FDA Product Code QRV: Setmelanotide Eligibility Gene Variant Detection System
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.
Leading manufacturers include Preventiongenetics, LLC.
FDA 510(k) Cleared Setmelanotide Eligibility Gene Variant Detection System Devices (Product Code QRV)
About Product Code QRV - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QRV since 2022, with 0 receiving FDA clearance (average review time: 490 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QRV devices are reviewed by the Chemistry panel. Browse all Chemistry devices →