunction, at [email protected] 20701, (301) or 301-796-8118(301)470-4129 Records processed under FOIA Request 2014-5115; Released 10/15/14

ATTACHMENT A

DEVICE SAMPLE LABELING

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

BioClinical Systems, Inc. Product No. 1020 800-638-2625 Revision No. 01 PRODUCT INFORMATION AND QUALITY CONTROL SHEET CHOCOLATE AGAR

I. INTENDED USE Do not use plates that exhibit evidence of drying, cracking, Chocolate Agar is an enriched medium for the isolation and discoloration, microbial contamination or any other signs of cultivation of fastidious microorganisms, especiallyNeisseria deterioration. The presence of excessive condensate may and Haemophilus species from a variety of clinical indicate plates which have been damaged by exposure to specimens. temperature extremes.

II. SUMMARY AND EXPLANATION VII. SPECIMEN COLLECTION Bacto GC Medium Base was designed in 1947. Christensen The quality of culture results depends primarily on the and Schoenlein demonstrated that this base, enriched with adequacy and condition of the specimen submitted for hemoglobin and supplements yielded accelerated early examination. Proper specimen collection techniques must gonorrhoeae.' growth of Neisseria This medium was be followed to ensure the most accurate culture results. improved upon by substituting a chemical supplement for Sterile swabs and collection containers should be used. concentrate.' the yeast In addition to aiding the growth of Plates should be inoculated promptly after specimen gonococci, other fastidious organisms, e.g. Haernophilus collection. If a delay in inoculation is unavoidable, transport species was also improved. medium should be employed. Specimens should be collected prior to the initiation of antimicrobial therapy. III. PRINCIPLESOF THE PROCEDURE Chocolate agar contains a GC agar base, bovine Detailed information on proper specimen collection may be 3." hemoglobin, and a chemically defined enrichment. Casein obtained from microbiology reference materials and meat peptones contained in the GC agar base provide the nitrogenous elements, phosphate buffers maintain the VIII. MATERIALS PROVIDED pH and corn starch neutralizes any toxic fatty acids that Chocolate Agar Plates and lot specific Quality Control may be present in the agar. Hemin (X factor) is provided by Certificate. the bovine hemoglobin, necessary for growth of Haemophilus species. The chemically defined enrichment IX. MATERIALS REQUIREDBUT NOT PROVIDED solution provides nicotinamide adenine dinucleotidelNAD (V Incubator maintaining 33-37°C. factor), vitamins, amino acids, co-enzymes, dextrose, ferric Ancillary culture media, reagents and laboratory equipment ions and other factors for improved growth of Neisseria as required. species. X. PROCEDURE V. TYPICAL FORMULA AND APPEARANCE Inoculate the specimen as soon as possible after it is Appearance = opaque, chocolate brown received in the laboratory. The streak plate method is used (Approximate formula* per liter of processed water) primarilyto isolate pure cultures from specimens containing Pancreatic Digest of Casein 7.5g mixed flora. If material is being cultured directly from a Selected Meat Peptone 5.0 swab, roll the swab over a small area of the plate surface at Corn Starch 1.0 the edge (approximately 114 to 113 of the plate); then Dipotassium phosphate 4.0 streak in a zig-zag fashion with a sterile loop from this Monopotassium phosphate 1.0 inoculated area in two sections to cover the entire agar Sodium Chloride 5.0 surface; flaming or flipping loop between sections. Avoid Agar 12.0 applying excessive pressure to the agar surface during Hemoglobin 10.0 inoculation to prevent gouging and splitting of the agar Chocolate enrichment solution 10 ml media. (Note: Agar surfaces should be smooth and moist *adjusted and/or supplemented to meet performance but free of excessive moisture which could cause confluent criteria. growth patterns.)

V. PRECAUTIONS Since many fastidious microorganisms require carbon This product is for IN VITRO diagnostic use only. Culture dioxide on primary isolation, plates should be incubated in specimens may contain microorganisms which can be an atmosphere of approximately 3-10% COZ (atmospheric potentially infectious to the user. Strict adherence to incubator or zip-lock bag with generator). Incubate plates aseptic techniques and established precautions against media side up at 33-37°C for 18-24 hours. microbiological hazards should be followed throughout the procedure. Carefully dispose of all items which contact XI. EXPECTED RESULTS patient specimens or isolated bacteria. (See Material Safety NCCLS CONTROL ORGANISMS (ATCC Data Sheet for further information.) STRAINS) Nelsseria gonorrhoeae Growth VI. STORAGE/SHELF LIFE (ATCC 43069) Plated media should be stored at 2-8°C (36-46°F), media side up,. in the unopened or resealed package protected Haemophilus influenzae Growth from light. DO NOT FREEZE OR EXPOSE TO HIGH (ATCC 10211) TEMPERATURES. Allow unopened plates to warm to room temperature prior to inoculation. Prior to and Streptococcus pneumoniae Growth during (ATCC inoculation procedures, plates should be handled in a 6305) manner that minimizes product exposure to the Neisseria meningiddis Growth environment. Product which has exceeded the assigned (ATCC 13090) expiration date noted on the label should not be used. Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

X11.LABORATORY RESULTS II. QUALITY CONTROL This medium is intended to be used as a primary isolation The following incoming inspection procedures must be medium. Presumptive identification of organisms may be performed for each batch (batch = same lot, same made on the basis of typical organism morphology and shipment) of culture media received in the laboratory Gram stain. Definitive identification of certain organisms and antimicrobial sensitivity determination requires further 1. Inspect plates according to instructions contained with materials. Additional on the BioClinical Systems, Inc. "Quality Control testing supplementary Sheet." biochemical information may be obtained from reference Log (See also Section VI "STORAGE! texts.',',' microbiology SHELF LIFE")

