# K233534: Viral Transport Medium

- Pathway: 510(k) (Traditional)
- Applicant: Hardy Diagnostics
- Decided: Aug 2, 2024 after 273 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
Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics’ VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.

Source page: https://510kreport.com/device/K233534
Methodology: https://510kreport.com/methodology