510(k) · Cleared
ClearedElecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Cleared on Sep 10, 2012 as substantially equivalent to K093957 (Fujirebio Diagnostics,Inc., 2010) after a 368-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Sep 10, 2012
- Review
- 368 days
- Class
- Class II
- Product code
- OIU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964020 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK964020 Axsym CA 125Abbott Laboratories · 1997 · Recalled
- 3 generations backK042731 Architect CA 125 II AssayFujirebio Diagnostics,Inc. · 2004
- 2 generations backK072939 HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 2008
- 1 generation backK093957 Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls…Fujirebio Diagnostics,Inc. · 2010
- This deviceK112624 Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys…Roche Diagnostics · 2012
- Descendant · cites it directly · 1 of its ownK160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor…Roche Diagnostics · 2016
- Descendant · 2 generations on · 0 of its ownK250925 ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964020 | Axsym CA 125 | Abbott Laboratories | 1997 | 4 |
| −3 | K042731 | Architect CA 125 II Assay | Fujirebio Diagnostics,Inc. | 2004 | — |
| −2 | K072939 | HE4 Eia, Model: 404-10 US | Fujirebio Diagnostics,Inc. | 2008 | — |
| −1 | K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2… | Fujirebio Diagnostics,Inc. | 2010 | — |
| 0 (this device) | K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4… | Roche Diagnostics | 2012 | — |
| +1 | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016 | — |
| +2 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 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 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? (4)
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 |
|---|---|---|---|
| * | K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54… | 2010 |
| * | — | Elecsys hGH CalSet Named without a submission number | |
| * | — | Elecsys PreciControl Multimarker Named without a submission number | |
| * | — | Elecsys DHEA-S CalCheck 5 Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | 2016 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160915 (Roche Diagnostics, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093957.
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. 2012, 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?
The Elecsys HE4 assay is an immunoassay for the quantitative determination of HE4 in human serum and plasma. The assay is used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical findings used for monitoring ovarian cancer. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas…
Read the full statement (158 words)
The Elecsys HE4 assay is an immunoassay for the quantitative determination of HE4 in human serum and plasma. The assay is used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical findings used for monitoring ovarian cancer.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys HE4 CalSet is used for calibrating the quantitative Elecsys HE4 assay on the Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl HE4 is used for quality control of the Elecsys HE4 immunoassay on Elecsys and cobas e immunoassay analyzers.
The Elecsys HE4 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HE4 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For In Vitro Diagnostic Use Only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112624: Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112624
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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