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510(k) Data Aggregation

    K Number
    K981978
    Device Name
    AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1998-07-22

    (47 days)

    Product Code
    MRR
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low density lipoprotein (LDL) cholesterol in serum or plasma. LDL cholesterol is a key factor in the pathogenesis of atherosclerosis and coronary artery disease. An increase in LDL cholestrerol can occur with an associated risk for coronary artery disease even within a normal total cholesterol concentration. This reagent set is intended for in vitro diagnostic use only.

    Device Description

    autoLDL Cholesterol Reagent Set

    AI/ML Overview

    The provided text is a cover letter from the FDA to Point Scientific, Inc. regarding their autoLDL Cholesterol Reagent Set and Calibrator. It states that the device has been found substantially equivalent to predicate devices and can be marketed.

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

    Therefore, I cannot provide the requested table and information. The document merely confirms the device's market clearance based on substantial equivalence, without detailing the specific data that led to that determination.

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