# QBD: Microbial Nucleic Acid Storage And Stabilization Device

- Device class: 2; regulation: 21 CFR 866.2950; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 330 days (middle half 228–422)
- Recalls: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2020: 2
- 2021: 1
- 2022: 2
- 2023: 5
- 2024: 5
- 2025: 1

## Most-cited predicates
- K202641: DNA/RNA Shield Collection Tube (2020), cited by 6
- DEN170029: PrimeStore MTM (2018), cited by 6
- K201849: eNAT molecular collection and preservation medium (2020), cited by 2
- K212113: MagXtract Collection Tube (2022), cited by 1
- K223497: Spectrum Saliva Collection Device (2023), cited by 1

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