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    K Number
    K042281
    Device Name
    MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2004-09-16

    (23 days)

    Product Code
    JLW
    Regulation Number
    862.1690
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K023093,K954825,K925637
    Why did this record match?
    Device Name :

    MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Access HYPERsensitive hTSH Assay provides in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and/or the 2nd generation (Fast hTSH) results.

    Device Description

    The Access® hTSH assay consists of the reagent pack and calibrators. Other items needed to perform the assay include the diluent, substrate and wash buffers.

    AI/ML Overview

    This document is a 510(k) summary for the Access HYPERsensitive hTSH Assay. It does not contain information about acceptance criteria or specific studies detailing device performance against those criteria. The provided text primarily focuses on the device description, intended use, technological characteristics, and its substantial equivalence to previously cleared devices.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is essentially a regulatory filing, not a scientific publication detailing performance studies.

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