Cleared Traditional

AD X(TM) ETHANOL (K890743) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 13
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