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510(k) Data Aggregation

    K Number
    K042443
    Device Name
    SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
    Manufacturer
    ARKRAY, INC.
    Date Cleared
    2004-11-24

    (76 days)

    Product Code
    CHH,CDT,LBS
    Regulation Number
    862.1175
    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 SpotChem EZ Total Cholesterol, HDL and Triglyceride test and panel system are an in vitro diagnostic procedures intended to measure Total Cholesterol/HDL Triglyceride quantitatively in human serum and plasma on the SpotChem EZ analyzer.

    Total Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

    HDL-Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

    Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

    Device Description

    Not Found

    AI/ML Overview

    This a 510(k) summary for "The SpotChem EZ Total Cholesterol, HDL and Triglyceride Individual Tests and Panel Tests". The document focuses on the regulatory clearance for this in vitro diagnostic device and does not contain detailed information about acceptance criteria, specific study designs, or performance metrics in the format requested.

    Therefore, I cannot provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is a regulatory letter of substantial equivalence and does not include the detailed technical study information.

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