Product Code: DKZ FDA class 2 21 CFR 862.3100

Enzyme Immunoassay, Amphetamine

Clinical Toxicology

The Enzyme Immunoassay for Amphetamine is a clinical laboratory test system that uses enzyme-linked immunological techniques to detect and quantify amphetamine in patient specimens, primarily for toxicological screening. It is a Class 2 device requiring a 510(k) premarket notification to demonstrate substantial equivalence before marketing. The product code is DKZ, regulated under 21 CFR 862.3100, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

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510(k)s

225

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DKZ
Device Class: FDA class 2
Regulation Number: 862.3100
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 225 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240670	DRI Ecstasy Plus Assay	Oct 30, 2024	Substantially Equivalent	Microgenics Corporation
K233019	AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx	Dec 13, 2023	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.
K231137	Xenta Drug Screen Cup, Xenta Drug Screen Dipcard	May 19, 2023	Substantially Equivalent	Xenta Biomedical Science Co., Ltd.
K200363	Quidel Triage® TOX Drug Screen, 94600	Mar 11, 2020	Substantially Equivalent	Quidel Cardiovascular, Inc.
K191099	Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel	Oct 03, 2019	Substantially Equivalent	Atlas Medical
K182719	Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro	Jun 19, 2019	Substantially Equivalent	Quidel Cardiovascular, Inc.
K182738	Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)	Mar 27, 2019	Substantially Equivalent	Hangzhou AllTest Biotech Co., Ltd.
K180879	BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use	Dec 14, 2018	Substantially Equivalent	Shanghai Venture Bio-Tech Co., Ltd.
K181945	QuickScreen Pro Multi Drug Screening Test, Model 9395Z	Oct 18, 2018	Substantially Equivalent	Phamatech, Inc.
K173303	INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)	Feb 23, 2018	Substantially Equivalent	Alfa Scientific Designs, Inc.
K161251	CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests	Aug 30, 2016	Substantially Equivalent	Hangzhou Clongene Biotech Co., Ltd.
K152122	Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)	Jun 24, 2016	Substantially Equivalent	Alfa Scientific Designs, Inc.
K152908	UCP COMPACT DRUG TESTS	May 03, 2016	Substantially Equivalent	Ucp Biosciences, Inc.
K152590	ACCU NEWS Drug Screening Test Card/Urine Cup	Apr 15, 2016	Substantially Equivalent	Coretests, Inc.
K153465	AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)	Mar 31, 2016	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.
K152269	Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)	Sep 09, 2015	Substantially Equivalent	Healgen Scientific,, LLC
K151213	UCP Drug Test Mini Cups	Aug 21, 2015	Substantially Equivalent	Ucp Biosciences, Inc.
K142855	Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)	Jul 28, 2015	Substantially Equivalent	Omega Laboratories, Inc.
K141748	RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET	May 20, 2015	Substantially Equivalent	Biophor Diagnostics, Inc.
K143500	Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set	Feb 06, 2015	Substantially Equivalent	Immunalysis Corporation
K142800	Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard	Dec 11, 2014	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.
K142580	Chemtrue Multi-Panel DOA DIP Card Tests	Dec 01, 2014	Substantially Equivalent	Chemtron Biotech, Inc.
K141532	CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE	Jul 14, 2014	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K131069	QUICKSCREEN AMPHETINE 500 TEST	May 14, 2014	Substantially Equivalent	Phamatech, Inc.
K132812	UCP MULTI-DRUG TEST KEY CUPS	Mar 06, 2014	Substantially Equivalent	Ucp Biosciences, Inc.
K133968	WONDFO MULTI-DRUG URINE TEST CUP, PANEL	Feb 25, 2014	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K131653	LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS	Feb 04, 2014	Substantially Equivalent	Lin-Zhi International, Inc.
K131110	ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD	Jan 15, 2014	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.
K130082	GENPRIME DRUGS OF ABUSE READER SYSTEM	Dec 20, 2013	Substantially Equivalent	Genprime, Inc.
K131645	INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)	Oct 07, 2013	Substantially Equivalent	Alfa Scientific Designs, Inc.
K131811	UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS	Jul 19, 2013	Substantially Equivalent	Ucp Biosciences, Inc.
