# K241534: VITROS Immunodiagnostic Products Syphilis Reagent Pack

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Aug 28, 2024 after 90 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: 5 generations back to K014233 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160910: Elecsys Syphilis, Roche Diagnostics (2016) Summary page 5.
- K211302: Elecsys Syphilis, Roche Diagnostics (2021) Summary page 5.

## Indications for use
VITROS Immunodiagnostic Products Syphilis Reagent Pack (VITROS Syphilis test) For the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP) specific antigens in human serum and plasma using the VITROS 5600 Integrated System. The presence of antibodies to Treponema pallidum (TP) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of syphilis infection. The VITROS Syphilis test is not intended for blood and tissue donor screening.

Source page: https://510kreport.com/device/K241534
Methodology: https://510kreport.com/methodology