Cleared Traditional

K894001 - SALIVA ALCOHOL TEST

K894001 is an FDA 510(k) clearance for SALIVA ALCOHOL TEST, manufactured by Enzymatics C/O Burditt,Bowles,Radzius & Ruberry. The device is a Class 2 Chemistry device with product code DIC cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K894001 · Enzymatics C/O Burditt,Bowles,Radzius & Ruberry · Chemistry device
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Apr 1990
Decision
304d
Days
Class 2
Risk

K894001 is an FDA 510(k) clearance for the SALIVA ALCOHOL TEST. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Enzymatics C/O Burditt,Bowles,Radzius & Ruberry (Horsham, US). The FDA issued a Cleared decision on April 5, 1990 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Enzymatics C/O Burditt,Bowles,Radzius & Ruberry devices

FDA 510(k) Submission Details - K894001

510(k) Number K894001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1989
Decision Date April 05, 1990
Days to Decision 304 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 88d · This submission: 304d
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 30
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K894001.
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc. · Aug 1991
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
K904302 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
EMIT ETHYL ALCOHOL ASSAY
K903153 · Syva Co. · Aug 1990
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