Product Code: DIC FDA class 2 21 CFR 862.3040

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Clinical Toxicology

The Alcohol Dehydrogenase Specific Reagent for Ethanol Enzyme Method is a clinical chemistry reagent that uses the alcohol dehydrogenase enzyme reaction to quantify ethanol concentrations in biological samples such as blood, urine, or breath. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3040 within the Clinical Toxicology specialty. The device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: DIC
Device Class: FDA class 2
Regulation Number: 862.3040
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250609	Sober Self-Test	Sep 15, 2025	Substantially Equivalent	Sober Ip, LLC
K181553	Immunalysis Ethyl Alcohol Enzyme Assay	Oct 31, 2018	Substantially Equivalent	Immunalysis Corporation
K121247	ALCO-SCREEN	Mar 22, 2013	Substantially Equivalent	Chematics, Inc.
K121256	ALCO-SCREEN 02	Sep 12, 2012	Substantially Equivalent	Chematics, Inc.
K111005	ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL	Nov 15, 2011	Substantially Equivalent	Medica Corp.
K111206	TECO DIAGNOSTICS SALIVA ALCOHOL TEST	Oct 04, 2011	Substantially Equivalent	Teco Diagnostics
K092273	RANDOX ETHANOL ASSAY	Nov 01, 2010	Substantially Equivalent	Randox Laboratories, Ltd.
K093879	MISSION SALIVA ALCOHOL TEST STRIP	Aug 06, 2010	Substantially Equivalent	ACON Laboratories, Inc.
K071811	ETOH FLEX REAGENT CARTRIDGE (DF22)	Aug 24, 2007	Substantially Equivalent	Dade Behring, Inc.
K070853	DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022	Jun 13, 2007	Substantially Equivalent	Dade Behring, Inc.
K061792	DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI	Jul 18, 2006	Substantially Equivalent	Dade Behring, Inc.
K032461	ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221	Oct 03, 2003	Substantially Equivalent	Lin-Zhi International, Inc.
K023184	ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM	Nov 18, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K010960	EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229	Apr 26, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K001286	ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10	Jun 20, 2000	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K993920	ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17	Jan 18, 2000	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K974002	ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12	Apr 01, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K972725	ALCOHOL REAGENT SET	Sep 25, 1997	Substantially Equivalent	Pointe Scientific, Inc.,
K972011	OPUS ETHANOL	Jul 22, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K955633	ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03	May 24, 1996	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K934275	PARAMAX ALCOHOL REAGENT	Apr 26, 1994	Substantially Equivalent	Baxter Diagnostics, Inc.
K931516	STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY	Jul 19, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K913125	ROCHE REAGENT FOR ETHANOL	Aug 12, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K904302	DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD	Oct 12, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K903235	STATLAB A-350 SALIVA ALCOHOL TEST	Oct 12, 1990	Substantially Equivalent	Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
K903153	EMIT ETHYL ALCOHOL ASSAY	Aug 09, 1990	Substantially Equivalent	Syva Co.
K894001	SALIVA ALCOHOL TEST	Apr 05, 1990	Substantially Equivalent	Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
K890743	AD X(TM) ETHANOL	Aug 25, 1989	Substantially Equivalent	Abbott Laboratories
K881344	ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS	Jan 24, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K871645	TDXR REA(TM) ETHANOL	Jun 11, 1987	Substantially Equivalent	Abbott Laboratories
K854130	DEMAND ETHYL ALCOHOL	Nov 05, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K840826	TDX ETHANOL	Apr 13, 1984	Substantially Equivalent	Abbott Laboratories
K770975	ANTI-CONVULSANT DRUG CONTROL	Jun 08, 1977	Substantially Equivalent	Lederle Laboratories