Cleared Traditional

K881344 - ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST...

K881344 is the FDA 510(k) clearance for ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code DIC) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K881344 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Jan 1989
Decision
300d
Days
Class 2
Risk

K881344 is an FDA 510(k) clearance for the ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3040 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K881344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1988
Decision Date January 24, 1989
Days to Decision 300 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 87d · This submission: 300d
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 Toxicology devices follow this clearance model.

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

All 23
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K881344.
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
AD X(TM) ETHANOL
K890743 · Abbott Laboratories · Aug 1989
TDXR REA(TM) ETHANOL
K871645 · Abbott Laboratories · Jun 1987
TDX ETHANOL
K840826 · Abbott Laboratories · Apr 1984