# K231843: ARX Viral Transport Media Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Arx Sciences, Inc.
- Decided: Mar 19, 2024 after 271 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 4.

## Indications for use
ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culture-based media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.

Source page: https://510kreport.com/device/K231843
Methodology: https://510kreport.com/methodology