K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	Jun 17, 2013	Substantially Equivalent	Advin Biotech
K121065	POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE	May 24, 2013	Substantially Equivalent	Polymed Therapeutics, Inc.
K130463	UCP HOME DRUG SCREENING TEST; CARDS, CUPS	May 15, 2013	Substantially Equivalent	Ucp Biosciences, Inc.
K130811	PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE	May 02, 2013	Substantially Equivalent	Psychemedics Corp.
K123863	UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS	Jan 09, 2013	Substantially Equivalent	Ucp Biosciences, Inc.
K122961	WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)	Dec 21, 2012	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K122419	UCP HOME DRUG SCREENING TEST CUPS	Nov 30, 2012	Substantially Equivalent	Ucp Biosciences, Inc.
K122904	WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;	Nov 15, 2012	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K121987	WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST	Aug 01, 2012	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K121339	CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS	May 17, 2012	Substantially Equivalent	Chemtron Biotech, Inc.
K113046	AMEDITECH IMMUTEST MILTI-DRUG SCREEN	Nov 10, 2011	Substantially Equivalent	Ameditech, Inc.
K111560	WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST	Jul 15, 2011	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K110446	ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID	May 03, 2011	Substantially Equivalent	Roche Diagnostics
K101745	THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY	Apr 08, 2011	Substantially Equivalent	Microgenics Corp.
K092275	RANDOX ECSTASY (MDMA) ASSAY	Mar 01, 2011	Substantially Equivalent	Randox Laboratories, Ltd.
K102203	CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS	Jan 20, 2011	Substantially Equivalent	Chemtron Biotech, Inc.
K102210	LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS	Dec 28, 2010	Substantially Equivalent	Lin-Zhi International, Inc.
K093664	AMPHETAMINES II ASSAY	Jul 28, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K093114	THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY	May 12, 2010	Substantially Equivalent	Microgenics Corp.
K083764	AMPHETAMINES II	Feb 03, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K091588	UCP HOME DRUG SCREENING TESTS	Sep 04, 2009	Substantially Equivalent	Ucp Biosciences, Inc.
K080635	MEDTOXSCAN	Feb 13, 2009	Substantially Equivalent	Medtox Diagnostics, Inc.
K080057	IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL	Oct 31, 2008	Substantially Equivalent	Novx Systems, Inc.
K071489	HOMECHECK MULTIPLE DRUG CUP TEST	Mar 28, 2008	Substantially Equivalent	Tianjin New Bay Bioresearch Co., Ltd.
K063379	AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220	Dec 11, 2006	Substantially Equivalent	Amedica Biotech, Inc.
K062077	VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS	Nov 22, 2006	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K061617	FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST	Nov 22, 2006	Substantially Equivalent	Tianjin New Bay Bioresearch Co., Ltd.
K061718	INNOVACON SPECTRUM II TEST CARD	Nov 13, 2006	Substantially Equivalent	Innovacon, Inc.
K063024	LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS	Oct 30, 2006	Substantially Equivalent	Lin-Zhi International, Inc.
K061005	ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS	Oct 04, 2006	Substantially Equivalent	Applied Dna Technologies, Inc.
K060810	ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC	Aug 07, 2006	Substantially Equivalent	Ind Diagnostic, Inc.
K053359	RAPIDTOX	May 25, 2006	Substantially Equivalent	American Bio Medica Corp.
K053337	DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109	May 19, 2006	Substantially Equivalent	Dade Behring, Inc.
K052882	FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE	Feb 15, 2006	Substantially Equivalent	Tianjin New Bay Bioresearch Co., Ltd.
K053032	ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000	Feb 09, 2006	Substantially Equivalent	Acro Biotech, LLC
K052115	FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY	Dec 29, 2005	Substantially Equivalent	First Check Diagnostics, LLC
K053175	AMEDITECH DRUGSMARTCUP	Dec 08, 2005	Substantially Equivalent	Ameditech, Inc.
K051161	QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)	Nov 22, 2005	Substantially Equivalent	Quest Diagnostics, Inc.
K050394	SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS	Oct 25, 2005	Substantially Equivalent	Medtox Diagnostics, Inc.
