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510(k) Data Aggregation

    K Number
    K022591
    Device Name
    RANDOX LIPID CONTROL
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2002-08-30

    (25 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RANDOX LIPID CONTROL

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

    The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.

    Device Description

    The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume.

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Randox Lipid Control, stating that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain any information about acceptance criteria or a study proving device performance related to a specific clinical outcome or diagnostic accuracy.

    The device described is a "Quality Control Material" for clinical chemistry applications, specifically lipid monitoring. Its stated "Indications For Use" are: "The Randox Laboratories Limited Lipid Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, specifically lipid monitoring. The control materials are available at three constituent concentrations. Each level is available in a 1ml and 3ml final re-constituted volume."

    Therefore, I cannot provide the requested information from this document. The typical studies and criteria you've asked about (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are relevant to diagnostic devices or AI algorithms that provide clinical insights or diagnoses. This document pertains to a quality control material used to ensure the proper functioning of laboratory equipment.

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