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
97–120 of 145
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 Sep 25, 1995
MECTEST
K945207
Meco Industries
Toxicology · 335d
Cleared Aug 17, 1995
ONE STEP URINE DRUG OF ABUSE COCAINE TEST
K951892
Tcpi, Inc.
Toxicology · 115d
Cleared Aug 02, 1995
AXSYM COCAINE METABOLITE
K951289
Abbott Laboratories
Toxicology · 134d
Cleared Jul 14, 1995
STC COCAINE METABOLITE EIA
K934775
Solarcare, Inc.
Toxicology · 647d
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 Nov 17, 1994
VERDICT COCAINE
K943710
Editek, Inc.
Chemistry · 108d
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 Apr 27, 1993
USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100
K930985
U.S. Drug Testing, Inc.
Toxicology · 61d
Cleared Jun 15, 1992
AUTOMATES COMA COCAINE METABOLITE ASSAY
K921834
Serex, Inc.
Toxicology · 60d
Cleared Dec 18, 1991
COCAINE METABOLITE EIA TEST
K915371
Diagnostic Reagents, Inc.
Toxicology · 21d
Cleared Dec 10, 1991
MICRO EIA FOR COCAINE METABOLITES
K914533
Microdiagnostics, Inc.
Toxicology · 60d