Cleared Traditional

K925003 - COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS

K925003 is an FDA 510(k) clearance for COBAS-FP REAGENT FOR VALPROIC ACID AND ..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LEG cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K925003 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1992
Decision
62d
Days
Class 2
Risk

K925003 is an FDA 510(k) clearance for the COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS. 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 December 3, 1992 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K925003

510(k) Number K925003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date December 03, 1992
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
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 K925003.
VALPROIC ACID
K936208 · Seradyn, Inc. · Mar 1994
BIOTRACK VALPROIC ACID TEST CARTRIDGE
K934061 · Biotrack, Inc. · Dec 1993
CEDIA VALPORIC ACID ASSAY
K930734 · Microgenics Corp. · Sep 1993
BECKMAN VALPROIC ACID REAGENT
K922844 · Beckman Instruments, Inc. · Oct 1992
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538 · Pb Diagnostic Systems, Inc. · Jun 1990
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
K891581 · Roche Diagnostic Systems, Inc. · Aug 1989