510(k) · Cleared
ClearedBiosci™ Inactivated Transport Medium, Biosci™ ITM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dakewe Bio-Engineering Co., Ltd. · QBD Microbial Nucleic Acid Storage And Stabilization Device
Cleared on Jan 19, 2023 as substantially equivalent to K201849 (Copan Italia Spa, 2020) after a 374-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Jan 19, 2023
- Review
- 374 days
- Class
- Class II
- Product code
- QBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170029 (2018). No later device cites it as a predicate yet.
- Root · 2 generations backDEN170029 PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 2018
- 1 generation backK201849 eNAT molecular collection and preservation mediumCopan Italia Spa · 2020
- This deviceK220059 Biosci™ Inactivated Transport Medium, Biosci™ ITMShenzhen Dakewe Bio-Engineering Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | 2018 | — |
| −1 | K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | 2020 | — |
| 0 (this device) | K220059 | Biosci™ Inactivated Transport Medium, Biosci™ ITM | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K201849 | eNAT molecular collection and preservation mediumSummary page 4…ON Device Name eNAT® - molecular collection and preservation medium 510(k) Number K201849 Device Transport device for the stabilization of microbial n… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K201849.
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. 2023, 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?
Biosci™ Inactivated Transport Medium (Biosci™ ITM) is intended for the collection, inactivation, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220059: Biosci™ Inactivated Transport Medium, Biosci™ ITM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220059
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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