De Novo · Granted
GrantedPrimeStore MTM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Longhorn Vaccines and Diagnostics, LLC · QBD Microbial Nucleic Acid Storage And Stabilization Device
Granted on Mar 19, 2018 as a new device type through De Novo after a 299-day review. 16 later devices descend from it.
- Decided
- Mar 19, 2018
- Review
- 299 days
- Class
- Class II
- Product code
- QBD
- Recalls
- None
16 later devices descend from it, 6 citing it directly.
- This deviceDEN170029 PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 2018
- Descendant · cites it directly · 7 of its ownK202641 DNA/RNA Shield Collection TubeZymo Research · 2020
- Descendant · cites it directly · 2 of its ownK201849 eNAT molecular collection and preservation mediumCopan Italia Spa · 2020
- Descendant · 2 generations on · 1 of its ownK223497 Spectrum Saliva Collection DeviceSpectrum Solutions, LLC · 2023
- Descendant · cites it directly · 1 of its ownK212113 MagXtract Collection TubeMagbio Genomics, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK242820 Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K202641DNA/RNA Shield Collection TubeZymo Research · 2020 · cites it directly7descendants
- K201849eNAT molecular collection and preservation mediumCopan Italia Spa · 2020 · cites it directly2descendants
- K223497Spectrum Saliva Collection DeviceSpectrum Solutions, LLC · 2023 · 2 generations on1descendant
- K212113MagXtract Collection TubeMagbio Genomics, Inc. · 2022 · cites it directly1descendant
- K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | 2018 | — |
| +1 | K202641 | DNA/RNA Shield Collection Tube | Zymo Research | 2020 | — |
| +1 | K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | 2020 | — |
| +2 | K223497 | Spectrum Saliva Collection Device | Spectrum Solutions, LLC | 2023 | — |
| +1 | K212113 | MagXtract Collection Tube | Magbio Genomics, Inc. | 2022 | — |
| +2 | K242820 | Puritan PurSafe Plus Collection and Transport System | Puritan Medical Products, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QBD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QBD device
- #1 K202641 DNA/RNA Shield Collection Tubescore 18.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202641 | DNA/RNA Shield Collection Tube | 2020 | 7 |
| K201849 | eNAT molecular collection and preservation medium | 2020 | 2 |
| K212113 | MagXtract Collection Tube | 2022 | 1 |
| K222771 | Sample Preservative Fluid | 2024 | 0 |
| K221664 | CLEARinse CTS Specimen Collection and Transport System | 2023 | 0 |
| K210440 | Disposable Sampler Inactivated Transport Media, Nest ITM | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K202641 (Zymo Research, 2020) has gone furthest, with 7 descendants of its own.
How does its category compare?
All QBD devicesQBD Microbial Nucleic Acid Storage And Stabilization Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QBD
651in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBD
2in 2022
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · QBD
No MAUDE report names QBD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 2 (2) | 0 |
| 2023 | 5 | 286 | 0 | 0 |
| 2024 | 5 | 651 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170029 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170029: PrimeStore MTM.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170029
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026