# K053570: Trep-Sure Treponemal Antibody Eia

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Biotech Corp.
- Decided: Aug 7, 2006 after 228 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
TREP-SURE EIA is a qualitative enzyme immunoassay for the in vitro diagnostic detection of Treponema palfidum (syphilis) antibodies in human serum or plasma. This product can be used as an initial screening test or as a confirmatory diagnostic test, but is not cleared (approved) by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.

Source page: https://510kreport.com/device/K053570
Methodology: https://510kreport.com/methodology