Cleared Traditional

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 (K955633) - FDA 510(k) Clearance

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

K955633 · Diagnostic Chemicals , Ltd. · Toxicology device
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May 1996
Decision
165d
Days
Class 2
Risk

K955633 is an FDA 510(k) clearance for the ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on May 24, 1996 after a review of 165 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 Chemicals , Ltd. devices

Submission Details

510(k) Number K955633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date May 24, 1996
Days to Decision 165 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
78d slower than avg
Panel avg: 87d · This submission: 165d
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 32
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K955633.
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K071811 · Dade Behring, Inc. · Aug 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · Dade Behring, Inc. · Jun 2007
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
K061792 · Dade Behring, Inc. · Jul 2006
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc. · Aug 1991