XIII. LIMITATIONS 2. Peel off the lower portion of a product bag label The ability to detect microorganisms by culture techniques (BCS Quality Control Certificate) for the lot being can be affected by the following factors: improper specimen accepted into the laboratory and affix it to the collection, storage and inoculation, initiation of antiinfective Quality Control Log Sheet. therapy prior to specimen collection, improper culture incubation temperatures and atmospheres, improperlength Initial and date the Quality Control Log Sheet. of culture incubation, and improper storage and handling of culture media. Note: Notify Technical Service immediately if media does not meet the inspection criteria. Chocolate agar is an enriched medium. Pathogenic organisms may be overgrown by nonpathogenic or normal This media is not exempt from end user quality control specimen flora. testing relating to media growth characteristics according to NCCLS Document M22A, Quality Assurance for XIV. REFERENCES Commercially Prepared Microbiological Culture Media. 1. Difco Manual, Dehydrated Culture Media and Reagents Quality Control organisms may be ordered bycontacting our for Microbiology, 10th ad. 1984. Difco Laboratories, customer service department. Detroit, MI.

2. Power, D.A. (ad.) and P.J. McCuen. 1988. Manual of TECHNICAL SERVICE BBL products and laboratory procedures, 6th ad. Becton " Dickinson Microbiology Systems, Cockeysville, MD. BioClinical Systems provides a toll free technical service line (1-800-638-2625) to assist with product usage. To receive 3. Finegold, S.M. and W.S. Martin. 1982. Bailey and additional productinformation, procedural instructions, CLIA Scott's Diagnostic 6th ad. C.V. Microbiology, Mosby manuals, QA/QC log sheets, Material Safety Data Sheets, Company, St, Louis. or to have technical questions answered; please call between the hours of 9:00 am to 5:00 pm EST. 4. Koneman, E.S., S.D.Allen, V.R. Dowel!, Jr. and H. M. Sommers. 1983. Color Atlas and Textbook of BioClinical Systems, Inc. Microbiology, 2nd ad. J.B. Lippincot Company, 9040 Junction Drive, Suite 1 Philadelphia. Annapolis Junction, MD 20701

5. Lennette, E.H., ad. 1985. Manual of Clinical 1-800-638-2625 Microbiology, 4th ad. American Society for Microbiology, D.C. Washington, August, 1993

USER QUALITY ASSURANCE/ QUALITY CONTROL PROCEDURES AND INFORMATION

BioClinical Systems recommends that the following quality assurance and quality control procedures be performed on each batch of product. For general information pertaining to CLIA and its requirements for your laboratory, see the Federal Register/ Vol. 57, No. 401 Friday, February 28, 1992 and subsequent published updates and revisions or call BioClinical Systems' Technical Service Department.

I. QUALITY ASSURANCE The following quality assurance procedures must be performed to assure the product will perform according to its intended use within the assigned expiry date:

Daily, document that product storage refrigerator maintains temperature within the recommended range: 2-8°C.

Daily, document that laboratory incubator temperature within the recommended main-tains range: 33-37°C.

Product No. 1020 Rev. No. 01

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

ATTACHMENT C

SAFETY AND EFFECTIVENESS STATEMENT

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 -ýo Records processed under FOIA Request 2014-5115; Released 10/15/14

MoClinical / 000Systems Inc.

Device: Chocolate Agar

"This statement and effectiveness is regarding safety 1990."being submitted in accordance with the requirements of SMDA

"I certify that Kathryn Babka Powers will make available all informationrespecting safety and effectiveness that supports finding of substantial equivalence included in this premarket notification within 30 days of request by any person. The information I agree to make available does not include confidential patient data or information." confidential or trade secret manufacturingprocess

'1 -2 Kath yn abl Powers Regulat ry Affairs

9040Junction Drive, Suite One " AnnapolisJunction, MD 20701,USA " (301)498-9550/FAX (301) 470-4129 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

ATTACHMIENT D

SUBSTANTIAL EQUIVALENCE DATA

I-)-ý,

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

ATTACHMENT D

DEVICE: CHOCOLATE AGAR

1.0 Substantial Equivalence Data

4- 1.1 Samples of BioClinical Systems (BCS) Chocolate Agar were tested in parallel with Becton Dickinson Microbiology Systems (BDMS) Chocolate Agar according to the recommended quality control procedures established by the National Committee for Clinical Laboratory Testing (NCCLS) guideline document M22-A, "Quality Assurance for Commercially Prepared Microbiological Culture Media.

1.2 The following laboratory data outlined in Table 1 establishes the substantial equivalence of these products.

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

DEPARTMENTof HEALTH ArmHUMAN SERVICES Public Health Service

Food and Drug Administration Center for Devices and Radiological Health office of Device Evaluation Document Mail Center (HFS-401) 1390 Piccard Drive Rockville, Maryland 20850

August 18, 1993

BIOCLINICAL SYSTEMS, INC. 510(k) Number: K933121 9040 JUNCTION DR. Product: MICROBIOLOGICAL SUITE ONE CULTURE ANNAPOLIS JUNCTION, MD 20701 MEDIA,CHOCOLATE ATTN: KATHRYN POWERS AGAR

We are holding your above-referenced Premarket Notification (510(k)) for 30 days pending receipt of the additional information that was requested by the office of Device Evaluation. Please remember that all correspondence concerning your submission MUST be sent in duplicate to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent to any address other than the one above will not be considered as part of your official premarket notification submission. Because of equipment and personnel limitations, we cannot accept telefax material as part of your official premarket notification submission unless specifically requested of you by an FDA official. "m If after 30 days the requested information is not received, we will discontinue review of your submission and proceed to delete your file from our review system. Pursuant to 21 CFR 20.29, a copy of your 510(k) submission will remain in the office of Device Evaluation. If you then wish to resubmit this 510(k) notification, a new number will be assigned and your submission will be considered a new premarket notification submission.

