510(k) · Cleared
ClearedVITROS Immunodiagnostic Products Syphilis Reagent Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Aug 28, 2024 as substantially equivalent to K160910 (Roche Diagnostics, 2016) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Aug 28, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K014233 (2002). No later device cites it as a predicate yet.
- Root · 5 generations backK014233 Captiam Syphilis-G AssayTrinity Biotech, Plc · 2002
- 4 generations backK061247 Diasorin Liaison Treponema AssayDiaSorin, Inc. · 2006
- 3 generations backK091361 Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009 · Recalled
- 2 generations backK160910 Elecsys SyphilisRoche Diagnostics · 2016
- 1 generation backK211302 Elecsys SyphilisRoche Diagnostics · 2021
- This deviceK241534 VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K014233 | Captiam Syphilis-G Assay | Trinity Biotech, Plc | 2002 | — |
| −4 | K061247 | Diasorin Liaison Treponema Assay | DiaSorin, Inc. | 2006 | — |
| −3 | K091361 | Immulite 2000 Syphilis Screen Test System | Siemens Healthcare Diagnostics | 2009 | 2 |
| −2 | K160910 | Elecsys Syphilis | Roche Diagnostics | 2016 | — |
| −1 | K211302 | Elecsys Syphilis | Roche Diagnostics | 2021 | — |
| 0 (this device) | K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics | 2024 | — |
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 K241427 Access Syphilisscore 8.6 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K160910 | Elecsys SyphilisSummary page 5…Predicate Device FDA 510(k) Number Elecsys Syphilis K160910 & K211302 Device Description The VITROS Immunodiagnostic Products Syphilis test is performed using the VITROS Immunodiagnostic Pr… | 2016 |
| * | K211302 | Elecsys SyphilisSummary page 5…Predicate Device FDA 510(k) Number Elecsys Syphilis K160910 & K211302 Device Description The VITROS Immunodiagnostic Products Syphilis test is performed using the VITROS Immunodiagnostic Products Syp… | 2021 |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K160910.
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. 2024, this device’s year, is highlighted.
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?
VITROS Immunodiagnostic Products Syphilis Reagent Pack (VITROS Syphilis test)
For the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP) specific antigens in human serum and plasma using the VITROS 5600 Integrated System.
The presence of antibodies to Treponema pallidum (TP) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of syphilis infection.
The VITROS Syphilis test is not intended for blood and tissue donor screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241534: VITROS Immunodiagnostic Products Syphilis Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241534
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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