# DEN170029: PrimeStore MTM

- Pathway: De Novo (Direct)
- Applicant: Longhorn Vaccines and Diagnostics, LLC
- Decided: Mar 19, 2018 after 299 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
No predicates in its family tree.
16 later devices descend from it; 6 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K202641: DNA/RNA Shield Collection Tube (2020), 7 descendants of its own
- K201849: eNAT molecular collection and preservation medium (2020), 2 descendants of its own
- K223497: Spectrum Saliva Collection Device (2023), 1 descendant of its own
- K212113: MagXtract Collection Tube (2022), 1 descendant of its own
- K242820: Puritan PurSafe Plus Collection and Transport System (2025), 0 descendants of its own

## Indications for use
PrimeStore MTM is intended for the stabilization, transportation and inactivation of infectious unprocessed nasal washes suspected of containing Influenza A virus RNA. PrimeStore MTM is also intended for the stabilization, transportation and inactivation of infectious unprocessed sputum samples suspected of containing Mycobacterium tuberculosis DNA from human samples.

Source page: https://510kreport.com/device/DEN170029
Methodology: https://510kreport.com/methodology