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510(k) Data Aggregation

    K Number
    K050632
    Device Name
    ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
    Manufacturer
    BAYER HEALTHCARE, LLC
    Date Cleared
    2005-05-26

    (78 days)

    Product Code
    LBS
    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 in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.

    The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.

    Device Description

    Not Found

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Direct HDL Cholesterol Method for ADVIA® Modular System (IMS), based on the provided 510(k) summary:

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance (ADVIA IMS)
    Imprecision
    Level ~37 mg/dLTotal CV (%) = 3.3
    Level ~55 mg/dLTotal CV (%) = 1.9
    Level ~83 mg/dLTotal CV (%) = 1.8
    Correlation
    Regression Slope0.986
    Intercept1.16
    R-value0.988
    Syx (mg/dL)2.29
    Analytical Range7 to 90 mg/dL

    Note: The document does not explicitly state numerical "acceptance criteria" values (e.g., "CV must be

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