FDA product code QUU: Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
QUU is the FDA product code for simple in vitro diagnostic device for the detection of secreted proteins from bacillus spp. in human clinical samples. It is a Class II device, regulated under 21 CFR 866.3046 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QUU, 1 in the last five years. The average 510(k) review took 90 days (median 90). 1 De Novo request was granted under it.
Definition
A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device is simple to use and does not involve sample manipulation or measurement of an analyte that could be affected by conditions such as sample turbidity or cell lysis. This device may be used to aid in the presumptive diagnosis of anthrax in individuals who have signs and symptoms consistent with anthrax and a likelihood of exposure. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, gastrointestinal disease, non-gastrointestinal infections, and an anthrax-like illness caused by B. cereus.
Classification
| Field | Value |
|---|---|
| Device name | Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples |
| Device class | Class II |
| Regulation | 21 CFR 866.3046 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QUU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 90 |
Compare with all 510(k) review times · Search every QUU clearance
Top QUU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| First Light Diagnostics, Inc. | 1 | 2023-11-20 |
Most recent QUU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232545 | First Light Diagnostics, Inc. | The SensiTox B. anthracis Toxin Test | 2023-11-20 | 90 |
Recalls for QUU devices
openFDA lists no recalls for product code QUU.
Frequently asked questions
What is FDA product code QUU?
QUU is the FDA product code for simple in vitro diagnostic device for the detection of secreted proteins from bacillus spp. in human clinical samples. It is a Class II device, regulated under 21 CFR 866.3046 and reviewed by the Microbiology panel.
What device class is QUU?
Class II, regulation 21 CFR 866.3046. Typical premarket route: 510(k).
How long does a 510(k) take for product code QUU?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most QUU clearances?
First Light Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QUU
- Run a recall and safety report across every QUU manufacturer
- Watch product code QUU 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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