510(k) · Cleared
ClearedLumipulse G TP-N Immunoreaction Cartridge Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Cleared on Jul 5, 2016 as substantially equivalent to K112343 (Siemens Healthcare Diagnostics, Inc., 2012) after a 249-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Jul 5, 2016
- Review
- 249 days
- Class
- Class II
- Product code
- LIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014233 (2002). No later device cites it as a predicate yet.
- 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 backK112343 Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSiemens Healthcare Diagnostics, Inc. · 2012 · Recalled
- This deviceK153145 Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. · 2016
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 | K112343 | Treponema Pallidum Treponemal Test Reagents; Quality Control Materials | Siemens Healthcare Diagnostics, Inc. | 2012 | 2 |
| 0 (this device) | K153145 | Lumipulse G TP-N Immunoreaction Cartridge Set | Fujirebio Diagnostics,Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K112343 | Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsSummary page 6…eservative: sodium azide. J. Substantial Equivalence Information: 1. Predicate device name(s): ADVIA Centaur Syphilis (SYPH) Assay 2. Predicate 510(k) number(s): K112343 Premarket Notification (510(k)) Lumipulse G TP-N 3. Comparison with predicate:… | 2012 |
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 14 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2016, 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?
Lumipulse G TP-N Immunoreaction Cartridges Set
For in vitro diagnostic use.
WARNING: Lumipulse G TP-N is not intended for blood and tissue donor screening. United States federal law restricts this device to sale by or on the order of a physician.
Lumipulse G TP-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the qualitative determination of antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma (sodium citrate, or dipotassium EDTA) on the LUMIPULSE G System. Lumipulse G TP-N can be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153145 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153145: Lumipulse G TP-N Immunoreaction Cartridge Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153145
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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