DeviceClearance

Product code QRV— Clinical Chemistry

POMC/PCSK1/LEPR CDx Panel

Classification name
Setmelanotide Eligibility Gene Variant Detection System
Device class
Class 2
Regulation
21 CFR 862.1164
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QRV under 21 CFR 862.1164, via openFDA

Market context for product code QRV

FDA has cleared 1 device under product code QRV, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QRV

Recent clearances under product code QRV

Data sourced from openFDA. This site is unofficial and independent of the FDA.