510(k) · Cleared
Recalled · Class II · 2026Immulite 2000 Syphilis Screen Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Dec 16, 2009 as substantially equivalent to K061247 (DiaSorin, Inc., 2006) after a 222-day review. Its family tree reaches back 2 generations to 2002. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 16, 2009
- Review
- 222 days
- Class
- Class II
- Product code
- LIP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K014233 (2002). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK014233 Captiam Syphilis-G AssayTrinity Biotech, Plc · 2002
- 1 generation backK061247 Diasorin Liaison Treponema AssayDiaSorin, Inc. · 2006
- This deviceK091361 Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 2 of its ownK160910 Elecsys SyphilisRoche Diagnostics · 2016
- Descendant · 2 generations on · 1 of its ownK211302 Elecsys SyphilisRoche Diagnostics · 2021
- Descendant · cites it directly · 1 of its ownK112343 Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK241534 VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics · 2024
- Descendant · 2 generations on · 0 of its ownK153145 Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K160910Elecsys SyphilisRoche Diagnostics · 2016 · cites it directly2descendants
- K211302Elecsys SyphilisRoche Diagnostics · 2021 · 2 generations on1descendant
- K112343Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. · 2012 · cites it directly1descendant
- K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics · 2024 · 2 generations on0descendants
- K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014233 | Captiam Syphilis-G Assay | Trinity Biotech, Plc | 2002 | — |
| −1 | K061247 | Diasorin Liaison Treponema Assay | DiaSorin, Inc. | 2006 | — |
| 0 (this device) | K091361 | Immulite 2000 Syphilis Screen Test System | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K160910 | Elecsys Syphilis | Roche Diagnostics | 2016 | — |
| +2 | K211302 | Elecsys Syphilis | Roche Diagnostics | 2021 | — |
| +1 | K112343 | Treponema Pallidum Treponemal Test Reagents; Quality Control Materials | Siemens Healthcare Diagnostics, Inc. | 2012 | 2 |
| +2 | K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | Ortho Clinical Diagnostics | 2024 | — |
| +2 | K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics,Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 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
- #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 |
|---|---|---|---|
| * | K061247 | Diasorin Liaison Treponema AssaySummary page 1…Common Name: Inimunoassay for 7Treponeia pallidumn 21 CFR 866.3830 Substantial Equivalence: K(061247 fliaSorin LIASION® Treponemna Assay Device Description: Th… | 2006 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2026 | Class II | Z-2966-2026 | Under Investigation by firm | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. |
| Jul 13, 2026 | Class II | Z-2965-2026 | Under Investigation by firm | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K160910 (Roche Diagnostics, 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K061247.
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. 2009, 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?
The IMMAULITE® 2000 Syphilis Screen test is a treponemnal testing procedure for the qualitative detection of antibodies to Treponerna pallidum in human serum or heparinized plasma on the IMMULITE 2000 analyzer as an aid in the diagnosis of syphilis.
The IMMULITE 20000 Syphilis Screen is not intended for use in screening blood or plasma donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091361 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091361: Immulite 2000 Syphilis Screen Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091361
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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