Product Code: LEG FDA class 2 21 CFR 862.3645

Enzyme Immunoassay, Valproic Acid

Clinical Toxicology

Enzyme immunoassay for valproic acid is a laboratory test system using antibody-based detection to measure serum valproic acid levels in patients with epilepsy or bipolar disorder, supporting therapeutic drug monitoring to ensure effective dosing and minimize adverse effects. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LEG, regulated under 21 CFR 862.3645, in the Clinical Toxicology specialty. Third-party review is available.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LEG
Device Class: FDA class 2
Regulation Number: 862.3645
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K090358	ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35	Aug 06, 2009	Substantially Equivalent	Abbott Laboratories, Inc.
K060690	ONLINE VALPROIC ACID	Aug 08, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K042807	ADVIA IMS VALPROIC ACID METHOD	Feb 08, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K042476	VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS	Dec 01, 2004	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K032049	ROCHE ONLINE TDM VALPROIC ACID	Aug 22, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K031870	SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT	Jul 15, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K030405	QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075	Apr 28, 2003	Substantially Equivalent	Seradyn
K011649	RANDOX VALPROIC ACID	Jan 15, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K011947	EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL	Jul 02, 2001	Substantially Equivalent	Syva Co.
K002551	EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL	Oct 11, 2000	Substantially Equivalent	Dade Behring, Inc.
K000005	IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6	Mar 03, 2000	Substantially Equivalent	Diagnostic Products Corp.
K982880	DIMENSION(R) VALPROIC (VALP) ACID METHOD	Aug 25, 1998	Substantially Equivalent	Dade Behring, Inc.
K973581	ACE VALPROIC ACID REAGENT, AED CALIBRATORS	Nov 12, 1997	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K972132	SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS	Jul 30, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K964442	VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM	Dec 18, 1996	Substantially Equivalent	Bayer Corp.
K961988	VALPROIC ACID EIA TEST	Jul 16, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K961256	SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT	May 15, 1996	Substantially Equivalent	Beckman Instruments, Inc.
K953224	COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID	Oct 30, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K943866	VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS	Nov 10, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K941615	AXSYM VALPROIC ACID	Aug 16, 1994	Substantially Equivalent	Abbott Laboratories
K936208	VALPROIC ACID	Mar 11, 1994	Substantially Equivalent	Seradyn, Inc.
K934061	BIOTRACK VALPROIC ACID TEST CARTRIDGE	Dec 29, 1993	Substantially Equivalent	Biotrack, Inc.
K930734	CEDIA VALPORIC ACID ASSAY	Sep 21, 1993	Substantially Equivalent	Microgenics Corp.
K925003	COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS	Dec 03, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K922844	BECKMAN VALPROIC ACID REAGENT	Oct 26, 1992	Substantially Equivalent	Beckman Instruments, Inc.
K911688	INNOFLUOR(TM) VALPROIC ACID REAGENT SET	Jul 05, 1991	Substantially Equivalent	Intl. Bioclinical, Inc.
K901538	MODIFIED OPUS VALPROIC ACID TEST SYSTEM	Jun 26, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K895569	VALPROIC ACID (FPIA) KIT	Oct 03, 1989	Substantially Equivalent	Tudor Laboratories, Inc.
K891581	COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS	Aug 15, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K862652	EMIT VALPROIC ACID ASSAY	Jul 29, 1986	Substantially Equivalent	Syva Co.
K832719	EMIT AED VALPROIC ACID ASSAY	Oct 04, 1983	Substantially Equivalent	Syva Co.
K830789	AMES TDA VALPROIC ACID TEST	Apr 12, 1983	Substantially Equivalent	Miles Laboratories, Inc.
K822933	SYVA ADVANCE EMIT AED VALPROIC ACID ASSA	Oct 27, 1982	Substantially Equivalent	Syva Co.
K803236	CYBREX VALPROIC ACID	Jan 28, 1981	Substantially Equivalent	Abbott Laboratories
K801207	EMIT VALPROIC ACID ASSAY	Jun 20, 1980	Substantially Equivalent	Syva Co.