First Check • To confirm preliminary positive• results obtainedby theFirst The second step isconfirming theresults withGas • This test provides onlypreliminary results andisthefirst step• in Product Instructions in thelid. lab to confirm preliminary positive results ofthedrugsincluded steps outlinedintheseinstructions. There isnocost to utilize our Check our certified laboratory. Chromatography-Tandem Mass Spectrometry (LC-MS/MS) at Chromatography-Mass Spectrometry (GC-MS) orLiquid a two-step process for identifyingdrugsinurine. and 7prescription drugs. own home. This test candetect thepossible useofupto 7illicit fast, accurate andreliable drugtesting intheprivacy ofyour Collection Cup FOLLOW THESESTEPS: WHEN YOU AREREADY TO TEST Identification Label • Plastic Transportation Bag • Pre-addressed MailingBox • The following materials may beusedto sendanindividualurinesampleto alaboratory for confirmation testing andare We recommend allPreliminary Positive Results besentto ourlaboratory for free confidential confirmatory testing. PROCEDURE FORCONFIRMATION ® SHIPPING YOUR FIRST CHECK®SAMPLETO THELAB included inthekit. chromatography/massGas spectrometry (GC/MS) isconsidered thegoldstandard inlaboratory testing for most drugs. HomeDrugTest Kit,usetheincludedmailerandfollow QUESTIONS ANDANSWERS most drugs. chromatography-tandem mass spectrometry (LC-MS/MS) isconsidered thegoldstandard inlaboratory testing for to ourlaboratory for free confidential confirmatory testing. chromatography/mass Gas spectrometry (GC-MS) andliquid The First Check 2 Negative Result. urine that closelyresembles thedrug.Keep inmindthat nomatter how faint theDrugline, itisstill considered a of reasons suchas:how diluted theurineis,pHorprotein level oftheurine, orinterference from ametabolite inthe testing isrequired. Itispossible that theintensity ofthelineswillvary amongthedrugs beingtested for dueto avariety No. Any linenext to theword Drug(or D), nomatter how darkorlight,isconsidered aNegative Result andnofurther 1 Results are available 24/7 once they have beenprocessed viaeitheroftheabove retrieval methods. • You willneedtheidentification numberto access theconfirmation result. • Call1-888-788-5716 orvisitwww.firstcheckfamily.com andgoto theLabResults tab. • Results willbeready in5to 7days after thesampleisreceived inour Laboratory. • RETRIEVING YOUR CONFIDENTIAL LABORATORY RESULTS • Open foil pouch.Remove Test• Lidfrom Collect fresh urineintheCollection Cup. • Step 1:Prepare theTest The DrugLineislighter thantheControl Line. Doesthismeansome drug ispresent? What ismeantby aPreliminary Positive Result? Twist thelidonto thecup. The cuplidmust Step 2:Screw on theLid AFTER lidissnug. it a quarter turn tightly by twisting IMPORTANT: Cuplidmust besecured be closedtightly. HOME DRUGTEST pouch. Discard desiccant. urine level line. Make sure theurineisabove theminimum ® HomeDrugTests offer avariety ofsolutionsfor NOTE: You willneedto pay for postage to mailyour sampleto theLab. Someshippinglocations may require Place thespecimeninto thePre-Addressed MailerBox andsecure itwithPacking Tape. Samplesshouldbesent Place thelabeledFirst CheckDrug Test into thePlastic Transportation Bagandsealthebag. Attach thelower portionoftheIdentification Labelto thedesignated location onthissheetandstore inasafe place. Make sure thelidistwisted tightly. Attach theTop portionoftheIdentification Label(withbarcode) to the Step 3:Place Test inBox Step 2:Place Test inBag Step 1:AttachIdentification Label PAID into any mailbox. you to place specimeninto anothershippingbox andaffixaMailingLabel.Drop theshipping box withPOSTAGE within 24 hoursofcollection. Collection Cup, andplace acheckmarkinthebox for thedrug(s) that gave aPreliminary Positive Result. PLACE IDENTIFICATION LABELHERE ® HomeDrugTest isconsidered a“screening test”. We recommend allpreliminary Positive Results besent Minimum

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C P ® NOTE: Urinemay contain infectious soap andwater after handlingsample. diseases, always wash your handswith Foil Pouch Test Lid BEFORE YOUTEST Store theFirst CheckHomeDrugTest at room temperature STORAGE • Identification Label • Plastic Transportation Bag • Pre-addressed Mailingbox Set asidetheseitems, you willonlyneedtheseifyou shipthe • Product Instructions • Collection Cup • Test Lid(infoil pouch) The following materials are for testing anindividualurinesample TESTING MATERIALS Donotusethistest ifyou are color-blind. • Contaminated ortainted urinesamplemay give false results. • Certain foods ormedications may causethetest to give false • The test isfor onetimeuseonly. Itisnotreusable.• • DoNotOpentheTest Liduntilyou• are ready to perform Have awatch, clockortimeravailable. • Read theseinstructions completely. • in your home: sample for confidential confirmatory labtesting: 59˚F to 86˚F(15˚Cto 30˚C). First Check Results Key Drug Line Drug Name(s) Tilt thecuponitslegsto activate thetest. Step 3:Activate theTest but do notread themafter 8minutes. You can read your test results at 5minutes, results. the pouch. Donot usetest ifthepouchistorn or punctured. the test. Do not usetest ifitisbeyond the expiration date printed on IMPORTANT: withoutthisIdentification Label,we will number to retrieve your confidential results. be unableto test your sample. You willneedthis Test Legs ® Lid: Ctrl

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2: OXY 1: MDMA id 1: MDMA Control Drug 1 Invalid 2: OXY Drug 2 2: PPX 1: PCP 2: PPX 1: PCP Drug 2 Drug 1 Control MINUTES 5 Test Legs Test Strip Control Line 18 in NOTE: Any urinewithapreliminary positive result shouldbesentto ourlaboratory for confirmation usingtheincludedmailerbox. to alaboratory for confirmation. Note: Any urine with preliminary positive results shouldbesent No lineindicates aPreliminary Positive result. negativeresult. Note: Any test line, even a very faint test line, is considered a The appearance ofalineindicates aNegative result. For D1(Drug1)and D2(Drug2)regions: test results are Invalid for bothD1andD2onthat strip. Invalid result. Ifatest strip doesnothave alineintheCtrlregion, The appearance ofalineindicates avalid result. Nolinemeansan For Ctrl(Control) region: The D2region shows theresult for Drug2. of atest result. The D1region shows theresult for Drug1. Each strip contains two drugtests. The Ctrlregion shows validity UNDERSTANDING YOUR TEST – INTERPRETATION OF RESULTS The Test Lidhas7 Test Strips intotal. Eachhas2DrugNamesper Test Strip. They will beidentifiedasDrug1and2. The complete First Check®HomeDrug Test kittests for 14 drugs, 7illicitandprescription. Ctrl

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Control Drug2 Drug2 Drug1 Drug1 Negative healthcare professional to discuss options for treating substance abuse. If positive results are confirmed, please contact your doctor or 2: COC 1: THC 2: COC 1: THC M-F 8:30am-5:00pmEastern Time. Call ourtoll-free HelpLineat 1-888-788-5716 Questions? Our professional staff isavailable to assist you. Visit usat www.firstcheckfamily.com to learnmore aboutFirst Check HELP ANDSUPPORT The First Check or otherliquids,leadingto afalse result. Itisbest that you closelysupervisetheentire samplecollection process. being tested. Samplescanbe“adulterated” (i.e. contaminated ortampered with)usinghouseholdproducts suchasbleach If you are testing someoneelse, keep inmindthat First Check Test andcauseaPreliminary Positive Result. Certain foods andover-the counter medications orprescription drugsmay cross-reach withtheFirst Check testing. The test willonlygive accurate results onfresh humanurinesamples.Oldordiluted urinesamplesmay notbesuitablefor 6 any drugsthat may beinthesystem. However, First Check Use first morningurinewhenpossible asittends to bethemost concentrated urineoftheday, makingitbest for detecting 5 Ctrl). Disregard results after 8minutes. You canread your results after 5minutes aslongared orpinkcolored linehasappeared next to theword Control (or 4 unsure aboutyour results pleasere-test usinganew First Check If you have questions aboutyour results call1-888-788-5716 to speakwithoneofourFirst Checkrepresentatives. Ifyou are appears next to theword Drug. Negative whenatest orpinkcolored lineappearsnext to theword Drug.The result is Preliminary Positive whenNOline The test isworking properly aslongared orpinkcolored lineappearsnext to theword Control (or Ctrl).The result is 3 QUESTIONS ANDANSWERS • If itissuspected that thesamplemay have beentampered with,anew specimenshouldbecollected. • A positive drugresult doesnotindicate thefrequency ortimeofdruguse, nordoesitdistinguish between drugsand • There isapossibility that technical orprocedural errors aswell asothersubstances incertain foods andmedication may • Positive results indicate thepresence ofdrug/metabolites onlyanddonotindicate ormeasure intoxication. • The assay isdesignedfor usewithhumanurineonly. LIMITATIONS OFTHETEST tion ofadrug,thelevel ofintoxication, norisitto beusedfor legalpurposes. 2: COC 1: THC 2: COC 1: THC certain foods and/or medications. interfere withthetest andcausefalse results. 2: COC 1: THC 2: COC 1: THC How do Iknow iftheFirst Check®HomeDrugTest worked properly? What ifIamunsure of theresult? When isthebest timeto test? Control Are there any factors that can affect thetest result? How soon can Iread my results? firstcheckfamily.com DETECTION LEVELSANDAPPROXIMATE DETECTIONTIMES 2 1 Drug2 Drug1 2: MET 1: OPI 2: MET 1: OPI Preliminary Positive

