Cleared Special

SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (K031870) - FDA 510(k) Clearance

Class II Toxicology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031870 · Beckman Coulter, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
28d
Days
Class 2
Risk

K031870 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT. Classified as Enzyme Immunoassay, Valproic Acid (product code LEG), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on July 15, 2003 after a review of 28 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.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K031870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2003
Decision Date July 15, 2003
Days to Decision 28 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
59d faster than avg
Panel avg: 87d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 34
Devices cleared under the same product code (LEG) and FDA review panel - the closest regulatory comparables to K031870.
ONLINE VALPROIC ACID
K060690 · Roche Diagnostics Corp. · Aug 2006
ROCHE ONLINE TDM VALPROIC ACID
K032049 · Roche Diagnostics Corp. · Aug 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
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · Dade Behring, Inc. · Aug 1998