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510(k) Data Aggregation

    K Number
    K982003
    Device Name
    DS30 HCY HOMOCYSTEINE ASSAY KIT
    Manufacturer
    DREW SCIENTIFIC LTD.
    Date Cleared
    1999-02-11

    (248 days)

    Product Code
    LPS
    Regulation Number
    862.1377
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DS30 HCY HOMOCYSTEINE ASSAY KIT

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

    In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA document (K982003) is a 510(k) clearance letter for a diagnostic device (DS30 Hcy Homocysteine Assay Kit), not a study report. It states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, the document does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics. These details would typically be found in the device's premarket submission or a separate validation study report, not in the clearance letter itself.

    The document only specifies:

    • Device Name: DS30 Hcy Homocysteine Assay Kit
    • Intended Use: In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.

    Without a detailed study report, I cannot provide the requested information.

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