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510(k) Data Aggregation

    K Number
    K023250
    Device Name
    LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2002-10-17

    (17 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

    LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for the Beckman-Coulter Immage™ is intended for use as an assayed quality control material for analysis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a quality control material, LiniCAL™ Protein 2 Calibration Verifiers. This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) submission itself, which is a much more extensive document than the clearance letter.

    Therefore, I cannot provide the requested information based solely on the text provided. The document primarily serves as a notification of regulatory clearance.

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