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510(k) Data Aggregation

    K Number
    K133302
    Device Name
    FLEXMAP 3D
    Manufacturer
    LUMINEX CORP.
    Date Cleared
    2014-01-10

    (77 days)

    Product Code
    NSU
    Regulation Number
    862.2570
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Luminex® FLEXMAP 3D® system with xPONENT® software is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a formal letter from the FDA regarding a 510(k) premarket notification for the Luminex FLEXMAP 3D device. It confirms the substantial equivalence of the device and outlines general regulatory obligations.

    The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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