FDA 510(k) Applications for Medical Device Product Code "DIO"
(Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K013004 | ABBOTT LABORATORIES | COCAINE | 03/13/2002 |
| K010841 | ACON LABORATORIES, INC. | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE | 07/09/2001 |
| K032903 | ACON LABORATORIES, INC. | ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE | 02/17/2004 |
| K020771 | ACON LABORATORIES, INC. | ACON ONE STEP DRUG SCREEN TEST CARD | 05/15/2002 |
| K053035 | ACRO BIOTECH LLC. | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 | 05/05/2006 |
| K011962 | ADVANTAGE DIAGNOSTICS CORP. | ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST | 08/09/2001 |
| K003708 | ADVANTAGE DIAGNOSTICS CORP. | ADVANTAGE THC/COCAINE TEST | 01/22/2001 |
| K994398 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST | 07/27/2000 |
| K994403 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST | 08/14/2000 |
| K022954 | AMEDICA BIOTECH, INC. | AMEDICA DRUG SCREEN COCAINE TEST | 11/06/2002 |
| K113501 | AMEDITECH, INC. | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) | 12/05/2011 |
| K011814 | AMEDITECH, INC. | AMEDITECH IMMUTEST DRUG SCREEN COC | 10/22/2001 |
| K964900 | AMERICAN BIO MEDICA CORP. | RAPID DRUG SCREEN | 04/14/1997 |
| K980872 | AMERICAN BIO MEDICA CORP. | RAPID DRUG SCREEN' 8 PANEL | 03/20/1998 |
| K990822 | AMERICAN BIO MEDICA CORP. | RAPIDONE - COCAINE TEST | 07/15/1999 |
| K053422 | AMERICAN BIO MEDICA CORP. | RAPIDONE-COCAINE-150 TEST | 06/15/2006 |
| K983191 | AMERITEK, INC. | DBEST COCAINE TEST KIT | 11/18/1998 |
| K972384 | BIONIKE LABORATORIES, INC. | AQ ONE STEP COCAINE TEST | 08/06/1997 |
| K142129 | BIOPHOR DIAGNOSTICS, INC. | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET | 07/24/2015 |
| K954496 | BOEHRINGER MANNHEIM CORP. | FRONTLINE COCAINE | 03/06/1996 |
| K023489 | BRANAN MEDICAL CORP. | QUICKTOX MULTIPLE DRUG DIPCARD | 12/16/2002 |
| K022355 | BRANAN MEDICAL CORP. | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 | 07/30/2002 |
| K032057 | BRANAN MEDICAL CORP. | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC | 08/21/2003 |
| K002264 | BRANAN MEDICAL CORPORATION | BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST | 11/27/2000 |
| K103227 | BRANAN MEDICAL CORPORATION | ORATECT ORAL FLUID DRUG SCREEN DEVICES | 04/11/2012 |
| K163570 | Carolina Liquid Chemistries Corporation | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | 08/15/2017 |
| K213211 | Carolina Liquid Chemistries, Corp. | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | 01/27/2022 |
| K011054 | CHASON HEALTHCARE, LLC. | RADS | 07/30/2001 |
| K030234 | COZART BIOSCIENCE LTD. | COZART EIA COCAINE ORAL FLIUD KIT | 04/28/2003 |
| K031512 | DADE BEHRING, INC. | EMIT II PLUS COCAINE METABOLITE ASSAY | 07/23/2003 |
| K020441 | DADE BEHRING, INC. | EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY | 03/28/2002 |
| K000467 | DADE BEHRING, INC. | URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A | 04/14/2000 |
| K033713 | DADE BEHRING, INC. | URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A | 02/09/2004 |
| K963918 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE COCAINE METABOLITE | 04/08/1997 |
| K960187 | DIAGNOSTIC REAGENTS, INC. | COCAINE METABOLITE EIA TEST | 04/02/1996 |
| K972059 | DRIAL CONSULTANTS, INC. | QUIKPAC II ONE STEP COCAINE TEST | 08/28/1997 |
| K971926 | DRIAL CONSULTANTS, INC. | QUIKSTRIP ONE STEP COCAINE TEST | 07/14/1997 |
| K000350 | DRUG DETECTION DEVICES, LTD. | SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST | 04/11/2000 |
| K161214 | GUANGZHOU WONDFO BIOTECH CO., LTD. | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) | 06/27/2016 |
| K131754 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) | 07/31/2013 |
| K112071 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P | 09/23/2011 |
| K121166 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL | 05/08/2012 |
| K141647 | HEALGEN SCIENTIFIC, LLC | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD) | 07/17/2014 |
| K150925 | Immunalysis Corporation | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | 06/29/2015 |
| K050465 | Immunalysis Corporation | IMMUNALYSIS COCAINE ELISA FOR HAIR | 08/04/2005 |
| K051578 | Immunalysis Corporation | IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS | 11/18/2005 |
| K040198 | LABONE, INC. | LABONE COCAINE METABOLITE MICRO-PLATE EIA | 03/05/2004 |
| K033866 | Lin-Zhi International, Inc. | CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) | 04/07/2004 |
| K020763 | Lin-Zhi International, Inc. | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) | 05/10/2002 |
