Cleared Traditional

ON.SITE ALCOHOL (K963197) - FDA 510(k) Clearance

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

K963197 · Ansys, Inc. · Toxicology device
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Sep 1996
Decision
35d
Days
Class 2
Risk

K963197 is an FDA 510(k) clearance for the ON.SITE ALCOHOL. Classified as Nad-nadh, Specific Reagent For Alcohol Enzyme Method (product code DML), Class II - Special Controls.

Submitted by Ansys, Inc. (Irvine, US). The FDA issued a Cleared decision on September 19, 1996 after a review of 35 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 Ansys, Inc. devices

Submission Details

510(k) Number K963197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1996
Decision Date September 19, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DML Nad-nadh, Specific Reagent For Alcohol 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 - DML Nad-nadh, Specific Reagent For Alcohol Enzyme Method

All 12
Devices cleared under the same product code (DML) and FDA review panel - the closest regulatory comparables to K963197.
ETHANOL
K013538 · Abbott Laboratories · Dec 2001
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980 · Syva Co. · Feb 2000
AXSYM REA ETHANOL
K953765 · Abbott Laboratories · Sep 1995
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
K952839 · Boehringer Mannheim Corp. · Aug 1995
EMDS(TM) ALCOHOL TESTPACKS, #67691/95
K863419 · Em Diagnostic Systems, Inc. · Sep 1986
EMIT ST SERUM ETHYL ALCOHOL ASSAY
K840400 · Syva Co. · Mar 1984