# K232357: Copan Universal Transport Medium (UTM-RT) System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Italia Spa
- Decided: Apr 25, 2024 after 262 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 4.

## Indications for use
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture. UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays.

Source page: https://510kreport.com/device/K232357
Methodology: https://510kreport.com/methodology