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510(k) Data Aggregation

    K Number
    K081709
    Device Name
    OLYMPUS AFP - ALPHA-FETOPROTEIN
    Manufacturer
    OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
    Date Cleared
    2009-03-16

    (272 days)

    Product Code
    LOJ,JIT,JJY
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Olympus AFP assay is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management of patients with non-seminomatous germ cell tumors.

    For in vitro diagnostic use only.

    The Olympus AFP Calibrator is for calibrating the quantitative Olympus AFP assay on the Olympus AU3000i Immunoassay System.

    The Olympus AFP Control is used for quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.

    Device Description

    The Olympus Alpha-fetoprotein (AFP) Test System is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System.

    AI/ML Overview

    The provided text is a 510(k) premarket notification acceptance letter for the Olympus AFP Test System. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to a legally marketed predicate device but does not detail the performance metrics or study design.

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

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