BEUDAMED
    Product Code: PFS FDA class 2 21 CFR 866.5900

    System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

    Immunology

    The CFTR Gene Variant Gene Sequence Detection System is a molecular diagnostic device used to sequence specified regions of the CFTR gene to detect variants, intended as an aid in confirmatory diagnostic testing for individuals with suspected cystic fibrosis, atypical CF presentations, or when other mutation panels have failed to identify both causative mutations. It is an FDA Class 2 device regulated under 21 CFR 866.5900, requiring 510(k) clearance, classified under the Immunology (IM) specialty with Pathology (PA) panel review. The product code is PFS. The device is not intended for carrier screening, newborn screening, prenatal diagnosis, or stand-alone diagnostic use.

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

    Basic Information

    Product Code
    PFS
    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 variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes

    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
    K132750 ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING 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.