Cleared Traditional

K060690 - ONLINE VALPROIC ACID

K060690 is the FDA 510(k) clearance for ONLINE 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 146-day FDA review.

K060690 · Roche Diagnostics Corp. · Toxicology device
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Aug 2006
Decision
146d
Days
Class 2
Risk

K060690 is an FDA 510(k) clearance for the ONLINE 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 8, 2006 after a review of 146 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 Diagnostics Corp. devices

Submission Details

510(k) Number K060690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2006
Decision Date August 08, 2006
Days to Decision 146 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
59d slower than avg
Panel avg: 87d · This submission: 146d
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 K060690.
VITROS CHEMISTRY PRODUCTS VALP REAGENT
K042476 · Ortho-Clinical Diagnostics, Inc. · Dec 2004
ROCHE ONLINE TDM VALPROIC ACID
K032049 · Roche Diagnostics Corp. · Aug 2003
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