Cut-off level isthelowest drugconcentration intheurinethat canbedetected by theFirst Check 2: MET 1: OPI Drug clearance rates are dependentonmany factors suchasfrequency ofdruguse, theamountofdrugtaken, metabolismrates, andeven bodyfat content. 2: MET 1: OPI 2: MET 1: OPI 2: MET 1: OPI RESULTS KEY Marijuana Drug

Amphetamine Opiates Ecstasy Benzodiazepines Propoxyphene Oxycodone Tricyclic Antidepressants Buprenorphine 2: BZO 1: AMP P/N: 002662-11 1/18 002662-11 P/N: U.S.A. in Made companies. of group Alere the of trademarks are Check First and Logo Alere The reserved. rights All Alere. 02453. © 2017 MA Waltham, LLC Diagnostics, Check First for Manufactured 30˚C). to (15˚C 86˚F to 59˚F at freeze. Store not Do test. reuse not -do only use time One use. internal for not only, use diagnostic vitro in For 2: BZO 1: AMP 2: BZO 1: AMP Community Anti-DrugCoalitions ofAmerica:http://www.cadca.org National Institute onDrugAbuse:http://www.drugabuse.gov Substance AbuseandMentalHealthServices Administration: http://www.samhsa.gov Other Websites for Information: 2: BZO 1: AMP 2: BZO 1: AMP 2: MTD 1: BAR

www.notmykid.org 2: BZO 1: AMP 2: BZO 1: AMP 2: MTD 1: BAR 2: BZO 1: AMP Control Drug2 Drug1 2: TCA 1: BUPG 1: BUPG 2: MTD 1: BAR 2: MTD 1: BAR 2: TCA ® 2: MTD 1: BAR 2: OXY 1: MDMA 1: MDMA 2: MTD 1: BAR Invalid 2: OXY 1: BAR 2: MTD 1: BAR 2: MTD 2: PPX 1: PCP 2: PPX 1: PCP 2: TCA 1: BUPG 2: TCA 1: BUPG ® 1: BUPG 2: TCA 1: BUPG Drug 2 Drug 1 Control HomeDrugTest provides ascreening result only;andisnotdesignedto determine theactualconcentra - 2: TCA 2: TCA 1: BUPG 2: TCA 1: BUPG 2: OXY 1: MDMA ® 2: OXY 1: MDMA 2: OXY 1: MDMA 2: OXY 1: MDMA 2: OXY 1: MDMA 2: PPX 1: PCP 2: PPX 1: PCP 2: PPX 1: PCP 2: PPX 1: PCP

2: PPX 1: PCP  Phencyclidine (PCP) (AMP) Ecstasy (MDMA) Methamphetamine (MET) Opiates (heroin) (OPI) Cocaine (COC) Marijuana (THC) 7 Illicit:

