DIC · Class II · 21 CFR 862.3040

FDA Product Code DIC: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Leading manufacturers include Dade Behring, Inc., Abbott Laboratories and E.I. Dupont DE Nemours & Co., Inc..

33
Total
33
Cleared
126d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 199d recently vs 124d historically

FDA 510(k) Cleared Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method Devices (Product Code DIC)

33 devices
1–24 of 33
Cleared Sep 15, 2025
Sober Self-Test
K250609
Sober Ip, LLC
Toxicology · 199d
Cleared Oct 31, 2018
Immunalysis Ethyl Alcohol Enzyme Assay
K181553
Immunalysis Corporation
Toxicology · 140d
Cleared Aug 24, 2007
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811
Dade Behring, Inc.
Toxicology · 52d
Cleared Jun 13, 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853
Dade Behring, Inc.
Chemistry · 77d
Cleared Jul 18, 2006
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
K061792
Dade Behring, Inc.
Toxicology · 22d
Cleared Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
K913125
Roche Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 12, 1990
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
K904302
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Aug 09, 1990
EMIT ETHYL ALCOHOL ASSAY
K903153
Syva Co.
Toxicology · 22d
Cleared Aug 25, 1989
AD X(TM) ETHANOL
K890743
Abbott Laboratories
Chemistry · 193d
Cleared Jan 24, 1989
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 300d
Cleared Jun 11, 1987
TDXR REA(TM) ETHANOL
K871645
Abbott Laboratories
Chemistry · 44d
Cleared Apr 13, 1984
TDX ETHANOL
K840826
Abbott Laboratories
Chemistry · 49d

About Product Code DIC - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code DIC since 1977, with 33 receiving FDA clearance (average review time: 126 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DIC Product Code

Recent submissions under DIC have taken an average of 199 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.

DIC devices are reviewed by the Toxicology panel. Browse all Toxicology devices →