# LIP: Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

- Device class: 2; regulation: 21 CFR 866.3830; FDA's rule: 510(k) required
- FDA decisions: 35
- 510(k) review time 2021–2025: median 90 days (middle half 86–100)
- Recalls: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 3
- 2007: 1
- 2009: 1
- 2010: 1
- 2011: 2
- 2012: 2
- 2016: 3
- 2017: 1
- 2021: 1
- 2024: 2

## Most-cited predicates
- K061247: Diasorin Liaison Treponema Assay (2006), cited by 3
- K091361: Immulite 2000 Syphilis Screen Test System (2009), cited by 2
- K001552: Trepchek Treponemal Antibody Eia (2000), cited by 2
- K160910: Elecsys Syphilis (2016), cited by 2
- K153730: ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (2016), cited by 1
- K211302: Elecsys Syphilis (2021), cited by 1
- K063866: Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System (2007), cited by 1
- K112343: Treponema Pallidum Treponemal Test Reagents; Quality Control Materials (2012), cited by 1
- K014233: Captiam Syphilis-G Assay (2002), cited by 1

Source page: https://510kreport.com/product-code/LIP
Data by year (CSV): https://510kreport.com/product-code/LIP.csv