FDA product code QMV: Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
QMV is the FDA product code for device to detect and identify selected microbial agents that cause acute febrile illness. It is a Class II device, regulated under 21 CFR 866.3966 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QMV, 2 in the last five years, from 2 different applicants. The average 510(k) review took 118 days (median 118); 27 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.
Classification
| Field | Value |
|---|---|
| Device name | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness |
| Device class | Class II |
| Regulation | 21 CFR 866.3966 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QMV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 209 |
| 2024 | 1 | 27 |
Compare with all 510(k) review times · Search every QMV clearance
Top QMV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofire Diagnostics, LLC (Biomerieux) | 1 | 2024-12-05 |
| Biofire Defense, LLC | 1 | 2022-10-20 |
Most recent QMV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243463 | Biofire Diagnostics, LLC (Biomerieux) | BIOFIRE FILMARRAY Tropical Fever Panel | 2024-12-05 | 27 |
| K220870 | Biofire Defense, LLC | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | 2022-10-20 | 209 |
Recalls for QMV devices
openFDA lists no recalls for product code QMV.
Frequently asked questions
What is FDA product code QMV?
QMV is the FDA product code for device to detect and identify selected microbial agents that cause acute febrile illness. It is a Class II device, regulated under 21 CFR 866.3966 and reviewed by the Microbiology panel.
What device class is QMV?
Class II, regulation 21 CFR 866.3966. Typical premarket route: 510(k).
How long does a 510(k) take for product code QMV?
Across 2 cleared submissions the average was 118 days from receipt to decision (median 118).
Which companies have the most QMV clearances?
Biofire Diagnostics, LLC (Biomerieux) (1); Biofire Defense, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QMV
- Run a recall and safety report across every QMV manufacturer
- Watch product code QMV 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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