# K112343: Treponema Pallidum Treponemal Test Reagents; Quality Control Materials

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 20, 2012 after 158 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: 3 generations back to K014233 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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 1.

## Most influential descendants
- K153145: Lumipulse G TP-N Immunoreaction Cartridge Set (2016), 0 descendants of its own

## Recalls of this device
- Apr 21, 2021 · Class II · Z-1674-2021: Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syp
- Jul 17, 2012 · Class II · Z-2228-2012: Syphilis Assay Interference with HBsAg Assay

## Indications for use
The ADVIA Centaur Syphilis (SYPH) assay is an in-vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur® and ADVIA Centaur® XP systems as an aid in the diagnosis of syphilis. The ADVIA Centaur Syphilis assay is not intended for blood and tissue donor screening. ADVIA® Centaur Syphilis Quality Control Materials are for in-vitro diagnostic use to monitor the performance of the Syphilis assay on the ADVIA Centaur® systems. The performance of the SYPH quality control material has not been established with any other Syphilis assay.

Source page: https://510kreport.com/device/K112343
Methodology: https://510kreport.com/methodology