Setmelanotide Eligibility Gene Variant Detection System
QRV · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1164
Classification
FDA Product Code
QRV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1164
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.