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 Abbott Laboratories.

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 Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713
Dade Behring, Inc.
Toxicology · 75d
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
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296
Roche Diagnostics Corp.
Toxicology · 54d
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 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 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 Mar 06, 1996
FRONTLINE COCAINE
K954496
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Aug 02, 1995
AXSYM COCAINE METABOLITE
K951289
Abbott Laboratories
Toxicology · 134d
Cleared Feb 22, 1995
EMIT IIC COCAINE METABOLITE ASSAY
K935323
Syva Co.
Toxicology · 475d
Cleared Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231
Roche Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Nov 30, 1994
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS
K944087
Beckman Instruments, Inc.
Toxicology · 148d

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.