LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Microbiology · 21 CFR 866.3830 · Class 2
Overview
| Product Code | LIP |
|---|---|
| Device Name | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Regulation | 21 CFR 866.3830 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241427 | Access Syphilis | Beckman Coulter, Inc. | Sep 6, 2024 | SESE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics | Aug 28, 2024 | SESE |
| K211302 | Elecsys Syphilis | Roche Diagnostics | Jul 20, 2021 | SESE |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | Bio-Rad Laboratories | May 11, 2017 | SESE |
| K160910 | Elecsys Syphilis | Roche Diagnostics | Jul 28, 2016 | SESE |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics,Inc. | Jul 5, 2016 | SESE |
| K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control | Abbott Laboratories | Jun 15, 2016 | SESE |
| K120439 | BIOPLEX 2200 EBV IGG AND SYPHILIS IGG | Bio-Rad Laboratories, Inc. | Mar 14, 2012 | SESE |
| K112343 | TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS | Siemens Healthcare Diagnostics, Inc. | Jan 20, 2012 | SESE |
| K102400 | SYPHILIS HEALTH CHECK | Diagnostics Direct, LLC | Aug 1, 2011 | SESE |
| K102283 | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM | Zeus Scientific, Inc. | Feb 10, 2011 | SESE |
| K093837 | ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM | Zeus Scientific, Inc. (Zeus) | Oct 1, 2010 | SESE |
| K091361 | IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM | Siemens Healthcare Diagnostics | Dec 16, 2009 | SESE |
| K063866 | BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | Mar 19, 2007 | SESE |
| K050590 | ENZY-WELL SYPHILIS IGG, MODEL 91106 | Diesse Diagnostica Senese S.P.A. | Aug 10, 2006 | SESE |
| K053570 | TREP-SURE TREPONEMAL ANTIBODY EIA | Phoenix Biotech Corp. | Aug 7, 2006 | SESE |
| K061247 | DIASORIN LIAISON TREPONEMA ASSAY | DiaSorin, Inc. | Jul 31, 2006 | SESE |
| K014233 | CAPTIAM SYPHILIS-G ASSAY | Trinity Biotech, Plc | Jan 24, 2002 | SESE |
| K001525 | CAPTIA SYPHILIS-G ELISA TEST SYSTEM | Trinity Biotech, Plc | Nov 29, 2000 | SESE |
| K001552 | TREPCHEK TREPONEMAL ANTIBODY EIA | Phoenix Biotech Corp. | Oct 19, 2000 | SESE |
Top Applicants
- Mercia Diagnostics , Ltd. — 4 clearances
- Bio-Rad Laboratories — 2 clearances
- DiaSorin, Inc. — 2 clearances
- Diagnostic Chemicals, Ltd. (Usa) — 2 clearances
- Ortho Diagnostic Systems, Inc. — 2 clearances
