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510(k) Data Aggregation

    K Number
    K080094
    Device Name
    OLYMPUS TOTAL BHCG TEST SYSTEN
    Manufacturer
    OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)
    Date Cleared
    2008-09-03

    (233 days)

    Product Code
    DHA,JIT,JJX
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OLYMPUS TOTAL BHCG TEST SYSTEN

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

    The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System. Total BhCG is used for the early detection of pregnancy. For in vitro diagnostic use only.

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

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

    Device Description

    The Olympus Total BhCG Test System (OS210303). The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System.

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Olympus Total BhCG Test System, confirming its substantial equivalence to a legally marketed predicate device. It defines the device, its intended use, and regulatory information but does not include details on specific performance metrics, acceptance criteria, or a study report.

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