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
25–48 of 145
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Jun 10, 2002
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC
K014067
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared May 15, 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771
ACON Laboratories, Inc.
Toxicology · 68d
Cleared May 10, 2002
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
K020763
Lin-Zhi International, Inc.
Toxicology · 64d
Cleared Mar 28, 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441
Dade Behring, Inc.
Toxicology · 45d
Cleared Mar 13, 2002
COCAINE
K013004
Abbott Laboratories
Toxicology · 188d
Cleared Jul 09, 2001
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841
ACON Laboratories, Inc.
Toxicology · 110d
Cleared Jun 25, 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239
Teco Diagnostics
Toxicology · 151d
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 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 11, 1998
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Nov 18, 1998
ONTRAK TESTCUP-ER
K983388
Roche Diagnostic Systems, Inc.
Toxicology · 54d
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