510(k) · Cleared
ClearedCopalis Treponemal Antigen Total Antibody Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Dec 16, 1999 after a 139-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 16, 1999
- Review
- 139 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LIP device
- #1 K241534 VITROS Immunodiagnostic Products Syphilis…score 9.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Zeus Scientific Inc. FTA-ABS Named without a submission number | |
| * | — | Fujirebio Inc. Serodia® TP-PA Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LIP devicesLIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIP
170in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIP
112in 2025
MAUDE reports naming product code LIP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 4 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 3 | 170 | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 46 |
| 2021 | 1 | — | 2 | 54 |
| 2022 | 0 | — | 2 | 44 |
| 2023 | 0 | — | 0 | 66 |
| 2024 | 2 | — | 0 | 73 |
| 2025 | 0 | — | 0 | 112 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (141 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992552: Copalis Treponemal Antigen Total Antibody Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992552
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026