BEUDAMED
    Product Code: PFR FDA class 2 21 CFR 866.5900

    System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

    Immunology

    The CFTR Gene Mutations and Variants Panel Sequencing Detection System is a molecular diagnostic device used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene via sequencing methods, intended for carrier screening and as an aid in confirmatory diagnostic testing for cystic fibrosis (CF). It is an FDA Class 2 device regulated under 21 CFR 866.5900, requiring 510(k) clearance, and falls under the Immunology (IM) medical specialty with review by the Pathology (PA) panel. The product code is PFR. The system is not intended for stand-alone diagnosis, prenatal diagnostic testing, or pre-implantation screening.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PFR
    Device Class
    FDA class 2
    Regulation Number
    866.5900
    Medical Specialty
    Immunology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K124006 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.