DIO · Class II · 21 CFR 862.3250

FDA Product Code DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Cocaine use disorder and acute intoxication require rapid laboratory confirmation. FDA product code DIO covers enzyme immunoassay systems for cocaine and cocaine metabolite detection.

These tests detect benzoylecgonine — the primary urinary metabolite of cocaine — in biological specimens. They are used in emergency toxicology screening, workplace drug testing, and substance abuse treatment monitoring.

DIO devices are Class II medical devices, regulated under 21 CFR 862.3250 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and Princeton BioMeditech Corp..

145
Total
145
Cleared
117d
Avg days
1984
Since
145 devices
25–48 of 145
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742
Microgenics Corp.
Toxicology · 290d
Cleared Feb 11, 2011
ROCHE ORAL FLUID COCAINE
K101160
Roche Diagnostics
Chemistry · 291d
Cleared Feb 11, 2009
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
K080436
Quantrx Biomedical Corporation
Toxicology · 358d
Cleared Dec 18, 2006
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
K062929
Quest Diagnostics, Inc.
Toxicology · 81d
Cleared Nov 16, 2006
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K062123
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d
Cleared Jun 15, 2006
RAPIDONE-COCAINE-150 TEST
K053422
American Bio Medica Corp.
Toxicology · 189d
Cleared May 05, 2006
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST
K053035
Acro Biotech, LLC
Toxicology · 190d
Cleared Mar 29, 2006
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
K050945
Lin-Zhi International, Inc.
Chemistry · 349d
Cleared Nov 18, 2005
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
K051578
Immunalysis Corporation
Toxicology · 157d
Cleared Aug 04, 2005
IMMUNALYSIS COCAINE ELISA FOR HAIR
K050465
Immunalysis Corporation
Chemistry · 154d
Cleared Apr 18, 2005
ONTRAK TESTCARD 9
K050321
Varian, Inc.
Toxicology · 68d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
K033866
Lin-Zhi International, Inc.
Toxicology · 117d
Cleared Mar 05, 2004
LABONE COCAINE METABOLITE MICRO-PLATE EIA
K040198
Labone, Inc.
Toxicology · 36d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
K032903
ACON Laboratories, Inc.
Toxicology · 153d
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713
Dade Behring, Inc.
Toxicology · 75d
Cleared Dec 23, 2003
RANDOX EVIDENCE
K030360
Randox Laboratories, Ltd.
Chemistry · 323d
Cleared Sep 29, 2003
AML HAIRCHECK-DT (COCAINE)
K023626
Quest Diagnostics, Inc.
Toxicology · 335d
Cleared Aug 21, 2003
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
K032057
Branan Medical Corp.
Toxicology · 50d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512
Dade Behring, Inc.
Toxicology · 70d
Cleared Apr 28, 2003
COZART EIA COCAINE ORAL FLIUD KIT
K030234
Cozart Bioscience , Ltd.
Toxicology · 95d
Cleared Dec 16, 2002
QUICKTOX MULTIPLE DRUG DIPCARD
K023489
Branan Medical Corp.
Toxicology · 60d
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281
Roche Diagnostics Corp.
Toxicology · 66d
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN COCAINE TEST
K022954
Amedica Biotech, Inc.
Toxicology · 62d