14 DrugsTested: negative youth behavior includingsubstance useandabuse. with theknowledge andcourage to identifyandprevent Empowering andeducating youth, families andcommunities Example #1: all tests. Therefore, itis regions onalltest strips. appearing inbothD1andD2 Positive Therefore, itis on thesixthtest strip. appearing intheD2region Example #3: other tests are etIetfir Cut-offLevel Test Identifier for OXY test. All MDMA

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There isnoline Negative Preliminary Negative. for 7 Prescription: Propoxyphene (PPX) Buprenorphine (BUPG) Oxycodone (OXY) Methadone (MTD) Benzodiazepines (BZO) Barbituates (BAR) Tricyclic Antidepressants (TCA) ® HomeDrugTest may beusedany timeofday. ® shows validity for eachstrip D2 HomeDrugTests are onlyasaccurate astheurinesample 1000 ng/ml D1 300 ng/ml 500 ng/ml 500 ng/ml 300 ng/ml 300 ng/ml 300 ng/ml 500 ng/ml 300 ng/ml 100 ng/ml 150 ng/ml 50 ng/ml ® 25 ng/ml 10 ng/ml HomeDrugTest. region: shows results for region: shows results for

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2: OXY 1: MDMA 2: OXY 1: MDMAMDMA Ctrl D2 2 2: OXY D1

Detection Time Drug 2 Drug 2: OXY 1: MDMA 1 Drug 2: PPX 1: PCP 2: PPX 1: PCP 2: PPX 1: PCP 2: PPXPPX 1: PCPPCP 2: PPX 1: PCP 2: COC 1: THC 2: COC 1: THC Therefore, itis on theseventh test strip. appearing intheCtrlregion Example #4: other tests are both PCPandPPX tests. All Positive Therefore, itis on thefirst test strip. appearing intheD1region Example #2: other tests are 1-3 weeks

7-14 days 2: MET 1: OPI 2-4 days 2-3 days 2-3 days 2-3 days 2-7 days 2-7 days ® 1-4 days 1-6 days 1-3 days 1-3 days 1-2 days 1-7 days

HomeDrug 2: MET 1: OPI P/N 1/18 002662-11 INSERT TEST 14 DRUG FIRST CHECK INVERNESS

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SUBSTRATE 2: PPX 1: PCP 01.15.2018 18” x25”DIELINE N/A N/A N/A 3510

