# QQV: Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry

- Device class: 2; regulation: 21 CFR 866.3378; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 574 days (middle half 317–790)
- 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: 2
- 2023: 2

## Most-cited predicates
- K223245: Colibrí (2023), cited by 1
- K191964: BD Kiestra IdentifA (2021), cited by 1

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