QRV

Setmelanotide Eligibility Gene Variant Detection System

Product code

QRV

Device name

Setmelanotide Eligibility Gene Variant Detection System

Device class

Class 2

21 CFR

21 CFR 862.1164

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).