510(k) · Cleared
ClearedCaptiam Syphilis-G Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trinity Biotech, Plc · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Jan 24, 2002 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Jan 24, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK014233 Captiam Syphilis-G AssayTrinity Biotech, Plc · 2002
- Descendant · cites it directly · 9 of its ownK061247 Diasorin Liaison Treponema AssayDiaSorin, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK091361 Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK160910 Elecsys SyphilisRoche Diagnostics · 2016
- Descendant · 4 generations on · 1 of its ownK211302 Elecsys SyphilisRoche Diagnostics · 2021
- Descendant · 2 generations on · 1 of its ownK153730 ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator…Abbott Laboratories · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K061247Diasorin Liaison Treponema AssayDiaSorin, Inc. · 2006 · cites it directly9descendants
- K091361Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009 · 2 generations on5descendants
- K160910Elecsys SyphilisRoche Diagnostics · 2016 · 3 generations on2descendants
- K211302Elecsys SyphilisRoche Diagnostics · 2021 · 4 generations on1descendant
- K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…Abbott Laboratories · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014233 | Captiam Syphilis-G Assay | Trinity Biotech, Plc | 2002 | — |
| +1 | K061247 | Diasorin Liaison Treponema Assay | DiaSorin, Inc. | 2006 | — |
| +2 | K091361 | Immulite 2000 Syphilis Screen Test System | Siemens Healthcare Diagnostics | 2009 | 2 |
| +3 | K160910 | Elecsys Syphilis | Roche Diagnostics | 2016 | — |
| +4 | K211302 | Elecsys Syphilis | Roche Diagnostics | 2021 | — |
| +2 | K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT… | Abbott Laboratories | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061247 | Diasorin Liaison Treponema Assay | 2006 | 9 |
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?
- Of its descendants, K061247 (DiaSorin, Inc., 2006) has gone furthest, with 9 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?
CAPTIA™ Syphilis (T. pallidum )-G is an enzyme immunoassay for the qualitative detection of IgG antibodies to 7. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with 7. pallidum ( the agent of syphilis)
CAPTIA™ Syphilis (T. pallidum )-G is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014233 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014233: Captiam Syphilis-G Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014233
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026