510(k) · Cleared
ClearedLumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Cleared on Nov 24, 2015 as substantially equivalent to K072939 (Fujirebio Diagnostics,Inc., 2008) after a 186-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Nov 24, 2015
- Review
- 186 days
- Class
- Class II
- Product code
- OIU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964020 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK964020 Axsym CA 125Abbott Laboratories · 1997 · Recalled
- 2 generations backK042731 Architect CA 125 II AssayFujirebio Diagnostics,Inc. · 2004
- 1 generation backK072939 HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 2008
- This deviceK151378 Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsFujirebio Diagnostics,Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964020 | Axsym CA 125 | Abbott Laboratories | 1997 | 4 |
| −2 | K042731 | Architect CA 125 II Assay | Fujirebio Diagnostics,Inc. | 2004 | — |
| −1 | K072939 | HE4 Eia, Model: 404-10 US | Fujirebio Diagnostics,Inc. | 2008 | — |
| 0 (this device) | K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | 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 OIU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K072939 | HE4 Eia, Model: 404-10 USSummary page 6…reservative: Proclin 950. J. Substantial Equivalence Information: 1. Predicate device name(s): Fujirebio Diagnostics, Inc. HE4 EIA 2. Predicate 510(k) number(s): k072939 Premarket Notification (510(k)) Lumipulse G HE4 3. Comparison with predicate:… | 2008 |
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 18 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K072939.
How does its category compare?
All OIU devicesOIU Test, Epithelial Ovarian Tumor Associated Antigen (He4): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OIU
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OIU
Too few OIU 510(k)s in any year since 2007 to give a median.
Recalls per year · OIU
No recall names OIU since 2007.
Adverse event reports per year · OIU
1in 2025
MAUDE reports naming product code OIU, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use.
Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of HE4 in human serum and plasma (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 epithelial ovarian cancer. Serial testing for patient HE4 values should be used in conjunction with other clinical methods used for monitoring epithelial ovarian cancer.
Lumipulse G HE4 Calibrators are for use in the calibration of the Lumipulse G System for the quantitative measurement of HE4 in human serum and plasma (lithium heparin or dipotassium EDTA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151378: Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151378
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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