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510(k) Data Aggregation

    K Number
    K993853
    Device Name
    K-ASSAY MULTI-ANALYTE CALIBRATOR
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-12-27

    (45 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The K-ASSAY Multi-Analyte Calibrator is intended to be used for the calibration of the following K-ASSAY immunoturbidimetric assays for quantitating serum proteins: Alpha-1 Antitrypsin, Alpha-1 Acid Glycoprotein, C3, C4, IgA, IgG, IgM, Haptoglobin, Transferrin

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "K-ASSAY Multi-Analyte Calibrator." It defines the intended use and regulatory classification of the device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/device performance evaluation.

    Therefore, I cannot provide the requested information. The text is entirely focused on regulatory approval based on substantial equivalence to a predicate device, not on a detailed performance study of the device itself.

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