510(k) · Cleared
Recalled · Class II · 2021Treponema Pallidum Treponemal Test Reagents; Quality Control Materials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Jan 20, 2012 as substantially equivalent to K091361 (Siemens Healthcare Diagnostics, 2009) after a 158-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 20, 2012
- Review
- 158 days
- Class
- Class II
- Product code
- LIP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K014233 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK014233 Captiam Syphilis-G AssayTrinity Biotech, Plc · 2002
- 2 generations backK061247 Diasorin Liaison Treponema AssayDiaSorin, Inc. · 2006
- 1 generation backK091361 Immulite 2000 Syphilis Screen Test SystemSiemens Healthcare Diagnostics · 2009 · Recalled
- This deviceK112343 Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK153145 Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K014233 | Captiam Syphilis-G Assay | Trinity Biotech, Plc | 2002 | — |
| −2 | K061247 | Diasorin Liaison Treponema Assay | DiaSorin, Inc. | 2006 | — |
| −1 | K091361 | Immulite 2000 Syphilis Screen Test System | Siemens Healthcare Diagnostics | 2009 | 2 |
| 0 (this device) | K112343 | Treponema Pallidum Treponemal Test Reagents; Quality Control Materials | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| +1 | K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics,Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K091361 | Immulite 2000 Syphilis Screen Test SystemSummary page 1…and calibrators) and ADVIA® Centaur Syphilis Quality Control Materials are substantially equivalent to the IMMULITE 2000 Syphilis Screen Test System cleared under k09 1361 G. Device Description: The ADVIA Centaur syphilis assay is a fully automated, antigen sandwich assay, using direct chemilu… | 2009 |
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 |
|---|---|---|---|
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2021 | Class II | Z-1674-2021 | Device Design | Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur… |
| Jul 17, 2012 | Class II | Z-2228-2012 | Component design/selection | Syphilis Assay Interference with HBsAg Assay |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K153145 (Fujirebio Diagnostics,Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091361.
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. 2012, 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 ADVIA Centaur Syphilis (SYPH) assay is an in-vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized, citrate) using the ADVIA Centaur® and ADVIA Centaur® XP systems as an aid in the diagnosis of syphilis.
The ADVIA Centaur Syphilis assay is not intended for blood and tissue donor screening.
ADVIA® Centaur Syphilis Quality Control Materials are for in-vitro diagnostic use to monitor the performance of the Syphilis assay on the ADVIA Centaur® systems. The performance of the SYPH quality control material has not been established with any other Syphilis assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112343: Treponema Pallidum Treponemal Test Reagents; Quality Control Materials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112343
Report an extraction error
Are you the manufacturer?
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