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510(k) Data Aggregation

    K Number
    K030768
    Device Name
    CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2003-03-21

    (10 days)

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

    CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL

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

    CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL is intended for use as an assayed quality control material for analysis.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) substantial equivalence determination letter from the FDA for a quality control material (CLINIQA Liquid QC™ Cardiac Marker Controls Levels 1, 2 & 3 Tri-LEVEL). It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of a diagnostic or therapeutic medical device.

    Specifically, the document:

    • Identifies the device as a quality control material.
    • States its intended use is as an assayed quality control material for analysis.
    • Confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices.

    This type of FDA clearance pertains to the marketing of a quality control product, not to the performance evaluation of a diagnostic device that might use such controls. Therefore, the information requested in your prompt (Table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in this document.

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