Product code QRV

Device name

Setmelanotide Eligibility Gene Variant Detection System

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1164

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset