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510(k) Data Aggregation

    K Number
    K984145
    Device Name
    OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
    Manufacturer
    OLYMPUS DIAGNOSTICA GMBH
    Date Cleared
    1998-12-23

    (34 days)

    Product Code
    DDR
    Regulation Number
    866.5680
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT

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

    The Olympus Myoglobin reagent is intended to be utilized for the quantitative determination of myoglobin in human serum on Olympus analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the Olympus Myoglobin Turbidimetric Reagent. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study for a device.

    The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the clearance is based on a comparison to a legally marketed predicate device, not necessarily a new, extensive performance study with the specific details you are asking for.

    Therefore, I cannot provide the requested information based on the input text.

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