Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: LEG FDA class 2

Enzyme Immunoassay, Valproic Acid

Clinical Toxicology

View full classification →

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.

510(k) Clearances

35 matches

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.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump