# QDJ: Direct-To-Consumer Access Pharmacogenetic Assessment System

- Device class: 2; regulation: 21 CFR 862.3364; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 119 days (middle half 119–119)
- 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
- 2020: 1
- 2022: 1

## Most-cited predicates
- K193492: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (2020), cited by 1
- DEN180028: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (2018), cited by 1

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