Cleared Traditional

K934275 - PARAMAX ALCOHOL REAGENT

K934275 is an FDA 510(k) clearance for PARAMAX ALCOHOL REAGENT, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DIC cleared through the Traditional 510(k) pathway after a 238-day FDA review.

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

FDA 510(k) Submission Details - K934275

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
Combination Product No
PCCP Authorized No
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.

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 Toxicology devices follow this clearance model.

Regulatory Peers - DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

All 29
Devices cleared under the same product code (DIC) and FDA review panel - the closest regulatory comparables to K934275.
ALCOHOL REAGENT SET
K972725 · Pointe Scientific, Inc., · Sep 1997
OPUS ETHANOL
K972011 · Behring Diagnostics, Inc. · Jul 1997
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
K955633 · Diagnostic Chemicals , Ltd. · May 1996
STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY
K931516 · Solarcare Technologies Corp,Inc. · Jul 1993
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