Please remember that the Safe Medical Devices Act of 1990 states that you may not place this device into commercial distribution until you receive a decision letter from FDA allowing you to do so.

Sincerely yours,

Marjorie Shulman Supervisor Consumer Safety Officer Premarket Notification Section Office of Device Evaluation Center for Devices and Radiological Health

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

510(x) ROUTE SLIP

510(k) NUMBER K933121 PANEL MI DIVISION DCLD BRANCH

TRADE NAME MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

COMMON NAME

PRODUCT CODE

MANUFACTURER BIOCLINICAL SYSTEMS, INC. REGISTRATION N0. 1120183

DATE ON SUBMISSION 25-JUN-93 DATE DUE TO 510(K) STAFF

ATE RECEIVED IN ODE 25-JUN-93 DATE DECISION DUE 23-SEP-93

DECISION DECISION DATE

SUPPLEMENTS RECEIVED DUE OUT DUE BACK

C001 18-AUG-93 17-SE ADD TO FILE

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 ýJýýaSEýICFS,GS1 DEPARTMENT OF HEALTH 8t HUMAN SERVICES Public Health Service Memorandum

rte 'ýý l týF3

_From REVIEWER(S) - NAME(S)ýrý 04

Subject 510(k) NOTIFICATION V) 'q S 5 1 ?-ý I

To THE RECORD

It is my recommendation that the subject 510(k) Notification:

(A) Is substantially equivalent to marketed devices.

(B) Requires premarket approval. NOT substantially equivalent to marketed devices.

ý(C) Requires more data. ýý r Atwý- ,

(D) Other (e.g., exempt by regulation, not a device, duplicate, etc.)

Additional Comments:

Is this device subject to Postmarket Surveillance? Yes a No a This 510(k) contains: (check appropriate box(es))

A 510(k) summary of safety and effectiveness, or

A 510(k) statement that safety and effectiveness information will be made available E 11 The required certification and summary for class III devices

The submitter requests under Predicate Product Code w/panel 21 CFR 807.95:* and class:

No Confidentiality

Confidentiality for 90 days Additional Product Code(s) w/Panel (optional): Continued Confidentiality exceeding 90 days

REVIEW: (BRANCH CHIEF) BRANCH CODE (DATE)

FINAL REVIEW: (DIVISION DIRECTOR) (DATE)

*DOES NOT APPLY TO ANY "SE" DECISIONS Revised 11/18/91 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

EQUIVALENCE" 510(k) "SUBSTANTIAL DECISION-MAKING PROCESS (DETAILED)

New Device Is Compared to Dcvke* Marketed o A D° the ý Alter the Intended 01 NO Differ Yes Does New Device Have Same tlerapeuOdDLaidde. Indication Statements? Effect (in Deciding, May "Not Substantially Equivalent" Consider Impact on Safety and Yes Effealvenesc Determination

No ' Descriptive information New Devtex Has Same Intended New Device Has New abort New or Marketed Use and May be -5u6staatialty intended Use Device Requested as Needed

New Could the New Do the New Characteristics Don Device Have Same NO Yes Y.S 1'echaologkd Charade, _ _ Characteristics -ý New Types of Safety or Questions?** Design. Materials, etc:? Affect Safety Effectiveness -c.g., or Effectiveness? Yes No No 0 1 @ I Arc the Descriptive Do Accepted Scientific Methods No arack r l s !tesp r eci se ghFaoa Etdsi for AssessingEffects of to Ea5UrG EqtdvaldlOG? the New ChamdtriSfiCS? No Yes Yes 10 10 No Are Performance Data Avail" Are Performance Data Available NO to Assess Equivalence?"` to Assess Effects of New Characteristics? " ". Yes Yes

Performance Performance Data Data Required Required 11

L Performance Data V -" ---.0 ---Q Performance Data Demonstrate Equivaknce?DemaastrateY Yes Equivalence? INo No Equivalent" "Substantially TO To Determination G

510(k) submissions compare new devices to marketed devices. FDA requests additional information if thp relationship "predicate" between marketed and (pre-Amendments or reclassified post-Amendments) devices is ut4eai.

This decision is normally based on descriptive information alone, but limited testing inforenatioft is sometimes required. "`' Data maybe in the 510(k), other 510(k)s,the Center's classificationfiles, or the literature.

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

MEMO RECORD DATE: August 13, 1993 __ FROM: Freddie M. Poole OFFICE: ODE T0: File, K933121 DIVISION: DCLD/MI SUBJECT: BioClinical Systems, Inc. Chocolate Media

BioClinical systems submitted this Chocolate culture media for the isolation and cultivation of pathogenic Neisseria .

The manufacturer performed a comparison study in which NCCLS suggested control organisms were grown under C02 for 18-24hrs and the results compared to BDMS Chocolate Agar. However the manufacturer did not state how the media was prepared.

The labeling contains wording that is unclear and did not specify that susceptibility testing was not to be done using this media. The labeling also includes language for CLIA.

The SMDA Summary or Statement was not submitted.

Approval to Call Manufacturer: Sharon L. Hansen, P .D. Branch Chief

August 18, 1993

Conversation with: Kathryn B. Powers Regulatory Affairs BioClinical Systems

Informed Ms. Powers of the above concerns.

