Cleared Traditional

K972011 - OPUS ETHANOL

K972011 is the FDA 510(k) clearance for OPUS ETHANOL by Behring Diagnostics, Inc.. It is a Class 2 Toxicology device (product code DIC) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K972011 · Behring Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
53d
Days
Class 2
Risk

K972011 is an FDA 510(k) clearance for the OPUS ETHANOL. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 22, 1997 after a review of 53 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K972011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1997
Decision Date July 22, 1997
Days to Decision 53 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 87d · This submission: 53d
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 K972011.
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
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
K955633 · Diagnostic Chemicals , Ltd. · May 1996
PARAMAX ALCOHOL REAGENT
K934275 · Baxter Diagnostics, Inc. · Apr 1994
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc. · Aug 1991