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

    (490 days)

    Product Code
    QRV
    Regulation Number
    862.1164
    Type
    Direct
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K152464
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    ----------------------|----------------------------|
    | QRV | Class II | 21 CFR 862.1164
    ORV Device Type: Setmelanotide eligibility gene variant detection system Class: II Regulation: 21 CFR 862.1164

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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).

    AI/ML Overview

    Acceptance Criteria and Device Performance for POMC/PCSK1/LEPR CDx Panel

    The POMC/PCSK1/LEPR CDx Panel is a next-generation sequencing (NGS)-based in vitro diagnostic test for detecting germline variants in POMC, PCSK1, and LEPR genes, intended to select patients for treatment with IMCIVREE (setmelanotide). The acceptance criteria primarily revolve around the analytical performance of the device, focusing on accuracy, precision, and specificity.

    1. Table of Acceptance Criteria and Reported Device Performance

    Given the nature of the device (a genetic variant detection system), the acceptance criteria are generally established through analytical performance metrics like Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and Overall Percent Agreement (OPA) when compared to validated orthogonal methods.

    Acceptance Criteria (Metric, Threshold)Reported Device Performance (Value, 95% CI)Study Name
    Analytical Accuracy (Method Comparison)
    PPA (Variant/Non-variant base level)100% (99.85%, 100.00%)Method Comparison Study
    NPA (Variant/Non-variant base level)100% (99.99%, 100.00%)Method Comparison Study
    OPA (Variant/Non-variant base level)100% (99.99%, 100.00%)Method Comparison Study
    PPA (Clinical Bridging - Local Test vs. Device, Pivotal Subjects)100% (84.5%, 100.0%)Clinical Bridging Study
    PPA (Clinical Bridging - Local Test vs. Device, Pivotal + Supplemental Subjects)96.7% (83.3%, 99.4%)Clinical Bridging Study
    Analytical Precision (Reproducibility)
    OPA (Whole Blood, Variant/Non-variant base level)100% (100.00%, 100.00%)Precision Study (additional runs)
    PPA (Whole Blood, Variant/Non-variant base level)100% (99.72%, 100.00%)Precision Study (additional runs)
    NPA (Whole Blood, Variant/Non-variant base level)100% (100.00%, 100.00%)Precision Study (additional runs)
    OPA (Saliva, Variant/Non-variant base level)100% (100.00%, 100.00%)Precision Study (additional runs)
    PPA (Saliva, Variant/Non-variant base level)100% (99.72%, 100.00%)Precision Study (additional runs)
    NPA (Saliva, Variant/Non-variant base level)100% (100.00%, 100.00%)Precision Study (additional runs)
    Analytical Specificity (Interference)
    Sequence Agreement (Blood substances)b(4) % (exact value redacted)Interference Study
    Sequence Agreement (Saliva substances)b(4) % (exact value redacted)Interference Study
    Sequence Agreement (DNA extraction components)b(4) % (exact value redacted)Interference Study
    Analytical Specificity (Cross-contamination)
    Percentage contamination (ART
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