| K113139 | Lin-Zhi International, Inc. | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | 11/22/2011 |
| K050945 | Lin-Zhi International, Inc. | ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS | 03/29/2006 |
| K973986 | MECO INDUSTRIES | MECTEST | 04/24/1998 |
| K191638 | MedTest Dx | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | 03/12/2020 |
| K981388 | MICRODIAGNOSTICS, INC. | MICRO-STRIP FOR COCAINE METABOLITES | 05/29/1998 |
| K101742 | MICROGENICS CORP. | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | 04/08/2011 |
| K181499 | Microgenics Corporation | DRI Cocaine Metabolite Assay | 07/06/2018 |
| K211973 | Microgenics Corporation | DRI Cocaine Metabolite Assay | 09/24/2021 |
| K162395 | MP BIOMEDICALS, LLC | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | 06/02/2017 |
| K112808 | OMEGA LABORATORIES, INC. | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | 01/23/2012 |
| K131128 | OMEGA LABORATORIES, INC. | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | 11/13/2013 |
| K982759 | ORASURE TECHNOLOGIES, INC. | AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U | 11/20/1998 |
| K001197 | ORASURE TECHNOLOGIES, INC. | COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA | 05/11/2000 |
| K973651 | ORASURE TECHNOLOGIES, INC. | STC COCAINE METABOLITE MICRO-PLATE EIA | 01/02/1998 |
| K982061 | ORASURE TECHNOLOGIES, INC. | STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE) | 08/25/1998 |
| K062123 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV | 11/16/2006 |
| K010967 | PAN PROBE BIOTECH, INC. | LIVESURE COCAINE SCREEN TEST | 04/17/2001 |
| K994219 | PHAMATECH | AT HOME DRUG TEST, MODEL 9073 | 12/30/1999 |
| K010650 | PHAMATECH | AT HOME DRUG TEST, MODEL 9073 T | 03/30/2001 |
| K010833 | PHAMATECH | AT WORK DRUG TEST, MODEL 9177T AWT | 04/11/2001 |
| K103295 | PHAMATECH INC. | QUICKSCREEN COCAINE 150 SCREENING TEST | 02/01/2012 |
| K962353 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) | 08/19/1996 |
| K014069 | PRINCETON BIOMEDITECH CORP. | LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC | 06/10/2002 |
| K014067 | PRINCETON BIOMEDITECH CORP. | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC | 06/10/2002 |
| K080436 | QUANTRX BIOMEDICAL CORPORATION | RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 | 02/11/2009 |
| K152232 | Quest Diagnostics Incorporated | Quest Diagnostics HairCheck-DT (Cocaine) | 11/18/2016 |
| K023626 | QUEST DIAGNOSTICS, INC. | AML HAIRCHECK-DT (COCAINE) | 09/29/2003 |
| K062929 | QUEST DIAGNOSTICS, INC. | QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA | 12/18/2006 |
| K113751 | RANDOX LABORATORIES, LTD. | RANDOX COCAINE METABOLITE | 05/08/2012 |
| K030360 | RANDOX LABORATORIES, LTD. | RANDOX EVIDENCE | 12/23/2003 |
| K991110 | REDWOOD BIOTECH, INC. | REDI-TEST COCAINE | 07/26/1999 |
| K983697 | ROCHE DIAGNOSTIC SYSTEMS, INC. | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | 12/11/1998 |
| K983388 | ROCHE DIAGNOSTIC SYSTEMS, INC. | ONTRAK TESTCUP-ER | 11/18/1998 |
| K101160 | Roche Diagnostics | ROCHE ORAL FLUID COCAINE | 02/11/2011 |
| K023296 | ROCHE DIAGNOSTICS CORP. | COBAS INTEGRA ONLINE DAT II COCAINE II | 11/25/2002 |
| K023281 | ROCHE DIAGNOSTICS CORP. | ONLINE DAT II COCAINE II | 12/06/2002 |
| K994165 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 | 04/07/2000 |
| K153646 | SAFECARE BIOTECH (HANGZHOU)CO.,LTD. | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana | 03/18/2016 |
| K170293 | SIEMENS HEALTHCARE DIAGNOSTICS INC. | Emit II Plus Cocaine Metabolite Assay | 10/25/2017 |
| K993485 | SUN BIOMEDICAL LABORATORIES, INC. | VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE | 12/27/1999 |
| K992748 | SYNTRON BIORESEARCH, INC. | DRUGCHECK X MULTIDRUG SCREENING DEVICE | 09/02/1999 |
| K992990 | SYNTRON BIORESEARCH, INC. | QUICKPAC II ONE STEP COCAINE TEST | 09/20/1999 |
| K992207 | SYNTRON BIORESEARCH, INC. | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM | 07/22/1999 |
| K993988 | SYVA CO. | SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL | 01/27/2000 |
| K011162 | SYVA CO., DADE BEHRING, INC. | MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY | 05/02/2001 |
| K010239 | TECO DIAGNOSTICS | COCAINE DIPSTICK TEST, MODEL D747-A | 06/25/2001 |
| K980153 | TEXAS IMMUNOLOGY, INC. | DRUG CHECK | 03/27/1998 |
| K050321 | VARIAN INC | ONTRAK TESTCARD 9 | 04/18/2005 |
| K142353 | W.H.P.M., Inc. | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | 10/07/2014 |
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