25 in SPECIFICITY FOR PROFESSIONAL USE ® First Check® Home Drug Test is used in professional and clinical settings. The following information and instructions are for The specificity for the First Check Home Drug Test was determined by testing various drugs, drug metabolites, structurally related compounds, and Professional Use Only. Please refer to the reverse side of this page to reference instructions for Home Use. other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine. The effect of specimens with various pH (4.5–9) and specific gravity (1.005–1.030) ranges was also evaluated and found not to interfere with the First Check® Home Drug Test. For in vitro diagnostic use INTENDED USE The following compounds produced positive results when tested at or above the concentrations listed below. The calibrator for each test is marked with an asterisk (*). The First Check® Home Drug Test is a screening test for the rapid qualitative detection of multiple drugs and/or drug metabolites in human urine at or above the following cutoff concentrations: AMP 500 ng/ml THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml Compound ng/ml Compound ng/ml COC Benzoylecgonine 150 ng/ml d- * 500 Phentermine 1,000 OPI Morphine 300 ng/ml l-Amphetamine 20,000 β-Phenylethylamine 80,000 d,l-3,4-MDA 1,500 MET d-Methamphetamine 500 ng/ml AMP d-Amphetamine 500 ng/ml BAR 300 ng/ml BZO Oxazepam 300 ng/ml Compound ng/ml Compound ng/ml BAR Secobarbital 300 ng/ml Allobarbital 1,500 Butalbital 300 Alphenal 400 Butethal 400 MTD Methadone 300 ng/ml Amobarbital 1,500 400 BUPG Buprenorphine Glucuronide 10 ng/ml Aprobarbital 400 400 TCA 1000 ng/ml Barbital 400 Secobarbital * 300 MDMA 3,4-Methylenedioxymethamphetamine 500 ng/ml Butabarbital 400 OXY Oxycodone 100 ng/ml BZO 300 ng/ml PCP Phencyclidine 25 ng/ml Compound ng/ml Compound ng/ml PPX Propoxyphene 300 ng/ml α-Hydroxy Alprazolam 50 Lorazepam 1,500 Alprazolam 150 Lormetazepam 1,000 ® This test provides visual qualitative results and is intended for over-the-counter and prescription point-of-care use. The First Check Home Drug Test is Bromazepam 800 Medazepam 2,000 available in multiple drug analyte combinations. Chlordiazepoxide 2,000 Nitrazepam 1,000 This test provides only preliminary results and is the first step in a two-step process for identifying drugs in urine. The second step is confirming the Clobazam 200 Nordiazepam 100 results at a certified laboratory. To confirm preliminary positive results obtained by the First Check® Home Drug Test, a more specific alternative method Clonazepam 4,000 Oxazepam * 300 such as Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) must be used. Clinical Delorazepam 6,000 Phenazepam 1,000 consideration and professional judgment must be applied to any drug test result, particularly when a preliminary positive result is indicated. Diazepam 150 Prazepam 1,000 Estazolam 300 Temazepam 150 TEST PRINCIPLE Flunitrazepam 1,000 Triazolam 1,500 Flurazepam 300 The First Check® family of urine drug screen tests is based on the principle of the highly specific immunochemical reactions between antigens and antibodies, which are used for the analysis of specific substances in urine. The First Check® Home Drug Test is based on a competitive immunoassay BUPG 10ng/ml procedure in which immobilized drug conjugates compete with the drug(s) present in urine for limited binding sites of the antibody conjugated to colloidal Compound ng/ml Compound ng/ml gold. If there is drug or drug metabolite in the urine sample, the binding sites of the antibody become saturated and the antibody-colloidal gold Buprenorphine 100 Norbuprenorphine 100 Buprenorphine Glucuronide * 10 Norbuprenorphine conjugate cannot bind to the specific test region. The absence of a color band indicates a positive result for that particular test. If there is no drug or Glucuronide 100 drug metabolite present to compete for the binding sites of the colored colloidal gold conjugate, a visible color band forms at the specific test region COC 150 ng/ml indicating a negative result for that particular test. A control band with a different antigen/antibody reaction should always appear regardless of the Compound ng/ml Compound ng/ml presence of drug or metabolite. Benzoylecgonine * 150 Ecgonine 65,000

