# K212878: Sample preservation solution

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Gene Science Co., Ltd.
- Decided: Apr 8, 2024 after 942 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: 2 generations back to DEN170029 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201849: eNAT molecular collection and preservation medium, Copan Italia Spa (2020) Summary page 4.

## Indications for use
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 ºC or at room temperature (20-25ºC) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays.

Source page: https://510kreport.com/device/K212878
Methodology: https://510kreport.com/methodology