Ms. Powers responded that BioClinical did not make their own media. The media was obtained in dehydrated form from another manufacturer. They tested it upon receipt following criteria in NCCLS document M22-A.

Ms. Powers agreed to remove wording on susceptibility testing from the Laboratory Results section and make it a Limitation statement. It will now read that this media is not to be used for antimicrobial susceptibility testing. All CLIA language will be removed and placed in a technical bulletin informing user that FDA has not yet implemented certification for CLIA.

Ms. Powers will also check with management on whether to submit a statement or summary.

SIGNATURE.. ".,. ...... PAGE NO...1 .`:ý,.....

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IPARTHENT 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

JULY 8, 1993

BIOCLINICAL SYSTEMS, INC. 510(k) Number: K933121 ATTN: KATHRYN POWERS Received: 06-25-93 9040 JUNCTION DR. Product: MICROBIOLOGICAL SUITE ONE CULTURE ANNAPOLIS JUNCTION, MD 20701 MEDIA,CHOCOLATE AGAR

The Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE), has received the Premarket Notification you 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 correspondence that relates to this submission. We will notify you when the processing of your premarket notification has ien completed or if any additional information is required.

-in regard to FDA's role in implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which became effective on September 1, 1992, FDA has not yet been fully funded to perform CLIA Quality Control (QC) validation assessments and complexity categorization. In the preamble to the CLIA regulation, it was made clear that FDA would not begin these activities until the agency had received the resources and personnel needed to perform the additional work involved. Accordingly, we will perform the 510(k) review requested. However, we will not perform a CLIA QC validation assessment or complexity categorization for your submission referenced above. FDA will announce the date upon which the agency will begin accepting requests for categorizations of previously cleared devices; will begin performing complexity categorizations along with premarket submission review; and will begin accepting submissions for CLIA QC validation assessment, by and not before the effective date of the notice in the Federal Register.

The Safe Medical Devices Act of 1990 (SMDA), signed on November 28, states that you may not place this device into commercial distribution until you receive a letter from FDA allowing you to do so. Although the traditional timeframes for reviewing 510(k)s has been 90 days, it is now taking longer. These increasing response times have been caused by many factors, including a sharp increase in ODE's workload and increasingly complex device submissions. During 1992, we received about 1,500 more total submissions than we did the preceding year. We are troubled by these increases in response times and are making every effort to regain predictability in the timing of 510(k) reviews. Due to the increase in response times, CDRH has established a 510(k) Status forting System through which submitters may receive a status report on their J(k) submissions(s) as follows:

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o Beginning 90 days after ODE receives your 510(k) submission, you may begin requesting status information. Submit requests via fax (301-443-8818) or via mail to: 510(k) Status Coordinator Division of Small Manufacturers Assistance (DSMA) (HFZ-220) Center for Devices and Radiological Health, FDA 5600 Fishers Lane Rockville, Maryland 20857 USA Because of staff limitations, we cannot answer telephone status requests.

o 510(k) status requests should include: (1) submitter's name and mailing address; (2) requester's name, affiliation with the 510(k) submitter, mailing address, fax number (if applicable), telephone number, and signature; and (3) 510(k) information, including product name, 510(k) number, date logged in by ODE (as identified in acknowledgment letter from ODE), and name of contact person identified on firm's 510(k) submission. Enclosed is a suggested format that you may use to ensure that you include all of the required information.

o Within three working days after DSMA receives a submitter's status request, DSMA will send the submitter a fax or letter that includes: (1) the branch to which the 510(k) has been assigned; (2) the last action, and date of that action, that CDRH has taken regarding the 510(k), e.g., logging in an amendment, preparing a decision letter; and (3) the position of the 510(k) in the reviewer's queue.

We request that 510(k) submitters make status inquiries no more than every four weeks. We do not have the resources to respond more frequently.

The SMDA also requires all persons submitting a premarket notification submission to include either (1) a summary of the safety and effectiveness information in the premarket notification submission upon which an equivalence determination could be based (510(k) summary), OR (2) a statement that safety and effectiveness information will be made available to interested persons upon request (510(k) statement). Safety and effectiveness information refers to information in the premarket notification submission, including adverse safety and effectiveness information, that is relevant to an assessment of substantial equivalence. The information could be descriptive information about the new ana 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 acknowledges that the law provides the 510(k) submitter an alternative, FDA encourages 510(k) submitters to provide a 510(k) statement to FDA and to make their safety and effectiveness information available to the public, excluding confidential manufacturing 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

5,-"' Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 /- Records processed under FOIA Request 2014-5115; Released 10/15/14

information .equires that FDA must make the 510(k) summary, or the source of _referred to in the 510(k) statement, publicly available within 30 days of we no making a substantial equivalence determination, we advise you that may under 21 CFR 807.95. longer honor any request for extended confidentiality asserts that Additionally, the new legislation also requires any person who their device is substantially equivalent to a class III device to (1) certify that he or she has conducted a reasonable search of all information known, or otherwise available, about the generic type of device, AND (2) provide effectiveness problems a summary description of the types of safety and 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 sufficiently comprehensive 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 certification in your premarket notification, please provide it as soon as possible. We cannot complete the review of your submission until you do so. Practice As of March 9, 1993, FDA has implemented the Good Manufacturing (GMP) Pre-Clearance Inspection Program for all class III devices that are A letter of being reviewed under the premarket notification program. substantial equivalence cannot be sent until the finished device have manufacturing site(s) and sterilization sites(s) as appropriate, that the bepi identified and FDA has determined manufacturer(s) iýiin compliance with the GMP regulation (21 CFR Part 820).

