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
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 Aug 15, 2017
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
K163570
Carolina Liquid Chemistries Corporation
Toxicology · 239d
Cleared Jun 02, 2017
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
K162395
Mp Biomedicals, LLC
Toxicology · 280d
Cleared Nov 18, 2016
Quest Diagnostics HairCheck-DT (Cocaine)
K152232
Quest Diagnostics Incorporated
Toxicology · 469d
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 Mar 18, 2016
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
K153646
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 88d
Cleared Jul 24, 2015
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET
K142129
Biophor Diagnostics, Inc.
Toxicology · 354d
Cleared Jun 29, 2015
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set
K150925
Immunalysis Corporation
Toxicology · 84d
Cleared Oct 07, 2014
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
K142353
W.H.P.M., Inc.
Toxicology · 47d
Cleared Jul 17, 2014
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
K141647
Healgen Scientific, LLC
Chemistry · 28d
Cleared Nov 13, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K131128
Omega Laboratories, Inc.
Toxicology · 204d
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 Feb 01, 2012
QUICKSCREEN COCAINE 150 SCREENING TEST
K103295
Phamatech, Inc.
Toxicology · 450d
Cleared Jan 23, 2012
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K112808
Omega Laboratories, Inc.
Toxicology · 118d
Cleared Dec 05, 2011
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
K113501
Ameditech, Inc.
Toxicology · 10d
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

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.