Cleared Traditional

K953224 - COBAS FP REAGENT APPLICATION FOR FREE V...

K953224 is the FDA 510(k) clearance for COBAS FP REAGENT APPLICATION FOR FREE V... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LEG) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K953224 · Roche Diagnostic Systems, Inc. · Toxicology device
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Oct 1995
Decision
139d
Days
Class 2
Risk

K953224 is an FDA 510(k) clearance for the COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 139 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K953224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1995
Decision Date October 30, 1995
Days to Decision 139 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 87d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K953224.
VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964442 · Bayer Corp. · Dec 1996
VALPROIC ACID EIA TEST
K961988 · Diagnostic Reagents, Inc. · Jul 1996
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
K961256 · Beckman Instruments, Inc. · May 1996
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
K943866 · Sigma Diagnostics, Inc. · Nov 1994
AXSYM VALPROIC ACID
K941615 · Abbott Laboratories · Aug 1994
CEDIA VALPORIC ACID ASSAY
K930734 · Microgenics Corp. · Sep 1993