FDA product code QBX: Direct Blood Bacterial Nucleic Acid Detection System
QBX is the FDA product code for direct blood bacterial nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3960 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QBX, 1 in the last five years. The average 510(k) review took 196 days (median 196); 133 days on average over the last three years.
Definition
Amplification, detection and identification of microbial pathogens directly from whole blood specimens
Classification
| Field | Value |
|---|---|
| Device name | Direct Blood Bacterial Nucleic Acid Detection System |
| Device class | Class II |
| Regulation | 21 CFR 866.3960 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QBX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 258 |
| 2024 | 1 | 133 |
Compare with all 510(k) review times · Search every QBX clearance
Top QBX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| T2biosystems, Inc. | 2 | 2024-02-08 |
Most recent QBX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233184 | T2biosystems, Inc. | T2Bacteria® Panel | 2024-02-08 | 133 |
| K172708 | T2biosystems, Inc. | T2Bacteria Panel | 2018-05-24 | 258 |
Recalls for QBX devices
openFDA lists no recalls for product code QBX.
Frequently asked questions
What is FDA product code QBX?
QBX is the FDA product code for direct blood bacterial nucleic acid detection system. It is a Class II device, regulated under 21 CFR 866.3960 and reviewed by the Microbiology panel.
What device class is QBX?
Class II, regulation 21 CFR 866.3960. Typical premarket route: 510(k).
How long does a 510(k) take for product code QBX?
Across 2 cleared submissions the average was 196 days from receipt to decision (median 196).
Which companies have the most QBX clearances?
T2biosystems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QBX
- Run a recall and safety report across every QBX manufacturer
- Watch product code QBX 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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