# K241427: Access Syphilis

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 6, 2024 after 109 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: 3 generations back to K014233 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153730: ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control, Abbott Laboratories (2016) Summary page 6.

## Indications for use
The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibodies to Treponema pallidum in human serum and plasma using the Access Immunoassay Systems. It is intended to be used as an aid in the diagnosis of syphilis or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. The Access Syphilis assay is not intended for blood and tissue donor screening.

Source page: https://510kreport.com/device/K241427
Methodology: https://510kreport.com/methodology