Cleared Traditional

K001286 - ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10

K001286 is an FDA 510(k) clearance for ETHANOL-L3K ASSAY, manufactured by Diagnostic Chemicals , Ltd.. The device is a Class 2 Toxicology device with product code DIC cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K001286 · Diagnostic Chemicals , Ltd. · Toxicology device
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Jun 2000
Decision
60d
Days
Class 2
Risk

K001286 is an FDA 510(k) clearance for the ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10. 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., CA). The FDA issued a Cleared decision on June 20, 2000 after a review of 60 days - a notably fast clearance 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: 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. devices

FDA 510(k) Submission Details - K001286

510(k) Number K001286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2000
Decision Date June 20, 2000
Days to Decision 60 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
27d faster than avg
Panel avg: 87d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIC Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K001286.
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · Lin-Zhi International, Inc. · Oct 2003
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K023184 · Bayer Diagnostics Corp. · Nov 2002
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
K010960 · Syva Co., Dade Behring, Inc. · Apr 2001
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
K993920 · Diagnostic Chemicals , Ltd. · Jan 2000
ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12
K974002 · Diagnostic Chemicals , Ltd. · Apr 1998
ALCOHOL REAGENT SET
K972725 · Pointe Scientific, Inc., · Sep 1997