De Novo · Granted
GrantedOVA1 Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vermillion · ONX Ovarian Adnexal Mass Assessment Score Test System
Granted on Sep 11, 2009 as a new device type through De Novo after a 51-day review. 5 later devices descend from it.
- Decided
- Sep 11, 2009
- Review
- 51 days
- Class
- Class II
- Product code
- ONX
- Recalls
- None
5 later devices descend from it, 2 citing it directly.
- This deviceDEN090004 OVA1 TestVermillion · 2009
- Descendant · cites it directly · 3 of its ownK103358 Roma (HE4 Eia + Architect CA 125 II)Fujirebio Diagnostics,Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK153607 ROMA Calculation Tool Using Elecsys AssaysRoche Diagnostics · 2016
- Descendant · 2 generations on · 0 of its ownK160090 Lumipulse G ROMAFujirebio Diagnostics,Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK151502 Architect RomaFujirebio Diagnostics,Inc. · 2016
- Descendant · cites it directly · 0 of its ownK150588 OVA1 Next GenerationVermillion, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K103358Roma (HE4 Eia + Architect CA 125 II)Fujirebio Diagnostics,Inc. · 2011 · cites it directly3descendants
- K153607ROMA Calculation Tool Using Elecsys AssaysRoche Diagnostics · 2016 · 2 generations on0descendants
- K160090Lumipulse G ROMAFujirebio Diagnostics,Inc. · 2016 · 2 generations on0descendants
- K151502Architect RomaFujirebio Diagnostics,Inc. · 2016 · 2 generations on0descendants
- K150588OVA1 Next GenerationVermillion, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN090004 | OVA1 Test | Vermillion | 2009 | — |
| +1 | K103358 | Roma (HE4 Eia + Architect CA 125 II) | Fujirebio Diagnostics,Inc. | 2011 | — |
| +2 | K153607 | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics | 2016 | — |
| +2 | K160090 | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | 2016 | — |
| +2 | K151502 | Architect Roma | Fujirebio Diagnostics,Inc. | 2016 | — |
| +1 | K150588 | OVA1 Next Generation | Vermillion, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 4 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONX? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
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?
- Of its descendants, K103358 (Fujirebio Diagnostics,Inc., 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All ONX devicesONX Ovarian Adnexal Mass Assessment Score Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONX
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · ONX
255in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONX
No recall names ONX since 2007.
Adverse event reports per year · ONX
No MAUDE report names ONX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 255 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN090004 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN090004: OVA1 Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN090004
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026