`Furthermore, the new legislation, section 522(x)(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 subsequently found to be substantially equivalent to an Aneurysm Clip, Annuloplasty Ring, Artificial Embolization Device, Automatic Implanted Cardioverter Defibrillator System, Cardiovascular Intravascular Filter, Cardiovascular Permanent Pacemaker Electrode (Lead), Central Nervous System Fluid Shunt, Coronary Vascular Stent, Implantable Pacemaker Pulse Generator, Implanted Diaphragmatic/Phrenic Nerve Stimulator, Intracardiac Patch or Pledget, Intravascular Occluding 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 surveillance and so notified of this determination in 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 surveillance or about this program, please contact the Postmarket Surveillance Studies Branch at (301) 227-8006.

Please note that the SMDA may have additional requirements affecting your device. You will be informed of these requirements as they become affective.

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lease remember that all correspondence concerning your submission MUST be "sent to the Document Mail Center (HFZ-401) at the above letterhead address. Correspondence sent 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 limitations we cannot accept telefaxed material as part of your official premarket notification submission, unless specifically requested of you by an FDA official.

Ifyou have procedural or policy questions, please contact the Division of Small Manufacturers Assistance at (301) 443-6597 or their toll-free number (800) 638-2041, or contact me at (301) 427-1190.

Sincerely yours,

Marjorie Shulman Supervisory Consumer Safety Officer Premarket Notification Staff Office of Device Evaluation Center for Devices and Radiological Health

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 /h933(2 / Bioclinical A SvYstemsInc.

Food and Drug Administration June 28, 1993.. Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, MD 20850 ,.z Re: 510(k) Notification a '1 Microbiological Culture Media

Attention: Document Control Clerk

BioClinical Systems, Inc. (BCS) is filing a 510(k) notification for the following microbiological culture medium/device:

1.0 Classification Name: Culture Media, for Isolation of Pathogenic Neisseria (83-JTY) Common/Usual Name: Microbiological Culture Media, Chocolate Agar Proprietary Name: Same as above

2.0 Establishment Regist. #: 1120183

3.0 Classification of Device: Culture medium for antimicrobial susceptibility tests are placed in Class II according to the Federal Register notice of November 9, 1982.

4.0 Performance Standards: As to this date, there are no performance standards established under Section 514 of the Act. 5.0 Labels/Labeling: Copies of package labeling are attached. (Attachment A)

6.0 Substantial Equivalence: BioClinical Systems Culture Media is substantially equivalent to culture media currently manufactured and marketed by numerous other media manufacturers in the United States (i.e. Becton Dickinson, Cockeysville, MD, Regional Media Labs, Lenexa, KS). Sample labeling from Becton Dickinson is attached. (Attachment B)

BioClinical Systems would appreciate your quick review of this 510(k) submission. Please contact us at the following number (301) 498-9550 if you have any questions or require additional information.

S'ncerely,

týr B a Po r Regulatory Affairs

" " 9040Questions?Junction Drive, ContactSuite FDA/CDRH/OCE/DIDOne AnnapolisJunction, at [email protected] 20701,USA (301)498-9550/FAX or 301-796-8118(301) 470-4129 Records processed under FOIA Request 2014-5115; Released 10/15/14

ATTACHMENT A

DEVICE SAMPLE LABELING

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

BioClinicalSystems, Inc. Product No. 1020 800-638-2625 Revision No. 00 PRODUCT INFORMATION AND QUALITY CONTROL SHEET CHOCOLATE AGAR

II. SUMMARY AND EXPLANATION VII. SPECIMEN COLLECTION Bacto GC Medium Base was designed in 1947. Christensen The quality of culture results depends primarily on the and Schoenlein demonstrated that this base, enriched with adequacy and condition of the specimen submitted for hemoglobin and supplements yielded accelerated early examination. Proper specimen collection techniques must growth of Neisseria gonorrhoeae.' This medium was be followed to ensure the most accurate culture results. improved upon by substituting a chemical supplement for Sterile swabs and collection containers should be used. the yeast concentrate.' In addition to aiding the growth of Plates should be inoculated promptly after specimen gonococci, other fastidious organisms, e.g. Haemophilus collection. If a delay in inoculation is unavoidable, transport species was also improved. medium should be employed. Specimens should be collected prior to the initiation of antimicrobial therapy. III.PRINCIPLES OF THE PROCEDURE Chocolate agar contains a GC agar base, bovine Detailed information on proper specimen collection may be materials.3"",s hemoglobin, and a chemically defined enrichment. Casein obtained from microbiology reference and meat peptones contained in the GC agar base provide the nitrogenous elements, phosphate buffers maintain the VIII. MATERIALS PROVIDED pH and corn starch neutralizes any toxic fatty acids that Chocolate Agar Plates and lot specific Quality Control may be present in the agar. Hemin (X factor) is provided by Certificate. the bovine hemoglobin, necessary for growth of Haemophilus species. The chemically defined enrichment IX. MATERIALS REQUIRED BUT NOT PROVIDED solution provides nicotinamide adenine dinucleotide/NAD (V Incubator maintaining 33-37°C. factor), vitamins, amino acids, co-enzymes, dextrose, ferric Ancillary culture media, reagents and laboratory equipment ions and other factors for improved growth of Neisseria as required. species. X. PROCEDURE V. TYPICAL FORMULA AND APPEARANCE Inoculate the specimen as soon as possible after it is Appearance = opaque, chocolate brown received in the laboratory. The streak plate method is used (Approximate formula' per liter of processed water) primarily to isolate pure cultures from specimens containing Pancreatic Digest of Casein 7.5g mixed flora. If material is being cultured directly from a Selected Meat Peptone 5.0 swab, roll the swab over a small area of the plate surface at Corn Starch 1.0 the edge (approximately 114 to 113 of the plate); then Dipotassium phosphate 4.0 streak in a zig-zag fashion with a sterile loop from this Monopotassium phosphate 1.0 inoculated area in two sections to cover the entire agar Sodium Chloride 5.0 surface; flaming or flipping loop between sections. Avoid Agar 12.0 applying excessive pressure to the agar surface during Hemoglobin 10.0 inoculation to prevent gouging and splitting of the agar Chocolate enrichment solution 10 ml media. (Note: Agar surfaces should be smooth and moist 'adjusted and/or supplemented to meet performance but free of excessive moisture which could cause confluent criteria. growth patterns.)

