Atlas FDA

DIO

145 FDA 510(k) clearances · Product code

80 daysmedian time to decision
280 days90th percentile
145clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3250
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2011: 4 · 2015: 7 · 2016: 9 · 2017: 16 · 2018: 12 · 2019: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System (K213211)Carolina Liquid Chemistries Corp.2022-01-27
DRI Cocaine Metabolite Assay (K211973)Microgenics Corporation2021-09-24
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay (K191638)Medtest DX2020-03-12
DRI Cocaine Metabolite Assay (K181499)Microgenics Corporation2018-07-06
Emit II Plus Cocaine Metabolite Assay (K170293)Siemens Healthcare Diagnostics, Inc.2017-10-25
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (K163570)Carolina Liquid Chemistries Corporation2017-08-15
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (K162395)Mp Biomedicals, LLC2017-06-02
Quest Diagnostics HairCheck-DT (Cocaine) (K152232)Quest Diagnostics Incorporated2016-11-18
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) (K161214)Guangzhou Wondfo Biotech Co., Ltd.2016-06-27
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana (K153646)Safecare Biotech (Hangzhou) Co., Ltd.2016-03-18
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET (K142129)Biophor Diagnostics, Inc.2015-07-24
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set (K150925)Immunalysis Corporation2015-06-29
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (K142353)W.H.P.M., Inc.2014-10-07
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) (K141647)Healgen Scientific,, LLC2014-07-17
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (K131128)Omega Laboratories, Inc.2013-11-13
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) (K131754)Guangzhou Wondfo Biotech Co., Ltd.2013-07-31
RANDOX COCAINE METABOLITE (K113751)Randox Laboratories, Ltd.2012-05-08
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL (K121166)Guangzhou Wondfo Biotech Co., Ltd.2012-05-08
ORATECT ORAL FLUID DRUG SCREEN DEVICES (K103227)Branan Medical Corporation2012-04-11
QUICKSCREEN COCAINE 150 SCREENING TEST (K103295)Phamatech, Inc.2012-02-01
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (K112808)Omega Laboratories, Inc.2012-01-23
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) (K113501)Ameditech, Inc.2011-12-05
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS (K113139)Lin-Zhi International, Inc.2011-11-22
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P (K112071)Guangzhou Wondfo Biotech Co., Ltd.2011-09-23
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (K101742)Microgenics Corp.2011-04-08
ROCHE ORAL FLUID COCAINE (K101160)Roche Diagnostics2011-02-11
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 (K080436)Quantrx Biomedical Corporation2009-02-11
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA (K062929)Quest Diagnostics, Inc.2006-12-18
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062123)Ortho-Clinical Diagnostics, Inc.2006-11-16
RAPIDONE-COCAINE-150 TEST (K053422)American Bio Medica Corp.2006-06-15
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 (K053035)Acro Biotech, LLC2006-05-05
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS (K050945)Lin-Zhi International, Inc.2006-03-29
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS (K051578)Immunalysis Corporation2005-11-18
IMMUNALYSIS COCAINE ELISA FOR HAIR (K050465)Immunalysis Corporation2005-08-04
ONTRAK TESTCARD 9 (K050321)Varian, Inc.2005-04-18
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) (K033866)Lin-Zhi International, Inc.2004-04-07
LABONE COCAINE METABOLITE MICRO-PLATE EIA (K040198)Labone, Inc.2004-03-05
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE (K032903)ACON Laboratories, Inc.2004-02-17
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A (K033713)Dade Behring, Inc.2004-02-09
RANDOX EVIDENCE (K030360)Randox Laboratories, Ltd.2003-12-23
AML HAIRCHECK-DT (COCAINE) (K023626)Quest Diagnostics, Inc.2003-09-29
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC (K032057)Branan Medical Corp.2003-08-21
EMIT II PLUS COCAINE METABOLITE ASSAY (K031512)Dade Behring, Inc.2003-07-23
COZART EIA COCAINE ORAL FLIUD KIT (K030234)Cozart Bioscience , Ltd.2003-04-28
QUICKTOX MULTIPLE DRUG DIPCARD (K023489)Branan Medical Corp.2002-12-16
ONLINE DAT II COCAINE II (K023281)Roche Diagnostics Corp.2002-12-06
COBAS INTEGRA ONLINE DAT II COCAINE II (K023296)Roche Diagnostics Corp.2002-11-25
