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

LIP — Predicate Candidate Screening

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

137 daysmedian FDA review time

441 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241427	Access Syphilis	Beckman Coulter, Inc.	2024-09-06	109	0
K241534	VITROS Immunodiagnostic Products Syphilis Reagent Pack	Ortho Clinical Diagnostics	2024-08-28	90	0
K211302	Elecsys Syphilis	Roche Diagnostics	2021-07-20	82	0
K170413	BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Tot	Bio-Rad Laboratories	2017-05-11	90	0
K160910	Elecsys Syphilis	Roche Diagnostics	2016-07-28	118	0
K153145	Lumipulse G TP-N Immunoreaction Cartridge Set	Fujirebio Diagnostics,Inc.	2016-07-05	249	0
K153730	ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibra	Abbott Laboratories	2016-06-15	170	0
K120439	BIOPLEX 2200 EBV IGG AND SYPHILIS IGG	Bio-Rad Laboratories, Inc.	2012-03-14	30	0
K112343	TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL	Siemens Healthcare Diagnostics, Inc.	2012-01-20	158	1
K102400	SYPHILIS HEALTH CHECK	Diagnostics Direct, LLC	2011-08-01	342	0
K102283	ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM	Zeus Scientific, Inc.	2011-02-10	182	0
K093837	ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM	Zeus Scientific, Inc. (Zeus)	2010-10-01	290	0
K091361	IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM	Siemens Healthcare Diagnostics	2009-12-16	222	2
K063866	BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANAL	Bio-Rad Laboratories	2007-03-19	80	2
K050590	ENZY-WELL SYPHILIS IGG, MODEL 91106	Diesse Diagnostica Senese S.P.A.	2006-08-10	520	0
K053570	TREP-SURE TREPONEMAL ANTIBODY EIA	Phoenix Biotech Corp.	2006-08-07	228	0
K061247	DIASORIN LIAISON TREPONEMA ASSAY	DiaSorin, Inc.	2006-07-31	89	0
K014233	CAPTIAM SYPHILIS-G ASSAY	Trinity Biotech, Plc	2002-01-24	29	0
K001525	CAPTIA SYPHILIS-G ELISA TEST SYSTEM	Trinity Biotech, Plc	2000-11-29	197	0
K001552	TREPCHEK TREPONEMAL ANTIBODY EIA	Phoenix Biotech Corp.	2000-10-19	154	3
K992552	COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY	DiaSorin, Inc.	1999-12-16	139	0
K961317	SYPHILIS IGM HUMAN SERUM CONTROLS	Pyramid Biological Corp.	1996-06-24	80	0
K960493	SYPHILIS IGG HUMAN SERUM CONTROLS	Pyramid Biological Corp.	1996-06-17	137	0
K932453	VISUWELL SYPHILIS ANTIBODY	Biomira Diagnostics, Inc.	1995-07-11	782	0
K910487	VISUWELL SYPHILIS ANTIGEN	Adi Diagnostics, Inc.	1991-06-24	138	0
K895964	DCL SYPHILIS-M CATALOG NO. 600-80	Diagnostic Chemicals, Ltd. (Usa)	1991-01-08	454	0
K904524	CAPTIA(R) SYPHILIS M, MODIFICATION	Mercia Diagnostics , Ltd.	1990-12-26	90	1
K895965	DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70	Diagnostic Chemicals, Ltd. (Usa)	1990-12-26	441	0
K900654	MODIFIED CAPTIA(R) SYPHILIS-M	Mercia Diagnostics , Ltd.	1990-03-08	27	0
K883939	ORTHO* SYPHILIS-G ANTIBODY ELISA TEST	Ortho Diagnostic Systems, Inc.	1988-12-22	94	0
K883938	ORTHO* SYPHILIS-M ANTIBODY ELISA TEST	Ortho Diagnostic Systems, Inc.	1988-12-22	94	0
K881425	CAPTIA(R) SYPHILIS-G	Mercia Diagnostics , Ltd.	1988-08-04	121	0
K871548	CAPTIA(R) SYPHILIS-M	Mercia Diagnostics , Ltd.	1987-08-07	109	0
K850329	CORDIA S4 -TREPONEMA PALLIDUM	Cordis Corp.	1985-07-02	155	0
K820934	SYPHILIS BIO-ENZABEAD KIT	Biometics Laboratory Products	1982-06-10	69	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