# K202531: Azer Scientific Universal Transport Medium

- Pathway: 510(k) (Traditional)
- Applicant: Azer Scientific, Inc.
- Decided: Apr 11, 2024 after 1,318 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 Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens, containing respiratory viruses from the collection site to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed using standard clinical laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.

Source page: https://510kreport.com/device/K202531
Methodology: https://510kreport.com/methodology