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510(k) Data Aggregation

    K Number
    K990317
    Device Name
    ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
    Manufacturer
    BIO-RAD
    Date Cleared
    1999-03-18

    (48 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

    Liquid Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the anlaytes listed in the value sheet.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, study details, or performance metrics for the Abbott Liquid Urine Chemistry Control device.

    The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It discusses regulatory classifications, general controls, and contact information for further inquiries. It also includes the "Indications for Use" for the device.

    However, it does not contain any data from a study that would demonstrate the device meets specific acceptance criteria. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

    Therefore, I cannot provide the requested table or answer any of the detailed questions about studies, sample sizes, ground truth, or expert involvement.

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