V. PRECAUTIONS Since many fastidious microorganisms require carbon This product is for IN VITRO diagnostic use only. Culture dioxide on primary isolation, plates should be incubated in specimens may contain microorganisms which can be an atmosphere of approximately 3-10% CO. (atmospheric potentially infectious to the user. Strict adherence to incubator or zip-lock bag with generator). Incubate plates aseptic techniques and established precautions against media side up at 33-37°C for 18-24 hours. microbiological hazards should be followed throughout the procedure. Carefully dispose of all items which contact XI. EXPECTEDRESULTS patient specimens or isolated bacteria. (See Material Safety NCCLS CONTROL ORGANISMS (ATCC STRAINS) Data Sheet for further information.) Neisseria gonorrhoeae Growth VI. STORAGEISHELF LIFE (ATCC 43069) Plated media should be stored at 2-8°C (36-46°F), media side up, in the unopened or resealed package protected Haemophilus influenzae Growth from light. DO NOT FREEZE OR EXPOSE TO HIGH (ATCC 10211) TEMPERATURES. Allow unopened plates to warm to room Streptococcus pneumoniae Growth temperature prior to inoculation. Prior to and during (ATCC 6305) inoculation procedures, plates should be handled in a manner that minimizes product exposure to the Neisseria meningiridis Growth environment. Product which has exceeded the assigned (ATCC 13090) expiration date noted on the label should not be used.

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 3! Records processed under FOIA Request 2014-5115; Released 10/15/14

X11.LABORATORY RESULTS 2. Daily, document that laboratory incubator This medium is intended to be used as a primary isolation temperature within the recommended main-tains range: medium. Presumptive identification of organisms may be 33-37°C. made on the basis of typical organism morphology and Gram stain. Definitive identification of certain organisms 11. QUALITY CONTROL and antimicrobial sensitivity determination requires further The following incoming inspection procedures must be testing. Additional biochemical information may be performed for each batch (batch = same lot, same 3,4.b obtained from reference microbiology texts. shipment) of culture media received in the laboratory

XIII. LIMITATIONS Inspect plates according to instructions contained The ability to detect microorganisms by culture techniques on the BioClinical Systems, Inc. "Quality Control Sheet." can be affected by the following factors: improper specimen Log (See also Section VI "STORAGE/ collection, storage and inoculation , initiation of antiinfective SHELF LIFE") therapy prior to specimen collection, improper culture incubation temperatures and atmospheres, improper length 2. Peel off the lower portion of a product bag label of culture incubation, and improper storage and handling of (BCS Quality Control Certificate) for the lot being culture media. accepted into the laboratory and affix it to the v Quality Control Log Sheet. Chocolate agar is an enriched medium. Pathogenic organisms may be overgrown by nonpathogenic or normal Initial and date the Quality Control Log Sheet. specimen flora. Note: Notify Technical Service immediately if media does XIV. REFERENCES not meet the inspection criteria. 1. Difco Manual, Dehydrated Culture Media and Reagents for Microbiology, 10th ed. 1984. Difco Laboratories, This media is not exempt from end user quality control Detroit, Mi. testing relating to media growth characteristics according to NCCLS Document M22A, Quality Assurance for 2. Power, D.A. led.) and P.J. McCuen. 1988. Manual of Commercially Prepared Microbiological Culture Media. BBL products and laboratory procedures, 6th ed. Becton Quality Control organisms maybe ordered by contacting our Dickinson Microbiology Systems, Cockeysville, MD. customer service department.

3. Finegold, S.M. and W.S. Martin. 1982. Bailey and Scott's Diagnostic Microbiology, 6th ed. C.V. Mosby TECHNICAL SERVICE Company, St, Louis. BioClinical Systems provides a toll free technical service line V.R. Jr. and H. M. 4. Koneman, E.S., S.D.Allen, Dowell, (1-800-638-2625) to assist with product usage. To receive Color Atlas and Textbook of Sommers. 1983. additional productinformation, procedural instructions, CLIA 2nd ed. J.6. Lippincot Company, Microbiology, manuals, QA/QC log sheets, Material Safety Data Sheets, Philadelphia. or to have technical questions answered; please call between the hours of 9:00 am to 5:00 pm EST. 5. Lennette, E.H., ed. 1985. Manual of Clinical Microbiology, 4th ed. American Society for Microbiology, BioClinical Systems, Inc. Washington, D.C. 9040 Junction Drive, Suite 1 Annapolis Junction, MD 20701 USER QUALITY ASSURANCE/ QUALITY CONTROL PROCEDURES 1-800-638-2625 AND INFORMATION June, 1993 The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), requires end-users of any laboratory diagnostic products to; a) register with the Health Care Financing Administration (HCFA), b) create procedure manual(s), and c) perform required quality assurance (QA) BIoClinical Systems,' AD regulations Qualify and quality control (QC). In addition there are BioClinical Systems is commiftec patient test personnel governing management, laboratory ongoing process of quality improverii and their training, and participation in proficiency testing will understand and meet the ever:: programs. The information is provided to the following help product and service requiremeiats users of this product conform to some of these regulations. customers to produce defect-fre Through the efforts and ideas of .'A For additional CLIA information, see the BioClinical Manual." every employee we will provide ii Systems, Inc. "CLIA Resource value to all customers.