K051579	IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS	Oct 21, 2005	Substantially Equivalent	Immunalysis Corporation
K051966	FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY	Sep 07, 2005	Substantially Equivalent	Worldwide Medical, LLC
K041696	RAPID READER	Jul 12, 2005	Substantially Equivalent	American Bio Medica Corp.
K051235	ON TRAK TESTCARD	Jun 08, 2005	Substantially Equivalent	Varian, Inc.
K050540	UCP RAPID DRUG SCREENING TESTS	Apr 29, 2005	Substantially Equivalent	Ucp Biosciences, Inc.
K050186	AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III	Mar 04, 2005	Substantially Equivalent	Ameditech, Inc.
K043028	EMIT II PLUS ECSTASY ASSAY	Jan 07, 2005	Substantially Equivalent	Dade Behring, Inc.
K041822	ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE	Sep 16, 2004	Substantially Equivalent	ACON Laboratories, Inc.
K041743	ACON TRI-FECT DRUG SCREEN TEST DEVICE	Sep 09, 2004	Substantially Equivalent	ACON Laboratories, Inc.
K041685	ACON MULTI-CLIN DRUG SCREEN TEST DEVICE	Aug 30, 2004	Substantially Equivalent	ACON Laboratories, Inc.
K033743	COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT	Jun 03, 2004	Substantially Equivalent	Cozart Bioscience , Ltd.
K032575	FIRST SIGN DRUG OF ABUSE SCREENING TEST	May 19, 2004	Substantially Equivalent	W.H.P.M., Inc.
K033566	MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062	May 17, 2004	Substantially Equivalent	Rapid Diagnostics, Inc.
K040350	RANDOX AMPHETAMINE CLASS ASSAY	May 12, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K040133	URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE	Apr 08, 2004	Substantially Equivalent	Dade Behring, Inc.
K040203	MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22	Mar 25, 2004	Substantially Equivalent	Branan Medical Corp.
K040092	AMEDITECH IMMU TEST DRUG SCREEN PANEL	Mar 08, 2004	Substantially Equivalent	Ameditech, Inc.
K033902	ONTRAK TESTCUP II AND ONSITE CUPKIT	Jan 20, 2004	Substantially Equivalent	Varian, Inc.
K033659	VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK	Jan 06, 2004	Substantially Equivalent	Varian, Inc.
K033094	ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)	Dec 19, 2003	Substantially Equivalent	Lin-Zhi International, Inc.
K031759	ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD	Aug 04, 2003	Substantially Equivalent	ACON Laboratories, Inc.
K031004	SYVA EMIT II PLUS AMPHETAMINES ASSAY	Jun 06, 2003	Substantially Equivalent	Dade Behring, Inc.
K023712	ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST	Jan 31, 2003	Substantially Equivalent	Advantage Diagnostics Corp.
K023104	AMEDICA DRUG SCREEN AMPHETAMINE TEST	Dec 16, 2002	Substantially Equivalent	Amedica Biotech, Inc.
K022564	INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST	Aug 30, 2002	Substantially Equivalent	Alfa Scientific Designs, Inc.
K021114	'RAPIDTEC' 5A MULTIPLE DIP TEST	Jul 23, 2002	Substantially Equivalent	American Bio Medica Corp.
K020869	FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)	Jun 11, 2002	Substantially Equivalent	Worldwide Medical Corp.
K021006	STARTOX DRUG OF ABUSE SCREENING TEST	Jun 10, 2002	Substantially Equivalent	Starplex Scientific, Inc.
K020395	AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)	Jun 04, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K014247	TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002	Jun 03, 2002	Substantially Equivalent	Biosite Incorporated
K020313	ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD; ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE	May 08, 2002	Substantially Equivalent	Acon Laboratories Co.
K012745	TRIAGE TOX DRUG SCREEN, CATALOG #94000	Jan 10, 2002	Substantially Equivalent	Biosite Incorporated
K012484	AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE	Nov 30, 2001	Substantially Equivalent	Ameditech, Inc.
K012396	ONTRAK TESTCARD 9	Nov 05, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K011952	DRUGS OF ABUSE MULTI-TEST STRIP	Oct 25, 2001	Substantially Equivalent	Microdiagnostics, Inc.
