LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992976
    Device Name
    K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-11-01

    (59 days)

    Product Code
    DDR
    Regulation Number
    866.5680
    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 Myoglobin Assay is intended to be used for the quantitative determination of Myoglobin in serum by latex particle enhanced immunoturbidimetric assay. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

    The K-ASSAY Myoglobin Multi-Calibrator is intended to be used for the calibration of the K-ASSAY Myoglobin Assay.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the K-ASSAY Myoglobin device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The document is a regulatory approval letter stating that the device is "substantially equivalent" to legally marketed predicate devices. It outlines the intended use of the device ("quantitative determination of Myoglobin in serum by latex particle enhanced immunoturbidimetric assay. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.") but provides no details about the studies or data that led to this determination.

    Therefore, I cannot provide the information requested in the prompt based on the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1