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    K Number
    K023240
    Device Name
    ST AIA-PACK CA 19-9
    Manufacturer
    TOSOH CORP.
    Date Cleared
    2002-12-23

    (87 days)

    Product Code
    NIG
    Regulation Number
    866.6010
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ST AIA-PACK CA 19-9

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

    ST AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers. Serial testing using the ST AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.

    Device Description

    Not Found

    AI/ML Overview

    This is a medical device approval letter. It does not provide the information needed to answer the request. The letter confirms the FDA's decision that the "ST AIA-PACK TM CA 19-9" device is substantially equivalent to legally marketed predicate devices. It discusses regulatory information and marketing authorization but does not contain details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a performance study.

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