# OYX: Bcr/Abl1 Monitoring Test

- Device class: 2; regulation: 21 CFR 866.6060; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 434 days (middle half 434–434)
- Recalls: 2 (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)
- 2016: 1
- 2017: 1
- 2019: 2
- 2023: 1
- 2026: 1

## Most-cited predicates
- DEN160003: Quantidex qPCR BCR-ABL IS Kit (2016), cited by 2
- K181661: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (2019), cited by 2

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