Atlas FDA

LIP

35 FDA 510(k) clearances · Product code

137 daysmedian time to decision
441 days90th percentile
35clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3830
Medical specialty
Microbiology
Adverse events (MAUDE)
2021: 54 · 2022: 44 · 2023: 66 · 2024: 73 · 2025: 112 · 2026: 69
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Access Syphilis (K241427)Beckman Coulter, Inc.2024-09-06
VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534)Ortho Clinical Diagnostics2024-08-28
Elecsys Syphilis (K211302)Roche Diagnostics2021-07-20
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set (K170413)Bio-Rad Laboratories2017-05-11
Elecsys Syphilis (K160910)Roche Diagnostics2016-07-28
Lumipulse G TP-N Immunoreaction Cartridge Set (K153145)Fujirebio Diagnostics,Inc.2016-07-05
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (K153730)Abbott Laboratories2016-06-15
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (K120439)Bio-Rad Laboratories, Inc.2012-03-14
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (K112343)Siemens Healthcare Diagnostics, Inc.2012-01-20
SYPHILIS HEALTH CHECK (K102400)Diagnostics Direct, LLC2011-08-01
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (K102283)Zeus Scientific, Inc.2011-02-10
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (K093837)Zeus Scientific, Inc. (Zeus)2010-10-01
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM (K091361)Siemens Healthcare Diagnostics2009-12-16
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K063866)Bio-Rad Laboratories2007-03-19
ENZY-WELL SYPHILIS IGG, MODEL 91106 (K050590)Diesse Diagnostica Senese S.P.A.2006-08-10
TREP-SURE TREPONEMAL ANTIBODY EIA (K053570)Phoenix Biotech Corp.2006-08-07
DIASORIN LIAISON TREPONEMA ASSAY (K061247)DiaSorin, Inc.2006-07-31
CAPTIAM SYPHILIS-G ASSAY (K014233)Trinity Biotech, Plc2002-01-24
CAPTIA SYPHILIS-G ELISA TEST SYSTEM (K001525)Trinity Biotech, Plc2000-11-29
TREPCHEK TREPONEMAL ANTIBODY EIA (K001552)Phoenix Biotech Corp.2000-10-19
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY (K992552)DiaSorin, Inc.1999-12-16
SYPHILIS IGM HUMAN SERUM CONTROLS (K961317)Pyramid Biological Corp.1996-06-24
SYPHILIS IGG HUMAN SERUM CONTROLS (K960493)Pyramid Biological Corp.1996-06-17
VISUWELL SYPHILIS ANTIBODY (K932453)Biomira Diagnostics, Inc.1995-07-11
VISUWELL SYPHILIS ANTIGEN (K910487)Adi Diagnostics, Inc.1991-06-24
DCL SYPHILIS-M CATALOG NO. 600-80 (K895964)Diagnostic Chemicals, Ltd. (Usa)1991-01-08
CAPTIA(R) SYPHILIS M, MODIFICATION (K904524)Mercia Diagnostics , Ltd.1990-12-26
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (K895965)Diagnostic Chemicals, Ltd. (Usa)1990-12-26
MODIFIED CAPTIA(R) SYPHILIS-M (K900654)Mercia Diagnostics , Ltd.1990-03-08
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST (K883939)Ortho Diagnostic Systems, Inc.1988-12-22
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST (K883938)Ortho Diagnostic Systems, Inc.1988-12-22
CAPTIA(R) SYPHILIS-G (K881425)Mercia Diagnostics , Ltd.1988-08-04
CAPTIA(R) SYPHILIS-M (K871548)Mercia Diagnostics , Ltd.1987-08-07
CORDIA S4 -TREPONEMA PALLIDUM (K850329)Cordis Corp.1985-07-02
SYPHILIS BIO-ENZABEAD KIT (K820934)Biometics Laboratory Products1982-06-10

Track LIP automatically

Every clearance here is in the API, with alerts when new ones post.