# K232454: Viral Transport Media (VTM)

- Pathway: 510(k) (Traditional)
- Applicant: Alb Luz
- Decided: May 3, 2024 after 263 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: 3 generations back to K910526 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212856: iClean Viral Transport System (VTM-RT kit), Huachenyang (Shenzhen) Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.

Source page: https://510kreport.com/device/K232454
Methodology: https://510kreport.com/methodology