# OIU: Test, Epithelial Ovarian Tumor Associated Antigen (He4)

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2015: 1

## Most-cited predicates
- K072939: HE4 Eia, Model: 404-10 US (2008), cited by 3
- K093957: Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 SP54-01, (2010), cited by 2
- K112624: Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5 (2012), cited by 1

Source page: https://510kreport.com/product-code/OIU
Data by year (CSV): https://510kreport.com/product-code/OIU.csv