510(k) · Cleared
ClearedeNAT molecular collection and preservation medium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Copan Italia Spa · QBD Microbial Nucleic Acid Storage And Stabilization Device
Cleared on Sep 17, 2020 as substantially equivalent to DEN170029 (Longhorn Vaccines and Diagnostics, LLC, 2018) after a 73-day review. Its family tree reaches back 1 generation to 2018. 2 later devices descend from it.
- Decided
- Sep 17, 2020
- Review
- 73 days
- Class
- Class II
- Product code
- QBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170029 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN170029 PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 2018
- This deviceK201849 eNAT molecular collection and preservation mediumCopan Italia Spa · 2020
- Descendant · cites it directly · 0 of its ownK212878 Sample preservation solutionZhejiang Gene Science Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220059 Biosci™ Inactivated Transport Medium, Biosci™ ITMShenzhen Dakewe Bio-Engineering Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | 2018 | — |
| 0 (this device) | K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | 2020 | — |
| +1 | K212878 | Sample preservation solution | Zhejiang Gene Science Co., Ltd. | 2024 | — |
| +1 | K220059 | Biosci™ Inactivated Transport Medium, Biosci™ ITM | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170029 | PrimeStore MTMSummary page 6…ation medium III. PREDICATE DEVICE – CLASSIFICATION Device Name PrimeStore™ MTM 510(k) Number DEN170029 Device Transport device for the stabilization of microbial… | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2020, 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?
Copan eNAT- molecular collection and preservation medium- is intended for the stabilization, transportation and
inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA.
eNAT- molecular collection and preservation medium- is intended for use with compatible molecular assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201849: eNAT molecular collection and preservation medium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201849
Report an extraction error
Are you the manufacturer?
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