Setmelanotide Eligibility Gene Variant Detection System
The Setmelanotide Eligibility Gene Variant Detection System is a qualitative in vitro diagnostic device intended to detect germline variants in specific genes isolated from human specimens to identify patients with obesity who may benefit from treatment with setmelanotide, a melanocortin-4 receptor agonist. It functions as a companion diagnostic to guide therapeutic eligibility decisions. Classified as FDA Class 2 under regulation 862.1164, it requires 510(k) clearance and falls under the Clinical Chemistry specialty. The device is not an implant and not life-sustaining.
Basic Information
- Product Code
- QRV
- Device Class
- FDA class 2
- Regulation Number
- 862.1164
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200059 | POMC/PCSK1/LEPR CDx Panel | Jan 21, 2022 | Unknown | Preventiongenetics, LLC |