# K222771: Sample Preservative Fluid

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Bioer Technology Co., Ltd.
- Decided: Jun 26, 2024 after 651 days
- Product code: QBD (Microbial Nucleic Acid Storage And Stabilization Device)
- Device class: 2
- Regulation: 21 CFR 866.2950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170029 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170029: PrimeStore MTM, Longhorn Vaccines and Diagnostics, LLC (2018) Summary page 4.

## Indications for use
The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K222771
Methodology: https://510kreport.com/methodology