# QSE: Alzheimer’S Disease Pathology Assessment Test

- Device class: 2; regulation: 21 CFR 866.5840; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 97 days (middle half 62–131)
- 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)
- 2022: 2
- 2023: 1

## Most-cited predicates
- DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40) (2022), cited by 4
- K221842: Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (2022), cited by 2

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