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510(k) Data Aggregation

    K Number
    K082107
    Device Name
    CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2008-09-17

    (54 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 :

    CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

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

    CLINIQA® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2 are intended for use as an assayed quality control material. It is not intended for use as a standard. Assay values for analytes listed in this product insert are provided for both levels.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry but this document does not contain the information you are looking for. This is a 510(k) premarket notification letter from the FDA to Cliniqa Corporation regarding their Liquid QC Urine Chemistry Controls. It confirms the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth information.

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