# K001552: Trepchek Treponemal Antibody Eia

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Biotech Corp.
- Decided: Oct 19, 2000 after 154 days
- Product code: LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## 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
- K102400: Syphilis Health Check (2011), 0 descendants of its own

## Recalls of this device
- Mar 16, 2005 · Not classified · Z-0784-05: Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
- Dec 9, 2003 · Not classified · Z-0513-04: The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
- Sep 11, 2003 · Not classified · Z-0325-05: Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to 

Source page: https://510kreport.com/device/K001552
Methodology: https://510kreport.com/methodology