# K160910: Elecsys Syphilis

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 28, 2016 after 118 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: 3 generations back to K014233 (2002). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091361: Immulite 2000 Syphilis Screen Test System, Siemens Healthcare Diagnostics (2009) Summary page 4.

## Most influential descendants
- K211302: Elecsys Syphilis (2021), 1 descendant of its own
- K241534: VITROS Immunodiagnostic Products Syphilis Reagent Pack (2024), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection in conjunction with clinical signs and symptoms. The Elecsys Syphilis immunoassay is not intended for use in screening blood or tissue donors. The effectiveness of this assay in testing blood or tissue donors has not been established. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 411 analyzer. PreciControl Syphilis is intended for the quality control of the Elecsys Syphilis immunoassay on the cobas e 411 analyzer.

Source page: https://510kreport.com/device/K160910
Methodology: https://510kreport.com/methodology