# DEN090004: OVA1 Test

- Pathway: De Novo (Post-NSE)
- Applicant: Vermillion
- Decided: Sep 11, 2009 after 51 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K103358: Roma (HE4 Eia + Architect CA 125 II) (2011), 3 descendants of its own
- K153607: ROMA Calculation Tool Using Elecsys Assays (2016), 0 descendants of its own
- K160090: Lumipulse G ROMA (2016), 0 descendants of its own
- K151502: Architect Roma (2016), 0 descendants of its own
- K150588: OVA1 Next Generation (2016), 0 descendants of its own

Source page: https://510kreport.com/device/DEN090004
Methodology: https://510kreport.com/methodology