# K091361: Immulite 2000 Syphilis Screen Test System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Dec 16, 2009 after 222 days
- Product code: LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K014233 (2002). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061247: Diasorin Liaison Treponema Assay, DiaSorin, Inc. (2006) Summary page 1.

## Most influential descendants
- K160910: Elecsys Syphilis (2016), 2 descendants of its own
- K211302: Elecsys Syphilis (2021), 1 descendant of its own
- K112343: Treponema Pallidum Treponemal Test Reagents; Quality Control Materials (2012), 1 descendant of its own
- K241534: VITROS Immunodiagnostic Products Syphilis Reagent Pack (2024), 0 descendants of its own
- K153145: Lumipulse G TP-N Immunoreaction Cartridge Set (2016), 0 descendants of its own

## Recalls of this device
- Jul 13, 2026 · Class II · Z-2966-2026: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
- Jul 13, 2026 · Class II · Z-2965-2026: Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

## Indications for use
The IMMAULITE® 2000 Syphilis Screen test is a treponemnal testing procedure for the qualitative detection of antibodies to Treponerna pallidum in human serum or heparinized plasma on the IMMULITE 2000 analyzer as an aid in the diagnosis of syphilis. The IMMULITE 20000 Syphilis Screen is not intended for use in screening blood or plasma donors.

Source page: https://510kreport.com/device/K091361
Methodology: https://510kreport.com/methodology