# QVR: Multiplex Nucleic Acid Detection System For Biothreat Agents

- Device class: 2; regulation: 21 CFR 866.4000; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 328 days (middle half 229–427)
- 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)
- 2023: 2
- 2026: 1

## Most-cited predicates
- K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (2023), cited by 1

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