510(k) Report

510(k) · Cleared

Cleared

HE4 Eia, Model: 404-10 US

K072939510(k) TraditionalCleared Jun 9, 2008236-day reviewClass II21 CFR 866.6010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujirebio Diagnostics,Inc. · OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Cleared on Jun 9, 2008 as substantially equivalent to K042731 (Fujirebio Diagnostics,Inc., 2004) after a 236-day review. Its family tree reaches back 2 generations to 1997. 7 later devices descend from it.

Decided
Jun 9, 2008
Review
236 days
Class
Class II
Product code
OIU
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K964020 (1997). 7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2010: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant clearedK964020 · Axsym CA 125 · Abbott Laboratories · 1997 · recalledK042731 · Architect CA 125 II Assay · Fujirebio Diagnostics,Inc. · 20041995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K042731 · Architect CA 125 II Assay · Fujirebio Diagnostics,Inc. · 2004K964020 · Axsym CA 125 · Abbott Laboratories · 1997 · recalled0
  1. Root · 2 generations backK964020 Axsym CA 125Abbott Laboratories · 1997 · Recalled
  2. 1 generation backK042731 Architect CA 125 II AssayFujirebio Diagnostics,Inc. · 2004
  3. This deviceK072939 HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 2008
  4. Descendant · cites it directly · 4 of its ownK093957 Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls…Fujirebio Diagnostics,Inc. · 2010
  5. Descendant · 2 generations on · 2 of its ownK112624 Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys…Roche Diagnostics · 2012
  6. Descendant · 3 generations on · 1 of its ownK160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor…Roche Diagnostics · 2016
  7. Descendant · 4 generations on · 0 of its ownK250925 ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
  8. Descendant · cites it directly · 0 of its ownK151378 Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsFujirebio Diagnostics,Inc. · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 22011: 12012: 12015: 12016: 12025: 1
2010high 2 (2010) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all
  • K093957Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54…Fujirebio Diagnostics,Inc. · 2010 · cites it directly4descendants
  • K112624Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5Roche Diagnostics · 2012 · 2 generations on2descendants
  • K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics · 2016 · 3 generations on1descendant
  • K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025 · 4 generations on0descendants
  • K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsFujirebio Diagnostics,Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K964020Axsym CA 125Abbott Laboratories19974
−1K042731Architect CA 125 II AssayFujirebio Diagnostics,Inc.2004—
0 (this device)K072939HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc.2008—
+1K093957Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2…Fujirebio Diagnostics,Inc.2010—
+2K112624Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4…Roche Diagnostics2012—
+3K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics2016—
+4K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.2025—
+1K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsFujirebio Diagnostics,Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201110
201210
201510
201610
202510
FIG. 1 — Lineage of K072939, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K042731Architect CA 125 II Assay
Summary page 1
…: 21 CFR 866.6010 Regulatory Class: Class II Product Code: To be determined Predicate Device ABBOTT ARCHITECT CA 125 II Assay (K042731) Device Description The HE4 EIA is a solid-phase, non-competitive immunoassay based upon the direct sandwich technique based on…
Fujirebio Diagnostics,Inc.2004—

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093957Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54…Fujirebio Diagnostics,Inc.20104
K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsFujirebio Diagnostics,Inc.20150
K103676Fujirebio Diagnostics Tumor Marker ControlFujirebio Diagnostics,Inc.20110

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 11 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K093957 (Fujirebio Diagnostics,Inc., 2010) has gone furthest, with 4 descendants of its own.

How does its category compare?

All OIU devices

OIU Test, Epithelial Ovarian Tumor Associated Antigen (He4): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OIU

1in 2015

2008: 12010: 12011: 12012: 12015: 1
2007high 1 (2008) · low 0 (2007)2026

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

2015: 12016: 12019: 12022: 22023: 12024: 12025: 1
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code OIU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20101—00
20111—00
20121—00
20130—00
20140—00
20151—01
20160—01
20170—00
20180—00
20190—01
20200—00
20210—00
20220—02
20230—01
20240—01
20250—01
20260—0—

What is it indicated for?

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 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.

Indications for use as stated in the FDA summary.

More from Fujirebio Diagnostics,Inc.

45 FDA decisions under this applicant name. See the company

  • K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20257 recalls
  • DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
  • K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. · 2020
  • K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020

Recent decisions in OIU

The OIU category page

  • K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsFujirebio Diagnostics,Inc. · 2015
  • K112624Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5Roche Diagnostics · 2012
  • K103676Fujirebio Diagnostics Tumor Marker ControlFujirebio Diagnostics,Inc. · 2011
  • K093957Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 SP54-01,Fujirebio Diagnostics,Inc. · 2010

https://510kreport.com/device/K072939 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072939: HE4 Eia, Model: 404-10 US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072939

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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