510(k) · Cleared
ClearedSample Preservative Fluid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Bioer Technology Co., Ltd. · QBD Microbial Nucleic Acid Storage And Stabilization Device
Cleared on Jun 26, 2024 as substantially equivalent to DEN170029 (Longhorn Vaccines and Diagnostics, LLC, 2018) after a 651-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Jun 26, 2024
- Review
- 651 days
- Class
- Class II
- Product code
- QBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170029 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170029 PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC · 2018
- This deviceK222771 Sample Preservative FluidHangzhou Bioer Technology Co., Ltd. · 2024
View 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) | K222771 | Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 2024 | — |
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 4…duct code QBD Regulation No. 21 CFR 866.2950 3. Legally Marketed Predicate Device Trade Name PrimeStore MTM 510(k) Number DEN170029 Product Code QBD Manufacturer Longhorn Vaccines and Diagnostics, LLC… | 2018 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate DEN170029.
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. 2024, 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?
The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222771: Sample Preservative Fluid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222771
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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