Cleared Traditional

ETHYL ALCOHOL ASSAY KIT (K843378) - FDA 510(k) Clearance

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

K843378 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Sep 1984
Decision
17d
Days
Class 2
Risk

K843378 is an FDA 510(k) clearance for the ETHYL ALCOHOL ASSAY KIT. Classified as Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet (product code DMT), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on September 14, 1984 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3040 - the FDA in vitro diagnostics and chemistry 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K843378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date September 14, 1984
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 Chemistry 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 K843378.
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K971506 · Beckman Instruments, Inc. · Jun 1997
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K934273 · Eastman Kodak Company · Mar 1994
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894 · Em Diagnostic Systems, Inc. · Jan 1987
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K810467 · Syva Co. · Mar 1981
EMIT-STM ETHYL ALCOHOL ASSAY
K802621 · Syva Co. · Oct 1980