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510(k) DEN200059

POMC/PCSK1/LEPR CDx Panel by Preventiongenetics, LLC — Product Code QRV

DEN200059 is an FDA 510(k) premarket notification submitted by Preventiongenetics, LLC for the device "POMC/PCSK1/LEPR CDx Panel". The FDA issued a decision of De Novo granted on Jan 21, 2022. The device falls under product code QRV (Setmelanotide Eligibility Gene Variant Detection System), a Class II device regulated under 21 CFR 862.1164.

Clearance Details

Decision
DENG (De Novo granted)
Decision Date
Jan 21, 2022
Date Received
Sep 18, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Setmelanotide Eligibility Gene Variant Detection System
Device Class
Class II
Regulation Number
862.1164
Review Panel
CH
Submission Type
510(k)

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.

FDA data resources