# QGN: Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

- Device class: 2; regulation: 21 CFR 866.3230; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 27 days (middle half 27–27)
- 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)
- 2019: 1
- 2021: 1

## Most-cited predicates
- DEN180032: Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit (2019), cited by 2

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