# SET: Immunoassay Blood Test For Amyloid Pathology Assessment

- Device class: 2; regulation: 21 CFR 866.5840; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 170 days (middle half 130–209)
- 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)
- 2025: 2
- 2026: 2

## Most-cited predicates
- K242706: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (2025), cited by 1

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