Cleared Traditional

K923783 - ETHYL ALCOHOL ASSAY

K923783 is an FDA 510(k) clearance for ETHYL ALCOHOL ASSAY, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code DMT cleared through the Traditional 510(k) pathway after a 177-day FDA review.

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

FDA 510(k) Submission Details - K923783

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
Combination Product No
PCCP Authorized No
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.

DMT Device Classification - Class 2, Special Controls

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
ETHYL ALCOHOL ASSAY KIT
K843378 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
EMIT-ST SERUM ETHYL ALCOHOL ASSAY
K810467 · Syva Co. · Mar 1981