Cleared Traditional

K032049 - ROCHE ONLINE TDM VALPROIC ACID

K032049 is the FDA 510(k) clearance for ROCHE ONLINE TDM VALPROIC ACID by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code LEG) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K032049 · Roche Diagnostics Corp. · Toxicology device
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Aug 2003
Decision
51d
Days
Class 2
Risk

K032049 is an FDA 510(k) clearance for the ROCHE ONLINE TDM VALPROIC ACID. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 51 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 Diagnostics Corp. devices

Submission Details

510(k) Number K032049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2003
Decision Date August 22, 2003
Days to Decision 51 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
36d faster than avg
Panel avg: 87d · This submission: 51d
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 25
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K032049.
ONLINE VALPROIC ACID
K060690 · Roche Diagnostics Corp. · Aug 2006
VITROS CHEMISTRY PRODUCTS VALP REAGENT
K042476 · Ortho-Clinical Diagnostics, Inc. · Dec 2004
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · Beckman Coulter, Inc. · Jul 2003
RANDOX VALPROIC ACID
K011649 · Randox Laboratories, Ltd. · Jan 2002
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · Syva Co. · Jul 2001
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
K002551 · Dade Behring, Inc. · Oct 2000