K012110	DRI ECSTASY ENZYME IMMUNOASSAY	Aug 27, 2001	Substantially Equivalent	Microgenics Corp.
K012257	EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229	Aug 03, 2001	Substantially Equivalent	Syva Co.
K011673	ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE	Jul 31, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K012159	RAPID DRUG SCREEN	Jul 25, 2001	Substantially Equivalent	American Bio Medica Corp.
K011499	VISUALINE AMPHETAMINE DIPSTRIP ASSAY	Jul 17, 2001	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K011609	LIVESURE AMPHETAMINE SCREEN TEST	Jun 08, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K010177	VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY	May 17, 2001	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K003809	RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS	Apr 20, 2001	Substantially Equivalent	Rapid Diagnostics, Inc.
K010564	VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO	Apr 05, 2001	Substantially Equivalent	Medtox Diagnostics, Inc.
K010645	AT HOME DRUG TEST, MODEL 9063 T	Mar 30, 2001	Substantially Equivalent	Phamatech
K004034	MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12	Mar 08, 2001	Substantially Equivalent	Branan Medical Corp.
K003865	COBAS INTEGRA AMPHETAMINES	Feb 28, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K002266	BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST	Nov 22, 2000	Substantially Equivalent	Branan Medical Corporation
K002447	MODIFICATION TO RAPID DRUG SCREEN 9-PANEL	Nov 16, 2000	Substantially Equivalent	American Bio Medica Corp.
K994395	INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST	Aug 07, 2000	Substantially Equivalent	Alfa Scientific Designs, Inc.
K994399	INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST	Aug 04, 2000	Substantially Equivalent	Alfa Scientific Designs, Inc.
K001421	ONTRAK TESTCUP 501, MODEL 3016633	Jul 12, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K001417	ONTRAK TESTCUP 502, MODEL 3016641	Jun 29, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K001397	QUICKSCREEN PRO DRUG CUP, MODEL 9195X	May 26, 2000	Substantially Equivalent	Phamatech
K001225	ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.	May 17, 2000	Substantially Equivalent	Princeton BioMeditech Corp.
K000606	SYNCHRON SYSTEMS AMPHETAMINE REAGENT	May 05, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K994380	CEDIA DAU AMPHASSURE ASSAY	May 02, 2000	Substantially Equivalent	Microgenics Corp.
K000400	SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST	Apr 18, 2000	Substantially Equivalent	Drug Detection Devices, Ltd.
K000460	URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A	Apr 14, 2000	Substantially Equivalent	Dade Behring, Inc.
K992918	STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I	Apr 03, 2000	Substantially Equivalent	OraSure Technologies, Inc.
K992632	IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5	Jan 27, 2000	Substantially Equivalent	Diagnostic Products Corp.
K994237	AT HOME DRUG TEST, MODEL 9063	Dec 30, 1999	Substantially Equivalent	Phamatech
K990681	DBSET MULTIDRUG SCREEN TEST KIT	Jul 15, 1999	Substantially Equivalent	Ameritek, Inc.
K992033	MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL	Jun 30, 1999	Substantially Equivalent	American Bio Medica Corp.
K990325	QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE	Jun 24, 1999	Substantially Equivalent	Syntron Bioresearch, Inc.
K990399	ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8	Apr 15, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K990418	ONTRAK TESTCUP-ER M2K	Apr 13, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K984525	RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST	Feb 26, 1999	Substantially Equivalent	American Bio Medica Corp.
K990337	ONTRAK TESTCUP-5 M2K	Feb 23, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K983770	'RAPID DRUG SCREEN' 9-PANEL	Dec 31, 1998	Substantially Equivalent	American Bio Medica Corp.
K983699	MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES	Dec 11, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K981705	'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME	Aug 27, 1998	Substantially Equivalent	American Bio Medica Corp.
K981504	DBEST AMPHETAMINES TEST KIT	Aug 06, 1998	Substantially Equivalent	Ameritek, Inc.
K981197	ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST	Jun 16, 1998	Substantially Equivalent	Tcpi, Inc.
