# K061247: Diasorin Liaison Treponema Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jul 31, 2006 after 89 days
- Product code: LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K014233 (2002). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014233: Captiam Syphilis-G Assay, Trinity Biotech, Plc (2002) Summary page 1.

## Most influential descendants
- K091361: Immulite 2000 Syphilis Screen Test System (2009), 5 descendants of its own
- K160910: Elecsys Syphilis (2016), 2 descendants of its own
- K211302: Elecsys Syphilis (2021), 1 descendant of its own
- K153730: ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control (2016), 1 descendant of its own
- K112343: Treponema Pallidum Treponemal Test Reagents; Quality Control Materials (2012), 1 descendant of its own

## Indications for use
The LIAISON® Treponema Assay and the LIAISON® Treponema Serum Controls uses chemiluminescence immunoassay (CLIA) technology for the qualitative detection of total antibodies of any class (IgG/IgM) directed against Treponema pallidum in human serum. The presence of antibodies to Treponema pallidum specific antigen, in conjunction with nontreponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. The LIAISON® Treponema Assay is not intended for use in the screening of blood or plasma donors.

Source page: https://510kreport.com/device/K061247
Methodology: https://510kreport.com/methodology