LIP · Class II · 21 CFR 866.3830

FDA Product Code LIP: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

Syphilis serology is a core component of STI screening. FDA product code LIP covers enzyme-linked immunosorbent assay systems for Treponema pallidum antibody detection.

These treponemal immunoassays detect IgG and IgM antibodies specific to Treponema pallidum antigens for the screening and diagnosis of syphilis. Modern EIA-based treponemal tests are increasingly used as first-line syphilis screening tests.

LIP devices are Class II medical devices, regulated under 21 CFR 866.3830 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Mercia Diagnostics , Ltd., Roche Diagnostics and Trinity Biotech, Plc.

35
Total
35
Cleared
182d
Avg days
1982
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Enzyme Linked Immunoabsorption Assay, Treponema Pallidum Devices (Product Code LIP)

35 devices
1–24 of 35
Cleared Sep 06, 2024
Access Syphilis
K241427
Beckman Coulter, Inc.
Microbiology · 109d
Cleared Aug 28, 2024
VITROS Immunodiagnostic Products Syphilis Reagent Pack
K241534
Ortho-Clinical Diagnostics
Microbiology · 90d
Cleared Jul 20, 2021
Elecsys Syphilis
K211302
Roche Diagnostics
Microbiology · 82d
Cleared May 11, 2017
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
K170413
Bio-Rad Laboratories
Microbiology · 90d
Cleared Jul 28, 2016
Elecsys Syphilis
K160910
Roche Diagnostics
Microbiology · 118d
Cleared Jul 05, 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
K153145
Fujirebio Diagnostics,Inc.
Microbiology · 249d
Cleared Jun 15, 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
K153730
Abbott Laboratories
Microbiology · 170d
Cleared Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439
Bio-Rad Laboratories, Inc.
Microbiology · 30d
Cleared Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343
Siemens Healthcare Diagnostics, Inc.
Microbiology · 158d
Cleared Aug 01, 2011
SYPHILIS HEALTH CHECK
K102400
Diagnostics Direct, LLC
Microbiology · 342d
Cleared Feb 10, 2011
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
K102283
Zeus Scientific, Inc.
Microbiology · 182d
Cleared Oct 01, 2010
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
K093837
Zeus Scientific, Inc. (Zeus)
Microbiology · 290d
Cleared Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361
Siemens Healthcare Diagnostics
Microbiology · 222d
Cleared Mar 19, 2007
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K063866
Bio-Rad Laboratories
Microbiology · 80d
Cleared Aug 10, 2006
ENZY-WELL SYPHILIS IGG, MODEL 91106
K050590
Diesse Diagnostica Senese S.P.A.
Microbiology · 520d
Cleared Aug 07, 2006
TREP-SURE TREPONEMAL ANTIBODY EIA
K053570
Phoenix Biotech Corp.
Microbiology · 228d
Cleared Jul 31, 2006
DIASORIN LIAISON TREPONEMA ASSAY
K061247
DiaSorin, Inc.
Microbiology · 89d
Cleared Jan 24, 2002
CAPTIAM SYPHILIS-G ASSAY
K014233
Trinity Biotech, Plc
Microbiology · 29d
Cleared Nov 29, 2000
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525
Trinity Biotech, Plc
Microbiology · 197d
Cleared Oct 19, 2000
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552
Phoenix Biotech Corp.
Microbiology · 154d
Cleared Dec 16, 1999
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552
DiaSorin, Inc.
Microbiology · 139d
Cleared Jun 24, 1996
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317
Pyramid Biological Corp.
Microbiology · 80d
Cleared Jun 17, 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493
Pyramid Biological Corp.
Microbiology · 137d
Cleared Jul 11, 1995
VISUWELL SYPHILIS ANTIBODY
K932453
Biomira Diagnostics, Inc.
Microbiology · 782d

About Product Code LIP - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code LIP since 1982, with 35 receiving FDA clearance (average review time: 182 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.