# QAZ: Cancer Predisposition Risk Assessment System

- Device class: 2; regulation: 21 CFR 866.6090; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 255 days (middle half 246–263)
- 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)
- 2018: 1
- 2019: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- DEN170046: 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (2018), cited by 3
- K182784: MUTYH-Associated Polyposis (MAP) (2019), cited by 1

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