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510(k) Data Aggregation

    K Number
    K063224
    Device Name
    GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL
    Manufacturer
    GENTRIS CORPORATION
    Date Cleared
    2006-12-22

    (59 days)

    Product Code
    NZB
    Regulation Number
    866.5910
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GentriSure™ Human Genomic DNA Reference Control (HGDRC) is an independent. external run control that is intended for use in assessing the performance of diagnostic assays that detect cytochrome p450 2D6 (CYP2D6) genetic polymorphisms. This control is not intended to be used as a substitute for controls provided with licensed test kits. GentriSure HGDRC can be used for assay validation, staff training and proficiency testing, and as a quality control in routine in vitro diagnostic testing.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the "GentriSure ™ Human Genomic DNA Reference Control". It describes the intended use of the device and confirms its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study designs (MRMC, standalone).

    Therefore, I cannot provide the requested information based on the given text. The document is primarily an administrative letter granting market clearance, not a summary of the technical study data.

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