Cleared Traditional

K011649 - RANDOX VALPROIC ACID

K011649 is an FDA 510(k) clearance for RANDOX VALPROIC ACID, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Toxicology device with product code LEG cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K011649 · Randox Laboratories, Ltd. · Toxicology device
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Jan 2002
Decision
231d
Days
Class 2
Risk

K011649 is an FDA 510(k) clearance for the RANDOX VALPROIC ACID. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 15, 2002 after a review of 231 days - an extended review 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: 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K011649

510(k) Number K011649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date January 15, 2002
Days to Decision 231 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
144d slower than avg
Panel avg: 87d · This submission: 231d
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 K011649.
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
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
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
K000005 · Diagnostic Products Corp. · Mar 2000