# K233324: Molecular Transport Media - MTM

- Pathway: 510(k) (Traditional)
- Applicant: Alb Luz
- Decided: Jun 17, 2024 after 262 days
- Product code: QBD (Microbial Nucleic Acid Storage And Stabilization Device)
- Device class: 2
- Regulation: 21 CFR 866.2950
- 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 DEN170029 (2018). 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)
- K212113: MagXtract Collection Tube, Magbio Genomics, Inc. (2022) Summary page 5.

## Indications for use
The Molecular Transport Media - MTM is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K233324
Methodology: https://510kreport.com/methodology