FDA product code QRV: Setmelanotide Eligibility Gene Variant Detection System
QRV is the FDA product code for setmelanotide eligibility gene variant detection system. It is a Class II device, regulated under 21 CFR 862.1164 and reviewed by the Clinical Chemistry panel. Devices under QRV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A setmelanotide eligibility gene variant detection system is a qualitative in vitro diagnostic device intended to detect germline variants within genes isolated from human specimens for the purpose of identifying patients with obesity who may benefit from treatment with setmelanotide in accordance with the approved therapeutic product labeling.
Classification
| Field | Value |
|---|---|
| Device name | Setmelanotide Eligibility Gene Variant Detection System |
| Device class | Class II |
| Regulation | 21 CFR 862.1164 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
Recalls for QRV devices
openFDA lists no recalls for product code QRV.
Frequently asked questions
What is FDA product code QRV?
QRV is the FDA product code for setmelanotide eligibility gene variant detection system. It is a Class II device, regulated under 21 CFR 862.1164 and reviewed by the Clinical Chemistry panel.
What device class is QRV?
Class II, regulation 21 CFR 862.1164. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QRV
- Run a recall and safety report across every QRV manufacturer
- Watch product code QRV 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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