510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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DEN200059Unknown

POMC/PCSK1/LEPR CDx Panel

Preventiongenetics, LLC, Marshfield WI / Direct, Unknown
FDA source (opens on fda.gov)

DEN200059 is the FDA 510(k) clearance record for POMC/PCSK1/LEPR CDx Panel, a class II device, cleared for Preventiongenetics, LLC on under FDA product code QRV (Setmelanotide Eligibility Gene Variant Detection System). FDA's definition for product code QRV reads: "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...". FDA records list one 510(k) clearance for Preventiongenetics, LLC. As of , FDA records show no recalls naming DEN200059.

Clearance record

Decision date
Received
(490 days to decision)
Product code
QRV Setmelanotide Eligibility Gene Variant Detection System
Regulation
21 CFR 862.1164
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Preventiongenetics, LLC 3800 S. Business Park Ave., Marshfield WI
Third party review
No

Clearances, product code QRV

Trailing 12 months

FDA records hold no clearances under product code QRV in the trailing twelve months.

FDA records show no clearances under product code QRV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QRV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260