# K971502: Serodia TP-PA

- Pathway: 510(k) (Traditional)
- Applicant: Scimedx Tekfile Services
- Decided: Nov 13, 1997 after 203 days
- Product code: GMT (Antigens, Ha, 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K063866: Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System (2007), 1 descendant of its own
- K120439: Bioplex 2200 Ebv Igg and Syphilis Igg (2012), 0 descendants of its own

## Indications for use
Serodia-TP-PA is a qualitative gelatin particle agglutination assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis.- This product is not cleared or approved by the U.S. Food and Drug Administration (FDA) for use in screening blood orptasma donors.

Source page: https://510kreport.com/device/K971502
Methodology: https://510kreport.com/methodology