QRV — Setmelanotide Eligibility Gene Variant Detection System Class II
FDA product code QRV covers "Setmelanotide Eligibility Gene Variant Detection System", a Class II medical device regulated under 21 CFR 862.1164. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QRV
- Device Class
- Class II
- Regulation Number
- 862.1164
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200059 | preventiongenetics | POMC/PCSK1/LEPR CDx Panel | January 21, 2022 |