Cleared Traditional

K890743 - AD X(TM) ETHANOL

K890743 is an FDA 510(k) clearance for AD X(TM) ETHANOL, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code DIC cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K890743 · Abbott Laboratories · Chemistry device
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Aug 1989
Decision
193d
Days
Class 2
Risk

K890743 is an FDA 510(k) clearance for the AD X(TM) ETHANOL. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 193 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3040 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K890743

510(k) Number K890743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date August 25, 1989
Days to Decision 193 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 88d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIC Device Classification - Class 2, Special Controls

Product Code DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

All 25
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K890743.
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc. · Aug 1991
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
K904302 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
EMIT ETHYL ALCOHOL ASSAY
K903153 · Syva Co. · Aug 1990
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1989
TDXR REA(TM) ETHANOL
K871645 · Abbott Laboratories · Jun 1987
TDX ETHANOL
K840826 · Abbott Laboratories · Apr 1984