BEUDAMED
    Product Code: PFX FDA class 2 21 CFR 866.5920

    System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

    Immunology

    The Microarray-Based Genome-Wide Postnatal Chromosomal Abnormality Detection System is a diagnostic device used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods, intended as an aid in the postnatal diagnosis of developmental delay, intellectual disability, congenital anomalies, and dysmorphic features. It is an FDA Class 2 device regulated under 21 CFR 866.5920, requiring 510(k) clearance, within the Immunology (IM) specialty with Pathology (PA) panel review. The product code is PFX. The device is not intended for standalone diagnosis, prenatal or pre-implantation testing, population screening, or detection of acquired genetic aberrations.

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    510(k)s
    2
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    2
    Years Active
    4

    Basic Information

    Product Code
    PFX
    Device Class
    FDA class 2
    Regulation Number
    866.5920
    Medical Specialty
    Immunology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

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

    Definition

    A microarray-based, genome-wide, postnatal chromosomal abnormality detection system is used to qualitatively detect constitutional gains and losses in chromosomal copy numbers across the human genome using microarray methods. It is intended as an aid in the postnatal diagnosis of developmental delay and/or intellectual disability (DD/ID), congenital anomalies, and dysmorphic features in conjunction with other clinical information currently used in postnatal diagnosis. It is not intended to be used for standalone diagnostic purposes, prenatal or pre-implantation testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K163367 GenetiSure Dx Postnatal Assay
    DEN130018 CYTOSCAN(R) DX

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.