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 Jul 30, 2002
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
K022355
Branan Medical Corp.
Toxicology · 11d
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 Oct 22, 2001
AMEDITECH IMMUTEST DRUG SCREEN COC
K011814
Ameditech, Inc.
Toxicology · 133d
Cleared Aug 09, 2001
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962
Advantage Diagnostics Corp.
Toxicology · 48d
Cleared Jul 30, 2001
RADS
K011054
Chason Healthcare, LLC
Toxicology · 115d
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 May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared Apr 17, 2001
LIVESURE COCAINE SCREEN TEST
K010967
Pan Probe Biotech, Inc.
Toxicology · 15d
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 Jan 22, 2001
ADVANTAGE THC/COCAINE TEST
K003708
Advantage Diagnostics Corp.
Toxicology · 52d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
K002264
Branan Medical Corporation
Toxicology · 125d
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 11, 2000
SCREENERS COCAINE TEST
K000350
Drug Detection Devices, Ltd.
Toxicology · 68d
Cleared Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
K994165
Roche Diagnostics Corp.
Toxicology · 120d