510(k) · Cleared
ClearedLUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on May 21, 2015 as substantially equivalent to K020828 (Bayer Corp., 2002) after a 230-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- May 21, 2015
- Review
- 230 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983715 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK983715 The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro…Bayer Corp. · 1999
- 1 generation backK020828 CA 125 Assay for the Advia Centaur SystemBayer Corp. · 2002 · Recalled
- This deviceK142895 LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction…Fujirebio Diagnostics,Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983715 | The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro… | Bayer Corp. | 1999 | — |
| −1 | K020828 | CA 125 Assay for the Advia Centaur System | Bayer Corp. | 2002 | 2 |
| 0 (this device) | K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges… | Fujirebio Diagnostics,Inc. | 2015 | — |
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 LTK? 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 LTK device
- #1 K240479 Access OV Monitorscore 7.3 · 1 generation · 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 |
|---|---|---|---|
| * | K020828 | CA 125 Assay for the Advia Centaur SystemSummary page 7…se G CA 125II and G1200 System J. Substantial Equivalence Information: 1. Predicate device name(s): Siemens ADVIA Centaur CA 125II 2. Predicate 510(k) number(s): k020828 3. Comparison with predicate: Additional Information (AI) request 510(k) k142895 Lumipulse G CA 125II and… | 2002 |
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 16 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K020828.
How does its category compare?
All LTK devicesLTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LTK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LTK
Too few LTK 510(k)s in any year since 2007 to give a median.
Recalls per year · LTK
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTK
4in 2025
MAUDE reports naming product code LTK, 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 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 31 |
| 2010 | 0 | — | 3 | 12 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 0 | — | 1 | 14 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 2 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Lumipulse G CA125II Immunoreaction Cartridges For in vitro diagnostic use. Lumipulse G CA125II is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of CA125 in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with ovarian cancer. Serial testing for patient CA125 assay values…
Read the full statement (156 words)
Lumipulse G CA125II Immunoreaction Cartridges
For in vitro diagnostic use.
Lumipulse G CA125II is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of CA125 in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.
The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with ovarian cancer. Serial testing for patient CA125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
Lumipulse G CA125II Calibrators
Lumipulse G CA125II Calibrators are for use in the calibration of the LUMIPULSE G System for the quantitative measurement of CA125 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA).
LUMIPULSE G1200 System
LUMIPULSE G1200 is intended for in vitro diagnostics use, and is designed to perform automated chemiluminescence immunoassays of specimens using Lumipulse G reagents, conducting various processes such as dispensing, agitation and photometric measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142895 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142895: LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142895
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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