SPECIMEN COLLECTION AND HANDLING MDMA 500 ng/ml Compound ng/ml Compound ng/ml Fresh urine does not require any special handling or pretreatment. A fresh urine sample should be collected in the specimen container provided. Urine d,l-3,4-MDA 2,000 d,l-3,4-MDMA * 500 samples should be tested as soon as possible after collection, preferably within the same day. Specimens that have been refrigerated or frozen must be d,l-3,4-MDEA 250 d-Methamphetamine 50,000 brought to room temperature and mixed thoroughly prior to testing. MET 500 ng/ml Note: All materials coming into contact with urine specimens should be handled and disposed of as if potentially infectious. Avoid direct contact and Compound ng/ml Compound ng/ml follow good laboratory practice. Ephedrine 10,000 d-Methamphetamine * 500 p-Hydroxymethamphetamine 1,750 l-Methamphetamine 25,000 QUALITY CONTROL d,l-3,4-MDMA 1,000 Procaine 50,000 Internal control: The First Check® Home Drug Test has built-in internal procedural controls. The appearance of the control band is considered an internal d,l-3,4-MDEA 20,000 Trimethobenzamide 75,000 procedural control. This band should always appear if adequate sample volume is used and the testing procedure is followed. Additionally, the MTD 300 ng/ml background color should become clear and provide distinct test result. If the control band does not appear then the test is invalid. The test should be Compound ng/ml Compound ng/ml repeated using a new device. Doxylamine 50,000 Methadone * 300 2-Ethylidene-1,5-Dimethyl- 75,000 External control: It is recommended that negative and positive urine controls be used to initially test each new lot of product to ensure proper kit 1-3,3-Diphenylpyrolidine 50,000 performance. The same assay procedure should be followed with external control materials as with a urine specimen. If external controls do not produce the expected results, do not run test specimens. Follow the proper federal, state and local guidelines when running external controls. OPI 300 ng/ml Quality control testing at regular intervals is a good Compound ng/ml Compound ng/ml 6-Acetylmorphine 500 Hydrocodone 1,000 laboratory practice and may be required by federal, state or GC-MS GC-MS GC-MS GC-MS GC-MS % Agreement Drug Test Neg. < -50% -50% Cutoff to > +50% w/ GC-MS 6-Acetylcodeine 600 Hydromorphone 400 local guidelines. Always check with the appropriate to Cutoff +50% Neg (-) Pos (+) Codeine 300 Morphine * 300 licensing or accrediting bodies to ensure that the quality Dihydrocodeine 500 Morphine-3-β-D-Glucuronide 500 program employed meets the established standards. THC Pos. (+) 0 0 1 6 35 Ethyl morphine 300 Nalorphine 5,000 50 Neg. (-) 36 2 4 0 0 97.7% 100% Heroin 100 PERFORMANCE CHARACTERISTICS COC Pos. (+) 0 0 3 3 37 150 Neg. (-) 36 0 2 1 0 92.7% 97.6% OXY 100 ng/ml PRECISION Compound ng/ml Compound ng/ml OPI Pos. (+) 0 0 3 7 34 6-Acetylcodeine 15,000 Oxymorphone 3,000 A study was conducted at two laboratories and one physician 92.5% 100% ® 300 Neg. (-) 36 0 1 0 0 Codeine 5,000 Oxycodone * 100 office in an effort to determine the precision of the First Check Dihydrocodeine 2,000 Hydromorphone 25,000 MET Pos. (+) 0 0 0 5 67 Home Drug Test over 12 or more consecutive days. Testing was Hydrocodone 300 Ethyl Morphine 5,000 500 Neg. (-) 36 2 4 3 0 100% 96.0% conducted on the Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methamphetamine, AMP Pos. (+) 0 0 2 5 36 PCP 25 ng/ml 95.1% 100% Methylenedioxymeth-amphetamine, Methadone, Opiates, 500 Neg. (-) 36 1 2 0 0 Compound ng/ml Compound ng/ml 4-Hydroxy Phencyclidine 500 Phencyclidine * 25 Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic BZO Pos. (+) 0 0 3 4 39 Metaphit 500 Phencyclidine Morpholine 50,000 Antidepressants assays by operators using three different lots of 300 Neg. (-) 36 0 1 0 0 92.5% 100% product to demonstrate the within-run, between-run and BAR Pos. (+) 0 0 1 6 33 PPX 300ng/ml between-operator precision. An identical panel of coded 300 Neg. (-) 36 0 3 2 0 97.5% 95.1% Compound ng/ml Compound ng/ml samples, containing drugs at the concentration of ± 50% cut-off Propoxyphene * 300 Norpropoxyphene 500 MTD Pos. (+) 0 0 0 3 36 level was labeled as a blind and tested at each site. The 100% 97.5% 300 Neg. (-) 36 0 4 1 0 TCA 1000 ng/ml correlation with expected results was >99% across all lots and Compound ng/ml Compound ng/ml BUPG Pos. (+) 0 0 1 4 38 sites (with a 95% confidence interval). 1,000 1,000 10 Neg. (-) 36 0 3 1 0 97.5% 97.7% ACCURACY 7,500 Nortriptyline * 1,000 TCA Pos. (+) 0 0 0 27 11 1,500 50,000 ® The accuracy of the First Check Home Drug Test was 1000 Neg. (-) 36 0 4 3 0 100% 92.7% 750 Promazine 10,000 evaluated in comparison to the results from GC-MS or LC-MS 1,000 350 MDMA Pos. (+) 0 0 1 3 40 750 1,500 analysis. Thirty-six (36) negative drug-free urine samples were 500 Neg. (-) 36 0 3 1 0 97.5% 97.7% collected from volunteer donors and tested with both the First THC 50 ng/ml Check® Home Drug Test and the GC-MS or LC-MS method. Of OXY Pos. (+) 0 0 2 6 38 100 Neg. (-) 36 0 4 0 0 95.2% 100% Compound ng/ml Compound ng/ml the 36 negative urine samples tested, all were found negative by Cannabidiol 100,000 11-Hydroxy-Δ9-THC 2,500 PCP Pos. (+) 0 0 0 3 36 Cannabinol 50,000 Δ-8-Tetrahydrocannabinol 7,000 both methods. Additionally, for each drug test, a minimum of 40 100% 95.1% clinical urine samples previously analyzed by GC-MS or LC-MS 25 Neg. (-) 36 0 4 2 0 11-nor-Δ8-THC-9-COOH 50 Δ-9-Tetrahydrocannabinol 10,500 11-nor-Δ9-THC-9-COOH * 50 method with known concentration(s) of drug(s) values were blind PPX Pos. (+) 0 0 2 4 36 95.0% 100% labeled and evaluated. The results are summarized in chart: 300 Neg. (-) 36 0 2 0 0

