# K242576: AllTest Viral Transport Medium

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AllTest Biotech Co., Ltd.
- Decided: Apr 4, 2025 after 218 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: 4 generations back to K910526 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201674: Cultura Collection and Transport System, Merit Medical Systems, Inc. (2021) Summary page 5.

## Indications for use
AllTest Viral Transport Medium (VTM) is intended for collection and transport of clinical specimens containing viral agents including Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from collection site to the testing laboratory. Specimens collected in the AllTest VTM can be processed using standard clinical laboratory operating procedure for viral culture. The AllTest Viral Transport Medium is also intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing SARS-CoV-2 nucleic acid. The AllTest VTM is suitable for use with compatible legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K242576
Methodology: https://510kreport.com/methodology