I. QUALITY ASSURANCE The following quality assurance procedures must be performed to assure the product will perform according to its intended use within the assigned expiry date:

Daily, document that product storage refrigerator maintains temperature within the recommended range: 2-8°C. Product No. 1020 Rev. No.

0Q-3 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14

DEVICE IABEZ

UrýathIqle/ Catalog #: )Dý evice Name: MW

BIoClinical Aw Systems Inc. Prepared Media for the Growth of Microorganisms. For In-Vitro and Laboratory Use Only.

STORE

00 NOT IYKA FREEZE a°C

°C

t See Product InformationlQualityControl Sheet for Directions.Contact 1-800-63&2625to obtain a copy or for TechnicalService. CHOCOLATEAGAR CAT. NO. 1020

Samplesof this lot were tested and met or exceeded BCS specificationsand NCCLSStandards where relevant. A BioClinical Systems, Inc. 9040 JunctionDrive, Annapolis Junction, MD 20701

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ATTACHMENT B

-- SAMPLE LABELING/EQUIVALENT DEVICE(S)

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 Records processed under FOIA Request 2014-5115; Released 10/15/14 PROD.INFO. NO. P21169 - REV. 04

QUALITY CONTROL / PRODUCT INFORMATION

Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX®)t Chocolate II Agart (150 mm) Chocolate II Agar and Chocolate II Agart - I Plate® Chocolate II Agart - Quad Plate

QUALITYCONTROL PROCEDURES Additional Strains Utilized By BBL Neisseria gonorrhoeae Colonies small, opaque, INTRODUCTION ATCC 35201 grayish-white to colorless, Chocolate II Agar is an enriched medium for the raised, glistening and smooth and cultivation of Neisseria species. Prepared platesisola-tion Neisseria meningiddis Growth of Chocolate 11Agar are manufactured from pretested ATCC 13090 BBL® GC II Agar dehydrated base and appropriate Streptococcus Growth additives, including BBL© IsoVitaleX° Enrichment, in pneumoniae BBL disposable plastic Stackee, Space-Saving, 150 x ATCC 6305 15 mm-style, 1 Plate and Quad Plate dishes. Streptococcus Colonies small to medium, pyogenes white to gray, and may PERFORMANCE TEST PROCEDURE ATCC 19615 exhibit green discoloration 1. Inoculate representative samples with the cultures of the medium listed below: *Recommended organism strain for User Quality Control. a. Add 0.1 ml of a culture containing 30 to 300 CFU/0.1 ml to each plate and spread-inoculate III ADDITIONAL QUALITY CONTROL a sterile glass spreader. using 1. Examine plates as described under "Product b. Incubate plates at 35 ± 2°C in an aerobic Deterioration." atmosphere supplemented with carbon dioxide. 2. examine representative plates to assure that c. Include plates of a tested lot of Visually previously physical defects will not interfere with Chocolate 11 Agar as controls for all strains. any existing use. 2. Examine plates after 18 to 24 h for growth. 3. Determine the pH potentiometrically at room 3. Expected Results temperature for adherence to the specification of 7.2 (ATCC° NCCLS Control Organisms Strains) ± 0.2. *Neisseria gonorrhoeae Growth 4. Note the firmness of plates during the inoculation 143069) procedure. *Haemophdus Growth 5. Incubate uninoculated representative plates at 35 ± influenzae 2°C for 72 h and examine for microbial contamination. (10211) tMust be monitored by users, according to NCCLS M22-A.