CONSUMER STUDY A consumer study was conducted to determine the performance of the device when used by untrained, laypersons following only the instructions in the BIBLIOGRAPHY OF SUGGESTED READING product labeling. A total of 153 participants read a total of 5460 assays during the study and 5228 of those 5460 assays were interpreted correctly. Each 1. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, Biomedical Publications, Davis, CA, 1982. assay was tested by these participants using spiked solutions targeted to 0%, 25%, 50%, 75%, 125%, 150%, and 175% of the assay cutoff level. At 2. Urine testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA), Research Monograph 73, 1986. concentrations ≤50% cutoff and ≥150% cutoff, participants correctly interpreted the assays greater than 99% of the time. 3. Wong, R., The Current Status of Drug Testing in the US Workforce, Am. Clin. Lab., 2002; 21(1): 21-23 INTERFERENCE 4. Wong, R., The Effect of Adulterants on Urine Screen for Drugs of Abuse: Detection by an On-site Dipstick Device, Am. Clin. Lab., 2002; 21(3); 14-18 The following compounds were found not to cross-react when tested at concentrations up to 100 µg/ml (100,000 ng/ml). 5. Young, D.S. et. al., Clinical Chemistry, 21 (9), 1975. 6. U.S. Dept. of Transportation, Procedures for Transportation Workplace Drug and Testing Programs. Federal Register, 1999 Dec.; 64(236); 69076 Acetaminophen Tetracycline 7. U.S. Dept. of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs. Federal Register, 2001 Aug.; 66(162): 43876 Acetone Δ8-THC (except THC assay) 8. Fed. Register, Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, 53, 69, 11970–11979, 1988. Acetylsalicylic acid (Aspirin) Δ9-THC (except THC assay) 9. Liu, Ray H. and Goldberger, Bruce A., Handbook of Workplace Drug Testing, AACC Press (1995). 6-Acetylcodeine (except MOP & OXY assay) Alprazolam (except BZO assay) 6-Acetylmorphine (except MOP assay) Amitriptyline (except TCA assay) 10. Gilman, A. G. and Goodman, L. S., The Pharmacological Basis of Therapeutics, eds. MacMillan Publishing, New York, NY, 1980. Amoxicillin Amobarbital (except BAR assay) 11. McBay, A.J. Clin. Chem. 33, 33B-40B, 1987. Albumin 12. Ringsrud, K.M and Linne, J.J., Urinalysis and Body Fluids, A color Text and Atlas, Mosby-Year Book, Inc., 1995. Allobarbital (except BAR assay) d-Amphetamine (except AMP assay) 13. Baselt RC. Disposition of toxic Drugs and chemicals in Man. 6th Ed. Biomedical Publ., Davis, CA. 2002; 129 Alphenal (except BAR assay) l-Amphetamine (except AMP assay) Aspartame Ampicillin Atropine Apomorphine Barbital (except BAR assay) Aprobarbital (except BAR assay) Benzilic acid l-Ascorbic Acid (Vitamin C) Benzocaine (Ethyl p-Aminobenzoate) α-Hydroxy Alprazolam (except BZO assay) Benzoic acid 4-Hydroxy Phencyclidine (except PCP assay) Benzoylecgonine (except COC assay) p-Hydroxymethamphetamine (except MET assay) Benzphetamine 11-Hydroxy-Δ-9-THC (except THC assay) Bilirubin Ibuprofen Bromazepam (except BZO assay) Imipramine (except TCA assay) d- d,l-Isoproterenol Buprenorphine (except BUPG assay) Butabarbital (except BAR assay) Lidocaine Butalbital (except BAR assay) Lorazepam (except BZO assay) Butethal (except BAR