FDA product code QBD: Microbial Nucleic Acid Storage And Stabilization Device
QBD is the FDA product code for microbial nucleic acid storage and stabilization device. It is a Class II device, regulated under 21 CFR 866.2950 and reviewed by the Microbiology panel. FDA has cleared 16 510(k) submissions under QBD, 13 in the last five years, from 15 different applicants. The average 510(k) review took 348 days (median 274); 406 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 7 recalls for QBD devices, 2 initiated in the last five years.
Definition
Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.
Classification
| Field | Value |
|---|---|
| Device name | Microbial Nucleic Acid Storage And Stabilization Device |
| Device class | Class II |
| Regulation | 21 CFR 866.2950 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QBD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 84 |
| 2021 | 1 | 220 |
| 2022 | 2 | 410 |
| 2023 | 5 | 262 |
| 2024 | 5 | 561 |
| 2025 | 1 | 251 |
Compare with all 510(k) review times · Search every QBD clearance
Top QBD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zymo Research | 2 | 2023-09-28 |
| Puritan Medical Products, LLC | 1 | 2025-05-27 |
| Permantis Public Health | 1 | 2024-10-11 |
| Hangzhou Bioer Technology Co., Ltd. | 1 | 2024-06-26 |
| Alb Luz | 1 | 2024-06-17 |
10 more applicants have QBD clearances. See the full list in Caduvo.
Most recent QBD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242820 | Puritan Medical Products, LLC | Puritan PurSafe Plus Collection and Transport System | 2025-05-27 | 251 |
| K240797 | Permantis Public Health | PPH Saliva Collection Kit | 2024-10-11 | 203 |
| K222771 | Hangzhou Bioer Technology Co., Ltd. | Sample Preservative Fluid | 2024-06-26 | 651 |
| K233324 | Alb Luz | Molecular Transport Media - MTM | 2024-06-17 | 262 |
| K221547 | Fertipro NV | InActiv Blue | 2024-06-11 | 746 |
Recalls for QBD devices
7 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-08-09.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code QBD?
QBD is the FDA product code for microbial nucleic acid storage and stabilization device. It is a Class II device, regulated under 21 CFR 866.2950 and reviewed by the Microbiology panel.
What device class is QBD?
Class II, regulation 21 CFR 866.2950. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBD?
Across 16 cleared submissions the average was 348 days from receipt to decision (median 274).
Which companies have the most QBD clearances?
Zymo Research (2); Puritan Medical Products, LLC (1); Permantis Public Health (1); Hangzhou Bioer Technology Co., Ltd. (1); Alb Luz (1).
Have QBD devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2022-08-09.
Next steps
- Run an FDA pathway report with predicate devices for product code QBD
- Run a recall and safety report across every QBD manufacturer
- Watch product code QBD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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