March1992 1 of 3 0392067 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 CP Records processed under FOIA Request 2014-5115; Released 10/15/14 PRODUCT INFORMATION IsoVitaleX Enrichment Approximate Formula* Per Liter Purified Water !V INTENDED USE Vitamin B12 0.01 g Chocolate 1l Agar is an improved medium for use in L-Glutamine 10.0 qualitative procedures for the isolation and cultivation of Adenine 1.0 Guanine Hydrochloride 0.03 ý. fastidious microorganisms, especially Neisseria and .- Haemophilus species, from a variety .of clinical p-Aminobenzoic Acid 0.013 specimens. Nicotinamide Adenine Dinucleotide 0.25 Thiamine Pyrophosphate 0.1 V SUMMARY AND EXPLANATION Ferric Nitrate 0.02 0.003 Carpenter and Morton described an improved medium for Thiamine Hydrochloride L-Cysteine Hydrochloride 25.9 the isolation of the gonococcus in 24 h.' The efficiency L-Cystine 1.1 of this medium, GC Agar supplemented with hemoglobin Dextrose 100.0 and yeast concentrate, was demonstrated in a study of twelve media then in use for the isolation of this *Adjusted and/or supplemented as required to meet organism. The medium was improved by replacing the performance criteria. yeast concentrate with BBL© IsoVitaleX® Enrichment, a chemically defined supplement developed specially to Vlll PROCEDURE aid the growth of gonococci, although it has broad Material Provided Haernophilus.3-5 for other microorganisms, e.g., appli-cation Chocolate II Agar Through careful selection and pretesting of raw materials, Chocolate IIprepared plated medium promotes improved Materials Not Provided growth of gonococci and Haemophilus species. With Ancillary culture media, reagents and laboratory most strains of N. gonorrhoeae, visible growth on primary as required. equip-ment isolation is seen after incubation of 18 to 24 h. Instructions VI PRINCIPLES OF THE PROCEDURE The agar surface should be smooth and moist, but Chocolate II Agar contains an improved GC Agar base, without excessive moisture. bovine Enrichment. The GC hemoglobin and IsoVitaleX Streak the specimen as soon as possible after it is base contains nitrogenous nutrients in the form of casein received in the laboratory. Alternatively, if material is and meat peptones, phosphate buffer to maintainpH and being cultured directly from a swab, proceed as corn starch, which neutralizes toxic fatty acids that may follows:s be present in the agar. Hemoglobin provides X factor 1. Roll swab on the medium in a large "Z" to (hemin) for Haemophilus species. IsoVitaleX Enrichment directly is a defined supplement which provides V factor provide adequate exposure of swab to the medium for transfer of organisms. (nicotinamide adenine dinucleotide, NAD) for "Z" Haemophilus species and vitamins, amino acids, 2. Cross-streak the pattern with a sterile wire loop, in the clinic. If not done co-enzymes, dextrose; ferric ion and other factors which preferably previously, improve the growth of pathogenic Neisseria. should be done in the laboratory. cross-streaking 3. Place the culture as soon as possible in an aerobic VII REAGENTS environment enriched with carbon dioxide. 4. Incubate at 35 ± 2°C and examine after overnight Chocolate II Agar (GC 1l Agar with Hemoglobin and incubation and again after approximately 48 h. IsoVitaleX Enrichment) Formula* 5. Subcultures for identification of N. gonorrhoeae Approximate Per Liter Purified Water should be made within 18 to 24 h. Pancreatic Digest of Casein 7.5 g Selected Meat Peptone 7.5 Corn Starch 1.0 Dipotassium Phosphate 4.0 Monopotassium Phosphate 1.0 Sodium Chloride 5.0 Agar 12.0 Hemoglobin 10.0 IsoVitaleX Enrichment 10.0 ml *Adjusted and/or supplemented as required to meet performance criteria.

41 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 0392061 Records processed under FOIA Request 2014-5115; Released 10/15/14

P21169 REV. 04

IX RESULTS 3. Power, D.A. led.), and P.J. McCuen. 1988. Manual Typical colonial morphology on Chocolate II Agar is as of BBL products and laboratory procedures, 6th ed. follows: Becton Dickinson Microbiology Systems, Small (1mm), moist, pearly ville; Md. Cockeys-Haemophilus influenzae with a characteristic 4. Martin, J.E., T.E. Billings, J.F. Hackney, and J.D. "mousy" odor Thayer. 1967. Primary isolation of N. gonorrhoeae with a new commercial medium. Public Health Rep. Neisseria Small, grayish-white to gonorrhoeae colorless, mucoid 82:361-363. `C.R. Dawson, I. Hoshiwara, C. Medium to large, blue-gray, 5. Vastine, D.W., Neisseria T. and M. Messadi. 1974. mucoid Yonega, Daghfous, meningitidis of media for the isolation of HaemophilusCom-parison species from cases of seasonal conjunctivitis OF THE PROCEDURE X LIMITATION associated with severe endemic trachoma. Appl. II Agar is an enriched medium on which Chocolate Microbiol. 28:688-690. bacteria be overgrown with undesirable pathogenic may 6. Center for Disease Control. 1975. Criteria and nonpathogenic bacteria. or for the diagnosis of gonorrhea. U.S. Publictech-niques Health Service, Atlanta. XI REFERENCES 1. Carpenter, C.M., and H.E. Morton. 1947. An improved medium for isolation of the gonococcus in 24 hours. Proc. N.Y. State Assoc. Public Health Labs. 27.58-60. 2. Carpenter, C.M., M.A. Bucca, T.C. Buck, E.P. Casman, C.W. Christensen, E. Crowe, R. Drew, J. Hill, C.E. Lankford, H.E. Morton, L.R. Peizer, C.I. Shaw, and J.D. Thayer. 1949. Evaluation of twelve media for the isolation of the gonococcus. Am. J. Syphil. Gonorrh. Venereal Diseases 33:164-176.

-PR oýf BECTON CONSISTENTLY HIGHESTQUALITY MCKINSM Becton Dickinson Microbiology Systems 250 SchillingCircle Cockeysville, MD 21030 USA

3 of 3 0392069 Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 cle Records processed under FOIA Request 2014-5115; Released 10/15/14

ATTACHMENT C

SUBSTANTIAL EQUIVALENCE DATA

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ATTACHMENT C

DEVICE: CHOCOLATE AGAR

1.0 Safety and Effectiveness:

Chocolate Agar is classified as microbiological culture media. It is an enriched medium designed to isolate fastidious organisms, which include pathogenic Neisseria species, from clinical specimens. This product does not present any safety related issues.

2.0 Substantial Equivalence Data

2.1 Samples of BioClinical Systems (BCS) Chocolate Agar were tested in parallel with Becton Dickinson Microbiology Systems (BDMS) Chocolate Agar according to the recommended quality control procedures established by the National Committee for Clinical Laboratory Testing (NCCLS) guideline document M22-A, "Quality Assurance for Commercially Prepared Microbiological Culture Media .

2.2 The following laboratory data outlined in Table 1 establishes the substantial equivalence of these products.

Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118 ýlý Records processed under FOIA Request 2014-5115; Released 10/15/14

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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118