assay) Lormetazepam (except BZO assay) Caffeine Medazepam (except BZO assay) Cannabidiol (except THC assay) Meperidine Cannabinol (except THC assay) Metaphit (except PCP assay) Chlordiazepoxide (except BZO assay) Methadone (except MTD assay) Chloroquine d-Methamphetamine (except MET & MDMA assay) d,l-Chlorpheniramine l-Methamphetamine (except MET assay) Methaqualone Cholesterol Methoxyphenamine Clobazam (except BZO assay) (1R,2S) N-Methyl-Ephedrine Clomipramine (except TCA assay) 2-Methylamine-Propiophenone Clonazepam (except BZO assay) d,l-3,4-Methylenedioxyamphetamine (except AMP & MDMA assays) Cocaine d,l-3,4-methylenedioxyethylamphet (except MET & MDMA assays) Codeine (except MOP & OXY assays) d,l-3,4-Methylenedioxymethamphetamine (except MET& MDMA assays) Cortisone l-Cotinine Morphine (except MOP assay) Creatine Morphine-3-ß-D-Glucuronide (except MOP assay) Creatinine Nalidixic acid Cyclobenzaprine (except TCA assay) Nalorphine (except for MOP assay) Delorazepam (except BZO assay) Deoxycorticosterone d-Naproxen Desipramine (except TCA assay) Niacinamide Nitrazepam (except BZO assay) Diazepam (except BZO assay) Nordiazepam (except BZO assay) Dihydrocodeine (except MOP & OXY assay) Nordoxepin (except TCA assay) 4-Dimethylaminoantipyrine Nicotine, (S)- Norepinephrine Dopamine (3-Hydroxytyramine) Norethindrone Doxepin (except TCA assay) Norpropoxyphene (except PPX assay) Doxylamine (except MTD assay) Nortriptyline (except TCA assay) Ecgonine (except COC assay) Oxalic Acid Ecgonine Methyl Ester Oxazepam (except BZO assay) l-Epinephrine Oxolinic acid d,l-Ephedrine (except MET assay) Oxycodone (except OXY assay) Erythromycin Oxymorphone (except OXY assay) Estazolam (except BZO assay) Papaverine β-Estradiol Penicillin-G (Benzylpenicillin) Estrone-3-Sulfate Ethanol Pentobarbital (except BAR assay) Ethyl Morphine (except MOP & OXY assay) Perphenazine (except TCA assay) Ethyl-p-aminobenzoate Phenazepam (except BZO assay) 2-Ethylidene-1,5-Dimethyl-1-3,3-Diphenylpyrolidone (except MTD assay) Phencyclidine (except PCP assay) Flunitrazepam (except BZO assay) Phencyclidine Morpholine (except PCP assay) Flurazepam (except BZO assay) Pheniramine (except MTD assay) Phenobarbital (except BAR assay) Glucose Phenothiazine (Thiodiphenylamine) Phentermine (except AMP assay) Gentisic acid Phenylephrine Glutethimide β-Phenylethylamine (except AMP assay) Guaiacol Glyceryl Ether Prednisolone Hemoglobin Heroin (except MOP assay) Prazepam (except BZO assay) Hippuric acid Procaine (except MET assay) Hydrochlorothizide Promazine (except TCA assay) Hydrocodone (except MOP & OXY assays) Hydrocortisone Propoxyphene (except PPX assay) Hydromorphone (except MOP & OXY assays) 11-nor-Δ8-THC-9-Carboxylic Acid (except THC assay) Protriptyline (except TCA assay) 11-nor-Δ-9-THC-9-Carboxylic Acid (except THC assay) d-Pseudoephedrine Thiamine Pyrrolidine Thioridazine Triazolam (except BZO assay) Quinine Ranitidine Trimethobenzamide (except MET assay) Riboflavin Trimipramine (except TCA assay) Salicylic acid Tryptamine Secobarbital (except BAR assay) d,l-Tryptophan Serotonin Tyramine d,l-Tyrosine Sodium Chloride Uric Acid Sulfamethazine Verapamil Sulindac Zomepirac Temazepam (except BZO assay)