# K212113: MagXtract Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Magbio Genomics, Inc.
- Decided: Jul 28, 2022 after 386 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: 1 generation back to DEN170029 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170029: PrimeStore MTM, Longhorn Vaccines and Diagnostics, LLC (2018) Summary page 4.

## Most influential descendants
- K233324: Molecular Transport Media - MTM (2024), 0 descendants of its own

## Indications for use
The MagXtract Collection Tube collection tube 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 collection transport and storage of specimens at refrigerated (2-8 0 C) or ambient temperatures (20-25 0 C). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.

Source page: https://510kreport.com/device/K212113
Methodology: https://510kreport.com/methodology