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510(k) Data Aggregation

    K Number
    K014293
    Device Name
    K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    2002-02-19

    (53 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET

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

    The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and in the diagnosis and management of iron-related disorders such as hemochromatosis (iron overload) and iron deficiency anemia. The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay. For in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    This document, a 510(k) premarket notification, indicates FDA clearance for a device but does not contain detailed information about the acceptance criteria and the study that proves the device meets them. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone performance directly from the provided text. This information would typically be found in the device's documentation, such as a validation report or clinical study summary, which is not included here.

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