AMEDICA DRUG SCREEN COCAINE TEST (K022954)Amedica Biotech, Inc.2002-11-06
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 (K022355)Branan Medical Corp.2002-07-30
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC (K014067)Princeton BioMeditech Corp.2002-06-10
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC (K014069)Princeton BioMeditech Corp.2002-06-10
ACON ONE STEP DRUG SCREEN TEST CARD (K020771)ACON Laboratories, Inc.2002-05-15
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) (K020763)Lin-Zhi International, Inc.2002-05-10
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY (K020441)Dade Behring, Inc.2002-03-28
COCAINE (K013004)Abbott Laboratories2002-03-13
AMEDITECH IMMUTEST DRUG SCREEN COC (K011814)Ameditech, Inc.2001-10-22
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (K011962)Advantage Diagnostics Corp.2001-08-09
RADS (K011054)Chason Healthcare, LLC2001-07-30
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE (K010841)ACON Laboratories, Inc.2001-07-09
COCAINE DIPSTICK TEST, MODEL D747-A (K010239)Teco Diagnostics2001-06-25
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY (K011162)Syva Co., Dade Behring, Inc.2001-05-02
LIVESURE COCAINE SCREEN TEST (K010967)Pan Probe Biotech, Inc.2001-04-17
AT WORK DRUG TEST, MODEL 9177T AWT (K010833)Phamatech2001-04-11
AT HOME DRUG TEST, MODEL 9073 T (K010650)Phamatech2001-03-30
ADVANTAGE THC/COCAINE TEST (K003708)Advantage Diagnostics Corp.2001-01-22
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST (K002264)Branan Medical Corporation2000-11-27
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST (K994403)Alfa Scientific Designs, Inc.2000-08-14
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST (K994398)Alfa Scientific Designs, Inc.2000-07-27
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA (K001197)OraSure Technologies, Inc.2000-05-11
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A (K000467)Dade Behring, Inc.2000-04-14
SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST (K000350)Drug Detection Devices, Ltd.2000-04-11
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 (K994165)Roche Diagnostics Corp.2000-04-07
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (K993988)Syva Co.2000-01-27
AT HOME DRUG TEST, MODEL 9073 (K994219)Phamatech1999-12-30
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE (K993485)Sun Biomedical Laboratories, Inc.1999-12-27
QUICKPAC II ONE STEP COCAINE TEST (K992990)Syntron Bioresearch, Inc.1999-09-20
DRUGCHECK X MULTIDRUG SCREENING DEVICE (K992748)Syntron Bioresearch, Inc.1999-09-02
REDI-TEST COCAINE (K991110)Redwood Biotech, Inc.1999-07-26
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM (K992207)Syntron Bioresearch, Inc.1999-07-22
RAPIDONE - COCAINE TEST (K990822)American Bio Medica Corp.1999-07-15
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (K983697)Roche Diagnostic Systems, Inc.1998-12-11
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U (K982759)OraSure Technologies, Inc.1998-11-20
DBEST COCAINE TEST KIT (K983191)Ameritek, Inc.1998-11-18
ONTRAK TESTCUP-ER (K983388)Roche Diagnostic Systems, Inc.1998-11-18
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) (K982061)OraSure Technologies, Inc.1998-08-25
MICRO-STRIP FOR COCAINE METABOLITES (K981388)Microdiagnostics, Inc.1998-05-29
MECTEST (K973986)Meco Industries1998-04-24
DRUG CHECK (K980153)Texas Immunology, Inc.1998-03-27
RAPID DRUG SCREEN' 8 PANEL (K980872)American Bio Medica Corp.1998-03-20
STC COCAINE METABOLITE MICRO-PLATE EIA (K973651)OraSure Technologies, Inc.1998-01-02
QUIKPAC II ONE STEP COCAINE TEST (K972059)Drial Consultants, Inc.1997-08-28
AQ ONE STEP COCAINE TEST (K972384)Bionike Laboratories, Inc.1997-08-06
QUIKSTRIP ONE STEP COCAINE TEST (K971926)Drial Consultants, Inc.1997-07-14
RAPID DRUG SCREEN (K964900)American Bio Medica Corp.1997-04-14
IMMULITE COCAINE METABOLITE (K963918)Diagnostic Products Corp.1997-04-08
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) (K962353)Princeton BioMeditech Corp.1996-08-19
COCAINE METABOLITE EIA TEST (K960187)Diagnostic Reagents, Inc.1996-04-02
FRONTLINE COCAINE (K954496)Boehringer Mannheim Corp.1996-03-06
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI (K954571)Princeton BioMeditech Corp.1995-11-03
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET (K945549)Princeton BioMeditech Corp.1995-10-26
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