Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LEG — Predicate Candidate Screening

35 FDA 510(k) clearances under this product code; the 50 most recent screened below.

60 daysmedian FDA review time

148 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K090358	ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC AC	Abbott Laboratories, Inc.	2009-08-06	175	0
K060690	ONLINE VALPROIC ACID	Roche Diagnostics Corp.	2006-08-08	146	1
K042807	ADVIA IMS VALPROIC ACID METHOD	Bayer Healthcare, LLC	2005-02-08	119	0
K042476	VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PROD	Ortho-Clinical Diagnostics, Inc.	2004-12-01	79	2
K032049	ROCHE ONLINE TDM VALPROIC ACID	Roche Diagnostics Corp.	2003-08-22	51	0
K031870	SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT	Beckman Coulter, Inc.	2003-07-15	28	0
K030405	QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075	Seradyn	2003-04-28	81	0
K011649	RANDOX VALPROIC ACID	Randox Laboratories, Ltd.	2002-01-15	231	0
K011947	EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL	Syva Co.	2001-07-02	11	0
K002551	EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIB	Dade Behring, Inc.	2000-10-11	55	0
K000005	IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG	Diagnostic Products Corp.	2000-03-03	60	0
K982880	DIMENSION(R) VALPROIC (VALP) ACID METHOD	Dade Behring, Inc.	1998-08-25	11	0
K973581	ACE VALPROIC ACID REAGENT, AED CALIBRATORS	Schiapparelli Biosystems, Inc.	1997-11-12	51	0
K972132	SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAG	Sigma Diagnostics, Inc.	1997-07-30	54	0
K964442	VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM	Bayer Corp.	1996-12-18	42	0
K961988	VALPROIC ACID EIA TEST	Diagnostic Reagents, Inc.	1996-07-16	56	0
K961256	SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT	Beckman Instruments, Inc.	1996-05-15	44	0
K953224	COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID	Roche Diagnostic Systems, Inc.	1995-10-30	139	0
K943866	VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS	Sigma Diagnostics, Inc.	1994-11-10	94	0
K941615	AXSYM VALPROIC ACID	Abbott Laboratories	1994-08-16	134	0
K936208	VALPROIC ACID	Seradyn, Inc.	1994-03-11	72	0
K934061	BIOTRACK VALPROIC ACID TEST CARTRIDGE	Biotrack, Inc.	1993-12-29	132	0
K930734	CEDIA VALPORIC ACID ASSAY	Microgenics Corp.	1993-09-21	222	0
K925003	COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS	Roche Diagnostic Systems, Inc.	1992-12-03	62	0
K922844	BECKMAN VALPROIC ACID REAGENT	Beckman Instruments, Inc.	1992-10-26	136	0
K911688	INNOFLUOR(TM) VALPROIC ACID REAGENT SET	Intl. Bioclinical, Inc.	1991-07-05	80	0
K901538	MODIFIED OPUS VALPROIC ACID TEST SYSTEM	Pb Diagnostic Systems, Inc.	1990-06-26	85	0
K895569	VALPROIC ACID (FPIA) KIT	Tudor Laboratories, Inc.	1989-10-03	27	0
K891581	COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS	Roche Diagnostic Systems, Inc.	1989-08-15	148	0
K862652	EMIT VALPROIC ACID ASSAY	Syva Co.	1986-07-29	18	0
K832719	EMIT AED VALPROIC ACID ASSAY	Syva Co.	1983-10-04	53	0
K830789	AMES TDA VALPROIC ACID TEST	Miles Laboratories, Inc.	1983-04-12	29	0
K822933	SYVA ADVANCE EMIT AED VALPROIC ACID ASSA	Syva Co.	1982-10-27	23	0
K803236	CYBREX VALPROIC ACID	Abbott Laboratories	1981-01-28	36	0
K801207	EMIT VALPROIC ACID ASSAY	Syva Co.	1980-06-20	32	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda