# K211256: Disposable Sampler Viral Transport Media

- Pathway: 510(k) (Traditional)
- Applicant: Wuxi Nest Biotechnology Co., Ltd.
- Decided: May 20, 2022 after 389 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- 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 K910526 (1991). 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)
- K042970: Copan Universal Transport Medium (Utm-RT) System, Copan Diagnostics, Inc. (2004) Summary page 4.

## Indications for use
The NEST Disposable Sampler (Viral Transport Medium) is intended for the collection and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques. The Viral Transport Medium can be used in the laboratory to perform culture, isolation and detection of upper respiratory viruses including Influenza A, Rhinovirus, and Respiratory Syncytial Virus (RSV).

Source page: https://510kreport.com/device/K211256
Methodology: https://510kreport.com/methodology