Cleared Traditional

ETHYL ALCOHOL ASSAY (K923783) - FDA 510(k) Clearance

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

K923783 · Diagnostic Reagents, Inc. · Toxicology device
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Jan 1993
Decision
177d
Days
Class 2
Risk

K923783 is an FDA 510(k) clearance for the ETHYL ALCOHOL ASSAY. Classified as Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet (product code DMT), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 177 days - an extended review 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: 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K923783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date January 21, 1993
Days to Decision 177 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 87d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
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 - DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

All 7
Devices cleared under the same product code (DMT) and FDA review panel - the closest regulatory comparables to K923783.
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
K000410 · Beckman Coulter, Inc. · Apr 2000
SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
K971506 · Beckman Instruments, Inc. · Jun 1997
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)
K934273 · Eastman Kodak Company · Mar 1994
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894 · Em Diagnostic Systems, Inc. · Jan 1987
EMIT-ST SERUM ETHYL ALCOHOL ASSAY
K810467 · Syva Co. · Mar 1981
EMIT-STM ETHYL ALCOHOL ASSAY
K802621 · Syva Co. · Oct 1980