# K042970: Copan Universal Transport Medium (Utm-RT) System

- Pathway: 510(k) (Traditional)
- Applicant: Copan Diagnostics, Inc.
- Decided: Dec 7, 2004 after 40 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: 1 generation back to K910526 (1991). 1 ancestor in all.
24 later devices descend from it; 14 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910526: Microtest Multi Microbe Medium, Microtest (1991) Summary page 1.

## Most influential descendants
- K142045: Xpert Flu/RSV XC Assay (2014), 5 descendants of its own
- K151226: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (2015), 4 descendants of its own
- K113249: Transport Culture Medium Device (2012), 4 descendants of its own
- K212856: iClean Viral Transport System (VTM-RT kit) (2022), 2 descendants of its own
- K201674: Cultura Collection and Transport System (2021), 2 descendants of its own

## Indications for use
Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimens 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.

Source page: https://510kreport.com/device/K042970
Methodology: https://510kreport.com/methodology