# K150588: OVA1 Next Generation

- Pathway: 510(k) (Traditional)
- Applicant: Vermillion, Inc.
- Decided: Mar 18, 2016 after 375 days
- Product code: ONX (Ovarian Adnexal Mass Assessment Score Test System)
- Device class: 2
- Regulation: 21 CFR 866.6050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN090004 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN090004: OVA1 Test, Vermillion (2009). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K150588
Methodology: https://510kreport.com/methodology