FDA product code QVR: Multiplex Nucleic Acid Detection System For Biothreat Agents
QVR is the FDA product code for multiplex nucleic acid detection system for biothreat agents. It is a Class II device, regulated under 21 CFR 866.4000 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QVR, 3 in the last five years, from 3 different applicants. The average 510(k) review took 253 days (median 130); 102 days on average over the last three years.
Definition
A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens
Classification
| Field | Value |
|---|---|
| Device name | Multiplex Nucleic Acid Detection System For Biothreat Agents |
| Device class | Class II |
| Regulation | 21 CFR 866.4000 |
| Review panel | MI — Microbiology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for QVR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 2 | 328 |
| 2026 | 1 | 102 |
Compare with all 510(k) review times · Search every QVR clearance
Top QVR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cepheid | 1 | 2026-08-07 |
| T2biosystems, Inc. | 1 | 2023-09-15 |
| Biofire Defense, LLC | 1 | 2023-03-22 |
Most recent QVR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261362 | Cepheid | Xpert Hemorrhagic Fever | 2026-08-07 | 102 |
| K231336 | T2biosystems, Inc. | T2 Biothreat Panel | 2023-09-15 | 130 |
| K213362 | Biofire Defense, LLC | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | 2023-03-22 | 526 |
Recalls for QVR devices
openFDA lists no recalls for product code QVR.
Frequently asked questions
What is FDA product code QVR?
QVR is the FDA product code for multiplex nucleic acid detection system for biothreat agents. It is a Class II device, regulated under 21 CFR 866.4000 and reviewed by the Microbiology panel.
What device class is QVR?
Class II, regulation 21 CFR 866.4000. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVR?
Across 3 cleared submissions the average was 253 days from receipt to decision (median 130).
Which companies have the most QVR clearances?
Cepheid (1); T2biosystems, Inc. (1); Biofire Defense, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVR
- Run a recall and safety report across every QVR manufacturer
- Watch product code QVR 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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