K980865	QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131	Apr 01, 1998	Substantially Equivalent	Phamatech
K974611	MICRO-STRIP FOR AMPHETAMINE METABOLITES	Mar 20, 1998	Substantially Equivalent	Microdiagnostics, Inc.
K972989	STC METHAMPHETAMINE MICRO-PLATE EIA	Jan 28, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K973784	TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS	Dec 03, 1997	Substantially Equivalent	Biosite Incorporated
K973726	FINGERPRINT DRUG SCREENING DEVICE	Nov 06, 1997	Substantially Equivalent	Applied Technology Ventures, LLC
K973075	ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON	Oct 09, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K972891	ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION	Oct 01, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K972032	VISUALINE II METHAMPHETIMINE	Aug 12, 1997	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K970395	QUIKSTRIP ONE STEP METHAMPHETAMINE	Jun 26, 1997	Substantially Equivalent	Drial Consultants, Inc.
K971218	QUIKSTRIP ONE STEP AMPHETAMINE TEST	May 30, 1997	Substantially Equivalent	Drial Consultants, Inc.
K971109	QUIKPAC II ONE STEP AMPHETAMINE TEST	May 14, 1997	Substantially Equivalent	Drial Consultants, Inc.
K970724	QUICKPAC II ONE STEP METHAMPHETAMINE TEST	May 13, 1997	Substantially Equivalent	Drial Consultants, Inc.
K970265	ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST	Apr 08, 1997	Substantially Equivalent	Drial Consultants, Inc.
K962411	ONTRAK TESTCUP AMPHETAMINES	Oct 07, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K955934	TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000	Feb 16, 1996	Substantially Equivalent	Biosite Incorporated
K955935	TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS	Feb 15, 1996	Substantially Equivalent	Biosite Incorporated
K953115	AXSYM AMPHETAMINE/METHAMPHETAMINE II	Oct 06, 1995	Substantially Equivalent	Abbott Laboratories
K935573	AMPHETAMINES MICRO-PLATE EIA	Jul 14, 1995	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K951154	CEDIA DAU AMPHETAMINES ASSAY	May 08, 1995	Substantially Equivalent	Microgenics Corp.
K942836	FINGERPRINT-DOA	May 01, 1995	Substantially Equivalent	Fingerprint Bioteck, Inc.
K945610	ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP	Apr 13, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K950135	URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE	Mar 30, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K943439	ABUSIGN DOA4	Feb 22, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K935352	EMIT(R) IIC AMPHETAMINE ASSAY	Feb 22, 1995	Substantially Equivalent	Syva Co.
K944604	CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS	Dec 07, 1994	Substantially Equivalent	Beckman-Diagnostic Systems Group
K943993	CEDIA DAU AMPHETAMINES ASSAY	Oct 21, 1994	Substantially Equivalent	Microgenics Corp.
K935052	MICROLINE SCREEN FOR AMPHETAMINE	Sep 16, 1994	Substantially Equivalent	Drug Screening Systems, Inc.
K941372	CEDIA DAU AMPHETAMINES ASSAY	Jul 20, 1994	Substantially Equivalent	Microgenics Corp.
K935042	ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT	Jan 25, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K934891	AMPHETAMINES EIA ASSAY MODIFICATION	Jan 13, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K932304	MICRO EIA FOR AMPHETAMINE METABOLITES	Dec 07, 1993	Substantially Equivalent	Microdiagnostics, Inc.
K934693	AMPHETAMINE TEST SYSTEM	Nov 22, 1993	Substantially Equivalent	U.S. Drug Testing, Inc.
K933052	ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED	Sep 15, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K931498	SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY	Jul 20, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K930690	STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA	Apr 16, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K924476	THE TRIAGE II	Jan 22, 1993	Substantially Equivalent	Biosite Incorporated
K921998	ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED	May 26, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K921554	AMPHETAMINES EIA TEST	May 04, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K920018	ACCUSCREEN ASSAY	Mar 19, 1992	Substantially Equivalent	Jk Research
K920507	EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY	Feb 27, 1992	Substantially Equivalent	Syva Co.
