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510(k) Data Aggregation

    K Number
    K012855
    Device Name
    LIQUISPX LIQUID LIPID CONTROL
    Manufacturer
    CLINICAL CONTROLS DIVISION
    Date Cleared
    2001-08-30

    (6 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Clinical Controls LiquiSPx Liquid Lipid control is a ready-to-use, assayed chemistry control material for monitoring the accuracy and precision of lipid chemistry control material for monitoring the automated analytical procedures. Lipid analysis consists of measuring total cholesterol, triglycerides, HDL and LDL cholesterol. It is used to assist in the diagnosis and management of LDL cholesterol. This dood to assist in tisk patient populations.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML medical device. The document is an FDA 510(k) clearance letter for a "LiquiSPx Liquid Lipid Control" which is a chemical control material used in laboratory settings, not an AI/ML device. Therefore, I cannot fulfill your request based on the given input.

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