510(k) · Cleared
ClearedOVA1 Next Generation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vermillion, Inc. · ONX Ovarian Adnexal Mass Assessment Score Test System
Cleared on Mar 18, 2016 as substantially equivalent to DEN090004 (Vermillion, 2009) after a 375-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Mar 18, 2016
- Review
- 375 days
- Class
- Class II
- Product code
- ONX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN090004 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backDEN090004 OVA1 TestVermillion · 2009
- This deviceK150588 OVA1 Next GenerationVermillion, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN090004 | OVA1 Test | Vermillion | 2009 | — |
| 0 (this device) | K150588 | OVA1 Next Generation | Vermillion, Inc. | 2016 | — |
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 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
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 |
|---|---|---|---|
| * | DEN090004 | OVA1 Test Our reading of the summary gave K081754, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN090004, OVA1 Test (Vermillion), granted Sep 11, 2009; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2009 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN090004.
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. 2016, 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 | — |
What is it indicated for?
The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single
numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for
which surgery is planned, and not yet referred to an oncologist.
The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician’s
independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or
stand-alone diagnostic assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150588: OVA1 Next Generation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150588
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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