Cleared Traditional

K974002 - ETHANOL-SL ASSAY

K974002 is the FDA 510(k) clearance for ETHANOL-SL ASSAY by Diagnostic Chemicals , Ltd.. It is a Class 2 Toxicology device (product code DIC) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K974002 · Diagnostic Chemicals , Ltd. · Toxicology device
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Apr 1998
Decision
162d
Days
Class 2
Risk

K974002 is an FDA 510(k) clearance for the ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12. 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 April 1, 1998 after a review of 162 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 K974002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1997
Decision Date April 01, 1998
Days to Decision 162 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
75d slower than avg
Panel avg: 87d · This submission: 162d
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 K974002.
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · Lin-Zhi International, Inc. · Oct 2003
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
K001286 · Diagnostic Chemicals , Ltd. · Jun 2000
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
K993920 · Diagnostic Chemicals , Ltd. · Jan 2000
ALCOHOL REAGENT SET
K972725 · Pointe Scientific, Inc., · Sep 1997
OPUS ETHANOL
K972011 · Behring Diagnostics, Inc. · Jul 1997
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
K955633 · Diagnostic Chemicals , Ltd. · May 1996