Cleared Special

K011947 - EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL

K011947 is an FDA 510(k) clearance for EMIT 2000 VALPROIC ACID ASSAY, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code LEG cleared through the Special 510(k) pathway after a 11-day FDA review.

K011947 · Syva Co. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
11d
Days
Class 2
Risk

K011947 is an FDA 510(k) clearance for the EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011947

510(k) Number K011947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date July 02, 2001
Days to Decision 11 days
Submission Type Special
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
76d faster than avg
Panel avg: 87d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 34
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K011947.
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
K031870 · Beckman Coulter, Inc. · Jul 2003
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
K030405 · Seradyn · Apr 2003
RANDOX VALPROIC ACID
K011649 · Randox Laboratories, Ltd. · Jan 2002
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
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · Dade Behring, Inc. · Aug 1998
K011947 · EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
Download PDF FDA Summary Syva Co.