# QPS: Immunoassay For Host Biomarkers Of Infection

- Device class: 2; regulation: 21 CFR 866.3215; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 213 days (middle half 179–220)
- 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)
- 2021: 1
- 2022: 1
- 2023: 2
- 2026: 1

## Most-cited predicates
- K210254: MeMed BV (2021), cited by 2
- K222332: MeMed BV (2023), cited by 1

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