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510(k) Data Aggregation

    K Number
    DEN200059
    Device Name
    POMC/PCSK1/LEPR CDx Panel
    Date Cleared
    2022-01-21

    (490 days)

    Product Code
    Regulation Number
    862.1164
    Why did this record match?
    Applicant Name (Manufacturer) :

    PreventionGenetics, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended 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 K-EDTA blood collected using certain indicated K-EDTA 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 (PCSKI) . - 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, PCSKI 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).
    Device Description
    The POMC/PCSK1/LEPR CDx Panel is a next generation sequencing (NGS) assay for the detection of germline variants in three genes (pro-opiomelanocortin (POMC), leptin receptor (LEPR), and convertase subtilisin/kexin type 1 (PCSK1)). The POMC/PCSK1/LEPR CDx Panel is performed in a single laboratory (PreventionGenetics, LLC in Marshfield, WI).
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