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 27, 2000
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988
Syva Co.
Toxicology · 64d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9073
K994219
Phamatech
Toxicology · 15d
Cleared Dec 27, 1999
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
K993485
Sun Biomedical Laboratories, Inc.
Chemistry · 74d
Cleared Sep 20, 1999
QUICKPAC II ONE STEP COCAINE TEST
K992990
Syntron Bioresearch, Inc.
Toxicology · 13d
Cleared Sep 02, 1999
DRUGCHECK X MULTIDRUG SCREENING DEVICE
K992748
Syntron Bioresearch, Inc.
Toxicology · 17d
Cleared Jul 26, 1999
REDI-TEST COCAINE
K991110
Redwood Biotech, Inc.
Toxicology · 116d
Cleared Jul 22, 1999
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
K992207
Syntron Bioresearch, Inc.
Toxicology · 22d
Cleared Jul 15, 1999
RAPIDONE - COCAINE TEST
K990822
American Bio Medica Corp.
Toxicology · 126d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Nov 20, 1998
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
K982759
OraSure Technologies, Inc.
Toxicology · 106d
Cleared Nov 18, 1998
DBEST COCAINE TEST KIT
K983191
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
ONTRAK TESTCUP-ER
K983388
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Aug 25, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
K982061
OraSure Technologies, Inc.
Toxicology · 82d
Cleared May 29, 1998
MICRO-STRIP FOR COCAINE METABOLITES
K981388
Microdiagnostics, Inc.
Toxicology · 43d
Cleared Apr 24, 1998
MECTEST
K973986
Meco Industries
Toxicology · 186d
Cleared Mar 27, 1998
DRUG CHECK
K980153
Texas Immunology, Inc.
Toxicology · 70d
Cleared Mar 20, 1998
RAPID DRUG SCREEN' 8 PANEL
K980872
American Bio Medica Corp.
Toxicology · 14d
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