FDA product code QBH: Lower Respiratory Microbial Nucleic Acid Detection System
QBH is the FDA product code for lower respiratory microbial nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3985 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QBH. The average 510(k) review took 150 days (median 150). 1 De Novo request was granted under it. FDA has posted 4 recalls for QBH devices, 2 initiated in the last five years.
Definition
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Classification
| Field | Value |
|---|---|
| Device name | Lower Respiratory Microbial Nucleic Acid Detection System |
| Device class | Class II |
| Regulation | 21 CFR 866.3985 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QBH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 150 |
Compare with all 510(k) review times · Search every QBH clearance
Top QBH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Curetis GmbH | 1 | 2019-12-20 |
Most recent QBH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191967 | Curetis GmbH | Unyvero LRT BAL Application | 2019-12-20 | 150 |
Recalls for QBH devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-12-14.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code QBH?
QBH is the FDA product code for lower respiratory microbial nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3985 and reviewed by the Microbiology panel.
What device class is QBH?
Class II, regulation 21 CFR 866.3985. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBH?
Across 1 cleared submissions the average was 150 days from receipt to decision (median 150).
Which companies have the most QBH clearances?
Curetis GmbH (1).
Have QBH devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2023-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code QBH
- Run a recall and safety report across every QBH manufacturer
- Watch product code QBH 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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