510(k) · Cleared
ClearedElecsys Syphilis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Jul 20, 2021 as substantially equivalent to K160910 (Roche Diagnostics, 2016) after an 82-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Jul 20, 2021
- Review
- 82 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014233 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK014233 Captiam Syphilis-G AssayTrinity Biotech, Plc · 2002
- 3 generations backK061247 Diasorin Liaison Treponema AssayDiaSorin, Inc. · 2006
- 2 generations backK091361 Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009 · Recalled
- 1 generation backK160910 Elecsys SyphilisRoche Diagnostics · 2016
- This deviceK211302 Elecsys SyphilisRoche Diagnostics · 2021
- Descendant · cites it directly · 0 of its ownK241534 VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics · 2024
Most influential descendants
Showing 1 of 1 · See all- K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014233 | Captiam Syphilis-G Assay | Trinity Biotech, Plc | 2002 | — |
| −3 | K061247 | Diasorin Liaison Treponema Assay | DiaSorin, Inc. | 2006 | — |
| −2 | K091361 | Immulite 2000 Syphilis Screen Test System | Siemens Healthcare Diagnostics | 2009 | 2 |
| −1 | K160910 | Elecsys Syphilis | Roche Diagnostics | 2016 | — |
| 0 (this device) | K211302 | Elecsys Syphilis | Roche Diagnostics | 2021 | — |
| +1 | K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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
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 |
|---|---|---|---|
| * | K160910 | Elecsys SyphilisSummary page 4…eponema pallidum treponemal test reagent Product Codes, Product Code: LIP; 21CFR866.3830 Regulation Numbers Predicate Devices Elecsys Syphilis (K160910) Roche Diagnostics GmbH Mannheim, Germany: 9610126 Establishment Roche Diagnostics GmbH Penzberg, G… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | 2024 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K241534 (Ortho Clinical Diagnostics, 2024) has gone furthest, with 0 descendants of its own.
- 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. 2021, 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?
Immunoassay for the in vitro qualitative detection of total antibodies (lgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection in conjunction with clinical signs and symptoms.
The Elecsys Syphilis immunoassay is not intended for use in screening blood or tissue donors. The effectiveness of this assay in testing blood or tissue donors has not been established.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211302: Elecsys Syphilis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211302
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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