510(k) · Cleared
ClearedDiasorin Liaison Treponema 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 Jul 31, 2006 as substantially equivalent to K014233 (Trinity Biotech, Plc, 2002) after an 89-day review. Its family tree reaches back 1 generation to 2002. 9 later devices descend from it.
- Decided
- Jul 31, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K014233 (2002). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK014233 Captiam Syphilis-G AssayTrinity Biotech, Plc · 2002
- This deviceK061247 Diasorin Liaison Treponema AssayDiaSorin, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK091361 Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK160910 Elecsys SyphilisRoche Diagnostics · 2016
- Descendant · 3 generations on · 1 of its ownK211302 Elecsys SyphilisRoche Diagnostics · 2021
- Descendant · cites it directly · 1 of its ownK153730 ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator…Abbott Laboratories · 2016
- Descendant · 2 generations on · 1 of its ownK112343 Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. · 2012 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K091361Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009 · cites it directly5descendants
- K160910Elecsys SyphilisRoche Diagnostics · 2016 · 2 generations on2descendants
- K211302Elecsys SyphilisRoche Diagnostics · 2021 · 3 generations on1descendant
- K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…Abbott Laboratories · 2016 · cites it directly1descendant
- K112343Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014233 | Captiam Syphilis-G Assay | Trinity Biotech, Plc | 2002 | — |
| 0 (this device) | K061247 | Diasorin Liaison Treponema Assay | DiaSorin, Inc. | 2006 | — |
| +1 | K091361 | Immulite 2000 Syphilis Screen Test System | Siemens Healthcare Diagnostics | 2009 | 2 |
| +2 | K160910 | Elecsys Syphilis | Roche Diagnostics | 2016 | — |
| +3 | K211302 | Elecsys Syphilis | Roche Diagnostics | 2021 | — |
| +1 | K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT… | Abbott Laboratories | 2016 | — |
| +2 | K112343 | Treponema Pallidum Treponemal Test Reagents; Quality Control Materials | Siemens Healthcare Diagnostics, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
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? (1)
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 |
|---|---|---|---|
| * | K014233 | Captiam Syphilis-G AssaySummary page 1…LIP PREDICATE DEVICES Trinity CAPTIA TM Syphilis (T. Pallidum) G (K014233) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® Treponema assay uses chemiluminescence immunoassay (CLIA) technology for… | 2002 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K091361 (Siemens Healthcare Diagnostics, 2009) has gone furthest, with 5 descendants of its own.
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 LIAISON® Treponema Assay and the LIAISON® Treponema Serum Controls uses chemiluminescence immunoassay (CLIA) technology for the qualitative detection of total antibodies of any class (IgG/IgM) directed against Treponema pallidum in human serum. The presence of antibodies to Treponema pallidum specific antigen, in conjunction with nontreponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. The LIAISON® Treponema Assay is not intended for use in the screening of blood or plasma donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061247 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061247: Diasorin Liaison Treponema Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061247
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026