# QMV: Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

- Device class: 2; regulation: 21 CFR 866.3966; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 118 days (middle half 73–164)
- 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)
- 2020: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K220870: BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (2022), cited by 2
- DEN200043: FilmArray Global Fever Panel (2020), cited by 2

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