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
49–72 of 145
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 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
Cleared Nov 29, 1991
SYVA EMIT D.A.U. COCAINE METABOLITE
K914973
Syva Co.
Toxicology · 23d
Cleared Jul 27, 1990
EMIT(R) II COCAINE METABOLITE ASSAY
K902579
Syva Co.
Toxicology · 46d
Cleared Mar 23, 1990
MICRO DAU COCAINE METABOLITE TEST KIT
K896781
Immunotech Corp.
Toxicology · 109d
Cleared Mar 06, 1990
HYCOR ACCUPINCH COCAINE TEST
K896937
Hycor Biomedical, Inc.
Toxicology · 83d
Cleared Aug 25, 1989
ADX COCAINE METABOLITE
K890788
Abbott Laboratories
Toxicology · 191d
Cleared Mar 15, 1989
ABUSCREEN FP BUFFER REAGENT
K890883
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 13, 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
K881815
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Jul 12, 1988
EMIT HVA COCAINE METABOLITE ASSAY
K881942
Syva Co.
Toxicology · 64d
Cleared Mar 11, 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009
Abbott Laboratories
Toxicology · 67d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487
Abbott Laboratories
Toxicology · 24d