Cleared Traditional

K904302 - DUPONT DIMENSION ETHYL ALCOHOL(ALC) METHOD

K904302 is the FDA 510(k) clearance for DUPONT DIMENSION ETHYL ALCOHOL(ALC) METHOD 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 23-day FDA review.

K904302 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Oct 1990
Decision
23d
Days
Class 2
Risk

K904302 is an FDA 510(k) clearance for the DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD. 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 October 12, 1990 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

Submission Details

510(k) Number K904302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date October 12, 1990
Days to Decision 23 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
64d faster than avg
Panel avg: 87d · This submission: 23d
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 K904302.
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
K955633 · Diagnostic Chemicals , Ltd. · May 1996
PARAMAX ALCOHOL REAGENT
K934275 · Baxter Diagnostics, Inc. · Apr 1994
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc. · Aug 1991
EMIT ETHYL ALCOHOL ASSAY
K903153 · Syva Co. · Aug 1990
AD X(TM) ETHANOL
K890743 · Abbott Laboratories · Aug 1989
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1989