Cleared Traditional

PARAMAX ALCOHOL REAGENT (K934275) - FDA 510(k) Clearance

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

K934275 · Baxter Diagnostics, Inc. · Toxicology device
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Apr 1994
Decision
238d
Days
Class 2
Risk

K934275 is an FDA 510(k) clearance for the PARAMAX ALCOHOL REAGENT. Classified as Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method (product code DIC), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 238 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K934275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date April 26, 1994
Days to Decision 238 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
151d slower than avg
Panel avg: 87d · This submission: 238d
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 32
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K934275.
Sober Self-Test
K250609 · Sober Ip, LLC · Sep 2025
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · Immunalysis Corporation · Oct 2018
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · Dade Behring, Inc. · Aug 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · Dade Behring, Inc. · Jun 2007
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI
K061792 · Dade Behring, Inc. · Jul 2006
ROCHE REAGENT FOR ETHANOL
K913125 · Roche Diagnostic Systems, Inc. · Aug 1991