510(k) · Cleared
ClearedArchitect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 SP54-01,
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 Mar 18, 2010 as substantially equivalent to K072939 (Fujirebio Diagnostics,Inc., 2008) after an 85-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Mar 18, 2010
- Review
- 85 days
- Class
- Class II
- Product code
- OIU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K964020 (1997). 4 later devices descend from it, 2 citing it directly.
- 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 deviceK093957 Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls…Fujirebio Diagnostics,Inc. · 2010
- Descendant · cites it directly · 2 of its ownK112624 Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys…Roche Diagnostics · 2012
- Descendant · 2 generations on · 1 of its ownK160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor…Roche Diagnostics · 2016
- Descendant · 3 generations on · 0 of its ownK250925 ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
- Descendant · cites it directly · 0 of its ownK101809 Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K112624Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5Roche Diagnostics · 2012 · cites it directly2descendants
- K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics · 2016 · 2 generations on1descendant
- K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025 · 3 generations on0descendants
- K101809Fujirebio Diagnostics Tumor Marker Control Model 108-20Fujirebio Diagnostics,Inc. · 2010 · cites it directly0descendants
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) | K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2… | Fujirebio Diagnostics,Inc. | 2010 | — |
| +1 | K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4… | Roche Diagnostics | 2012 | — |
| +2 | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016 | — |
| +3 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025 | — |
| +1 | K101809 | Fujirebio Diagnostics Tumor Marker Control Model 108-20 | Fujirebio Diagnostics,Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (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 4…edicate Device) (Proposed Device) K072939 Instrument System ARCHITECT i System Manual Chemilumi… | 2008 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K112624 (Roche Diagnostics, 2012) has gone furthest, with 2 descendants of its own.
- 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. 2010, 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 ARCHITECT HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of HE4 antigen in human serum. 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 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. The ARCHITECT HE4 Calibrators are for the…
Read the full statement (118 words)
The ARCHITECT HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of HE4 antigen in human serum.
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 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The ARCHITECT HE4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
The ARCHITECT HE4 Controls are used for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093957 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093957: Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 SP54-01,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093957
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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