# K014233: Captiam Syphilis-G Assay

- Pathway: 510(k) (Special)
- Applicant: Trinity Biotech, Plc
- Decided: Jan 24, 2002 after 29 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
No predicates in its family tree.
10 later devices descend from it; 1 cites 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061247: Diasorin Liaison Treponema Assay (2006), 9 descendants of its own
- 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

## Indications for use
CAPTIA™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to 7. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with 7. pallidum ( the agent of syphilis) CAPTIA™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.

Source page: https://510kreport.com/device/K014233
Methodology: https://510kreport.com/methodology