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510(k) Data Aggregation

    K Number
    K990431
    Device Name
    AIA-PACK CA 125
    Manufacturer
    TOSOH MEDICS, INC.
    Date Cleared
    1999-06-03

    (112 days)

    Product Code
    LTK
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    K023891
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AIA-PACK CA 125 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on TOSOH AIA System analyzers. AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the AIA-PACK CA 125 Assay. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. However, the document does NOT contain a study or data proving the device meets specific acceptance criteria, nor does it detail any of the requested information regarding sample sizes, ground truth establishment, or expert involvement in a study.

    Therefore, I cannot provide the requested table and study details from the provided text. The document is an administrative clearance, not a scientific study report.

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