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
73–96 of 145
Cleared Jan 02, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA
K973651
OraSure Technologies, Inc.
Toxicology · 99d
Cleared Aug 28, 1997
QUIKPAC II ONE STEP COCAINE TEST
K972059
Drial Consultants, Inc.
Toxicology · 87d
Cleared Aug 06, 1997
AQ ONE STEP COCAINE TEST
K972384
Bionike Laboratories, Inc.
Toxicology · 41d
Cleared Jul 14, 1997
QUIKSTRIP ONE STEP COCAINE TEST
K971926
Drial Consultants, Inc.
Toxicology · 48d
Cleared Apr 14, 1997
RAPID DRUG SCREEN
K964900
American Bio Medica Corp.
Toxicology · 138d
Cleared Apr 08, 1997
IMMULITE COCAINE METABOLITE
K963918
Diagnostic Products Corp.
Toxicology · 190d
Cleared Aug 19, 1996
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
K962353
Princeton BioMeditech Corp.
Toxicology · 62d
Cleared Apr 02, 1996
COCAINE METABOLITE EIA TEST
K960187
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Mar 06, 1996
FRONTLINE COCAINE
K954496
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Nov 03, 1995
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
K954571
Princeton BioMeditech Corp.
Toxicology · 32d
Cleared Oct 26, 1995
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.
Toxicology · 346d
Cleared Oct 26, 1995
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC
K952361
Princeton BioMeditech Corp.
Toxicology · 171d
Cleared Aug 02, 1995
AXSYM COCAINE METABOLITE
K951289
Abbott Laboratories
Toxicology · 134d
Cleared Mar 21, 1995
VISUALINE II COCAINE
K950369
Sun Biomedical Laboratories, Inc.
Toxicology · 49d
Cleared Feb 22, 1995
EMIT IIC COCAINE METABOLITE ASSAY
K935323
Syva Co.
Toxicology · 475d
Cleared Feb 22, 1995
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC
K945609
Princeton BioMeditech Corp.
Toxicology · 99d
Cleared Jan 17, 1995
CEDIA DAU COCAINE ASSAY
K945345
Microgenics Corp.
Toxicology · 77d
Cleared Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231
Roche Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Nov 30, 1994
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS
K944087
Beckman Instruments, Inc.
Toxicology · 148d
Cleared Jun 02, 1994
CEDIA DAU COCAINE ASSAY
K941310
Microgenics Corp.
Toxicology · 80d
Cleared Mar 11, 1994
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS
K935904
Microgenics Corp.
Toxicology · 91d
Cleared Dec 03, 1993
COCAINE METABOLITE EIA ASSAY MODIFICATION
K935016
Diagnostic Reagents, Inc.
Chemistry · 46d
Cleared Aug 30, 1993
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
K933053
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Dec 18, 1991
COCAINE METABOLITE EIA TEST
K915371
Diagnostic Reagents, Inc.
Toxicology · 21d