Cleared Traditional

K903153 - EMIT ETHYL ALCOHOL ASSAY

K903153 is the FDA 510(k) clearance for EMIT ETHYL ALCOHOL ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DIC) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K903153 · Syva Co. · Toxicology device
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Aug 1990
Decision
22d
Days
Class 2
Risk

K903153 is an FDA 510(k) clearance for the EMIT ETHYL ALCOHOL ASSAY. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 22 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 Syva Co. devices

Submission Details

510(k) Number K903153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date August 09, 1990
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
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 K903153.
PARAMAX ALCOHOL REAGENT
K934275 · Baxter Diagnostics, Inc. · Apr 1994
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
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
TDXR REA(TM) ETHANOL
K871645 · Abbott Laboratories · Jun 1987