FDA product code QBQ: System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
QBQ is the FDA product code for system, microbial growth monitor of normally sterile body fluid culture. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QBQ. The average 510(k) review took 264 days (median 264).
Definition
Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
Classification
| Field | Value |
|---|---|
| Device name | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture |
| Device class | Class I |
| Regulation | 21 CFR 866.2560 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QBQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 264 |
Compare with all 510(k) review times · Search every QBQ clearance
Top QBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bacterioscan, Inc. | 1 | 2018-05-01 |
Most recent QBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172412 | Bacterioscan, Inc. | BacterioScan 216Dx System | 2018-05-01 | 264 |
Recalls for QBQ devices
openFDA lists no recalls for product code QBQ.
Frequently asked questions
What is FDA product code QBQ?
QBQ is the FDA product code for system, microbial growth monitor of normally sterile body fluid culture. It is a Class I device, regulated under 21 CFR 866.2560 and reviewed by the Microbiology panel.
What device class is QBQ?
Class I, regulation 21 CFR 866.2560. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBQ?
Across 1 cleared submissions the average was 264 days from receipt to decision (median 264).
Which companies have the most QBQ clearances?
Bacterioscan, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QBQ
- Run a recall and safety report across every QBQ manufacturer
- Watch product code QBQ 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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