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 Roche Diagnostic Systems, Inc., Syva Co. and Princeton BioMeditech Corp..

145
Total
145
Cleared
117d
Avg days
1984
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Enzyme Immunoassay, Cocaine And Cocaine Metabolites Devices (Product Code DIO)

145 devices
1–24 of 145
Cleared Jan 27, 2022
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
K213211
Carolina Liquid Chemistries Corp.
Toxicology · 120d
Cleared Sep 24, 2021
DRI Cocaine Metabolite Assay
K211973
Microgenics Corporation
Toxicology · 91d
Cleared Mar 12, 2020
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638
Medtest DX
Toxicology · 267d
Cleared Jul 06, 2018
DRI Cocaine Metabolite Assay
K181499
Microgenics Corporation
Toxicology · 29d
Cleared Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
K170293
Siemens Healthcare Diagnostics, Inc.
Toxicology · 267d
Cleared Jun 27, 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
K161214
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 59d
Cleared Jun 29, 2015
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
K150925
Immunalysis Corporation
Toxicology · 84d
Cleared Jul 31, 2013
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
K131754
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 47d
Cleared May 08, 2012
RANDOX COCAINE METABOLITE
K113751
Randox Laboratories, Ltd.
Chemistry · 139d
Cleared May 08, 2012
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
K121166
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Nov 22, 2011
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
K113139
Lin-Zhi International, Inc.
Chemistry · 29d
Cleared Sep 23, 2011
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
K112071
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 65d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742
Microgenics Corp.
Toxicology · 290d
Cleared Feb 11, 2011
ROCHE ORAL FLUID COCAINE
K101160
Roche Diagnostics
Chemistry · 291d
Cleared Nov 16, 2006
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K062123
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d
Cleared Mar 29, 2006
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
K050945
Lin-Zhi International, Inc.
Chemistry · 349d
Cleared Nov 18, 2005
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
K051578
Immunalysis Corporation
Toxicology · 157d
Cleared Aug 04, 2005
IMMUNALYSIS COCAINE ELISA FOR HAIR
K050465
Immunalysis Corporation
Chemistry · 154d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
K033866
Lin-Zhi International, Inc.
Toxicology · 117d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
K032903
ACON Laboratories, Inc.
Toxicology · 153d
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713
Dade Behring, Inc.
Toxicology · 75d
Cleared Dec 23, 2003
RANDOX EVIDENCE
K030360
Randox Laboratories, Ltd.
Chemistry · 323d
Cleared Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512
Dade Behring, Inc.
Toxicology · 70d
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281
Roche Diagnostics Corp.
Toxicology · 66d

About Product Code DIO - Regulatory Context

510(k) Submission Activity

145 total 510(k) submissions under product code DIO since 1984, with 145 receiving FDA clearance (average review time: 117 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.