Cleared Traditional

K934061 - BIOTRACK VALPROIC ACID TEST CARTRIDGE

K934061 is an FDA 510(k) clearance for BIOTRACK VALPROIC ACID TEST CARTRIDGE, manufactured by Biotrack, Inc.. The device is a Class 2 Toxicology device with product code LEG cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K934061 · Biotrack, Inc. · Toxicology device
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Dec 1993
Decision
132d
Days
Class 2
Risk

K934061 is an FDA 510(k) clearance for the BIOTRACK VALPROIC ACID TEST CARTRIDGE. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 29, 1993 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - 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 Biotrack, Inc. devices

FDA 510(k) Submission Details - K934061

510(k) Number K934061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date December 29, 1993
Days to Decision 132 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 87d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEG Device Classification - Class 2, Special Controls

Product Code LEG Enzyme Immunoassay, Valproic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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 - LEG Enzyme Immunoassay, Valproic Acid

All 30
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K934061.
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
K943866 · Sigma Diagnostics, Inc. · Nov 1994
AXSYM VALPROIC ACID
K941615 · Abbott Laboratories · Aug 1994
VALPROIC ACID
K936208 · Seradyn, Inc. · Mar 1994
CEDIA VALPORIC ACID ASSAY
K930734 · Microgenics Corp. · Sep 1993
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
K925003 · Roche Diagnostic Systems, Inc. · Dec 1992
BECKMAN VALPROIC ACID REAGENT
K922844 · Beckman Instruments, Inc. · Oct 1992