K913738	IL TEST(TM) AMPHETAMINE	Nov 07, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K914146	BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE	Oct 11, 1991	Substantially Equivalent	Biosite Incorporated
K912758	ABUSCREEN ONLINE FOR AMPHETAMINES	Jul 26, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910658	ABUSCREEN ONTRAK FOR METHAMPHETAMINE	Apr 03, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910278	ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)	Apr 03, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910739	TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)	Mar 21, 1991	Substantially Equivalent	V-Tech, Inc.
K910738	TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)	Mar 19, 1991	Substantially Equivalent	V-Tech, Inc.
K910756	ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)	Mar 11, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K905700	EZ-SCREEN: AMPHETAMINES	Jan 15, 1991	Substantially Equivalent	Environmental Diagnostics, Inc.
K903993	MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT	Dec 20, 1990	Substantially Equivalent	Immunotech Corp.
K904115	HYCOR ACCUPINCH METHAMPHETAMINE TEST	Nov 28, 1990	Substantially Equivalent	Hycor Biomedical, Inc.
K904451	MILENIA (TM) METHAMPHETAMINE	Nov 21, 1990	Substantially Equivalent	Diagnostic Products Corp.
K903824	DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY	Sep 27, 1990	Substantially Equivalent	Technicon Instruments Corp.
K902979	MILENIA (TM) AMPHETAMINE	Sep 07, 1990	Substantially Equivalent	Diagnostic Products Corp.
K900995	EMIT D.A.U. AMPHETAMINE CLASS ASSAY	Apr 20, 1990	Substantially Equivalent	Syva Co.
K900143	ABUSCREEN FP FOR METHAMPHETAMINE	Mar 09, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K895210	LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II	Sep 25, 1989	Substantially Equivalent	Abbott Laboratories
K890692	ADX AMPHETAMINE/METHAMPHEAMINE	Aug 25, 1989	Substantially Equivalent	Abbott Laboratories
K894465	ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE	Aug 15, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K894404	EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE	Aug 11, 1989	Substantially Equivalent	Syva Co.
K890886	ABUSCREEN FP FOR AMPHETAMINE	Mar 10, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K883707	TDX AMPHETAMINE/METHAMPHETAMINE II	Oct 20, 1988	Substantially Equivalent	Abbott Laboratories
K884022	EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE	Oct 11, 1988	Substantially Equivalent	Syva Co.
K882589	EMIT HVA AMPHETAMINE ASSAY	Aug 02, 1988	Substantially Equivalent	Syva Co.
K874770	TDX (R) AMPHETAMINE CLASS	Apr 21, 1988	Substantially Equivalent	Abbott Laboratories
K880013	REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.	Mar 01, 1988	Substantially Equivalent	Abbott Laboratories
K874836	ABUSCREEN(R) EIA AMPHETAMINE	Feb 16, 1988	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K874486	REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K874274	REVISED LABELING FOR AMPHETAMINE TEST KIT	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K874273	REVISED LABELING FOR AMPHETAMINE TEST KIT	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K874080	REVISED LABELING FOR SYVA AMPHETAMINE ASSAY	Oct 29, 1987	Substantially Equivalent	Syva Co.
K873755	LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K873622	ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH	Oct 02, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K871696	DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5	Jun 05, 1987	Substantially Equivalent	Diagnostic Products Corp.
K853879	TDX AMPHETAMINE METHAMPHETAMINE	Oct 28, 1985	Substantially Equivalent	Abbott Laboratories
K842674	EMIT D.A.U. AMPHETAMINE ASSAY	Sep 26, 1984	Substantially Equivalent	Syva Co.
K843458	EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT	Sep 20, 1984	Substantially Equivalent	Syva Co.
K833579	MODIF. OF EMIT URINE AMPHETAMINE	Jan 26, 1984	Substantially Equivalent	Syva Co.
K802623	EMIT-STM AMPHETAMINE ASSAY	Nov 12, 1980	Substantially Equivalent	Syva Co.
K760936	EMIT AMPHETAMINE CONFIRMATION REAGENT	Nov 19, 1976	Substantially Equivalent	Syva Co.
K760196	ASSAY, AMPHET. NDC#11711-0127-1 COULTER	Aug 03, 1976	Substantially Equivalent	Coulter Electronics, Inc.