# K992552: Copalis Treponemal Antigen Total Antibody Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Dec 16, 1999 after 139 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. The FDA summary names its predicate without a number.
- (no number) Zeus Scientific Inc. FTA-ABS: named in the summary without a submission number
- (no number) Fujirebio Inc. Serodia® TP-PA: named in the summary without a submission number

## Indications for use
The Copalis Treponemal Antigen Total Antibody Assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle agglutination-based immunoassay for the qualitative detection of total antibodies (IgG and IgM) to recombinant Treponema pallidum antigens in human serum using the Copalis | Immunoassay System. The presence of antibodies is indicative of current or prior infection with T. pallidum. The assay is indicated as an aid in the serological confirmation of syphilis disease following a positive result with a nontreponemal screening test. This assay has not been FDA cleared or approved for the screening of blood or plasma donors. NOTE: The Copalis Treponemal Antigen Total Antibody Assay has not been evaluated as an initial or single test for the serodiagnosis of syphilis. The predictive value of a positive Copalis Treponemal Antigen Total Antibody Assay result has not been determined with RPR negative specimens.

Source page: https://510kreport.com/device/K992552
Methodology: https://510kreport.com/methodology