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510(k) Data Aggregation

    K Number
    K060139
    Device Name
    CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2006-04-28

    (99 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CRP-ADVANCE ASSAY, MODELS 250-20, 250-25

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

    For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.

    Device Description

    A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a device called "CRP-ADVANCE." It describes the device's indications for use and general regulatory information but does not contain a study report or detailed acceptance criteria with performance results.

    Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

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