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 Apr 11, 2001
AT WORK DRUG TEST, MODEL 9177T AWT
K010833
Phamatech
Toxicology · 22d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650
Phamatech
Toxicology · 25d
Cleared Aug 14, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
K994403
Alfa Scientific Designs, Inc.
Toxicology · 230d
Cleared Jul 27, 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398
Alfa Scientific Designs, Inc.
Toxicology · 212d
Cleared May 11, 2000
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
K001197
OraSure Technologies, Inc.
Toxicology · 30d
Cleared Apr 14, 2000
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
K994165
Roche Diagnostics Corp.
Toxicology · 120d
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