Cleared Traditional

K854130 - DEMAND ETHYL ALCOHOL

K854130 is an FDA 510(k) clearance for DEMAND ETHYL ALCOHOL, manufactured by Cooper Biomedical, Inc.. The device is a Class 2 Chemistry device with product code DIC cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K854130 · Cooper Biomedical, Inc. · Chemistry device
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Nov 1985
Decision
27d
Days
Class 2
Risk

K854130 is an FDA 510(k) clearance for the DEMAND ETHYL ALCOHOL. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Cooper Biomedical, Inc. (Malvern, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 27 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.

FDA 510(k) Submission Details - K854130

510(k) Number K854130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1985
Decision Date November 05, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 89d · This submission: 27d
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 Chemistry 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 K854130.
AD X(TM) ETHANOL
K890743 · Abbott Laboratories · Aug 1989
ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS
K881344 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1989
TDXR REA(TM) ETHANOL
K871645 · Abbott Laboratories · Jun 1987
TDX ETHANOL
K840826 · Abbott Laboratories · Apr 1984
ANTI-CONVULSANT DRUG CONTROL
K770975 · Lederle Laboratories · Jun 1977
K854130 · DEMAND ETHYL ALCOHOL
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