# K102400: Syphilis Health Check

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostics Direct, LLC
- Decided: Aug 1, 2011 after 342 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
Longest line of descent: 1 generation back to K001552 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001552: Trepchek Treponemal Antibody Eia, Phoenix Biotech Corp. (2000) Summary page 1.

## Indications for use
Syphilis Health Check is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood, serum or plasma. This product can be used as an initial screening test or in conjunction with a non-treponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. This test is not intended for use in screening blood or plasma donors.

Source page: https://510kreport.com/device/K102400
Methodology: https://510kreport.com/methodology