# K220908: Ensol EnTM Specimen Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Ensol Biosciences, Inc.
- Decided: Aug 29, 2024 after 884 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 6.

## Indications for use
The Ensol EnTM Collection and Transport System is intended for the collection and transportation of clinical samples containing upper respiratory viruses including Influenza A, Human Coronavirus 229E, and Respiratory Syncytial Virus (RSV) from the collection site to the testing laboratory to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.

Source page: https://510kreport.com/device/K220908
Methodology: https://510kreport.com/methodology