# DEN200059: POMC/PCSK1/LEPR CDx Panel

- Pathway: De Novo (Direct)
- Applicant: Preventiongenetics, LLC
- Decided: Jan 21, 2022 after 490 days
- Product code: QRV (Setmelanotide Eligibility Gene Variant Detection System)
- Device class: 2
- Regulation: 21 CFR 862.1164
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The POMC/PCSK1/LEPR CDx Panel is a next generation sequencing (NGS)-based in vitro diagnostic test that analyzes genomic DNA isolated from blood or saliva. Specimens used with the test are K2EDTA blood collected using certain indicated K2EDTA blood collection devices and saliva collected using ORAcollect-Dx™ OCD-100 devices. The test detects germline nucleotide substitutions, short insertions and deletions, and copy number variants (CNVs) within the following 3 genes: • Pro-opiomelanocortin (POMC) • Proprotein Convertase Subtilisin/Kexin type 1 (PCSK1) • Leptin Receptor (LEPR) The test is a companion diagnostic device intended to select adult and pediatric patients 6 years of age and older who have obesity and certain variants in POMC, PCSK1 or LEPR genes for treatment with IMCIVREE® (setmelanotide) in accordance with the approved therapeutic product labeling. The POMC/PCSK1/LEPR CDx Panel is a single-site assay performed at PreventionGenetics, LLC (Marshfield, WI).

Source page: https://510kreport.com/device/DEN200059
Methodology: https://510kreport.com/methodology