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510(k) Data Aggregation

    K Number
    K093680
    Device Name
    DIAZYME CYSTATIN C ASSAY
    Manufacturer
    DIAZYME LABORATORIES
    Date Cleared
    2010-04-08

    (132 days)

    Product Code
    NDY
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K111664,K141143
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the Diazyme Cystatin C Assay. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data typically found in a 510(k) summary or the full submission.

    Therefore, I cannot provide a complete answer to your request based solely on the provided text. The document confirms the device's purpose as an in-vitro diagnostic test for Cystatin C to aid in the diagnosis and treatment of renal disease, but it lacks the specific performance data you are asking for.

    To answer your questions, I would need access to the 510(k) summary (which usually includes performance data) or the full 510(k) submission for K093680.

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