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    K Number
    K061377
    Device Name
    APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2007-03-28

    (315 days)

    Product Code
    MSJ,JIT
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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

    These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a clearance letter from the FDA for an in vitro diagnostic device, specifically for Apolipoprotein A1 and Apolipoprotein B reagents and calibrators. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.

    The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include data from a specific performance study.

    Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document detailing the actual performance study conducted for the device's clearance.

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