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510(k) Data Aggregation

    K Number
    K053520
    Device Name
    VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
    Manufacturer
    TRIPATH IMAGING, INC.
    Date Cleared
    2006-04-11

    (113 days)

    Product Code
    NQN
    Regulation Number
    864.1860
    Type
    Traditional
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67

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

    The Ventana Image Analysis System (VIAS) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection, classification and counting of cells of interest based on marker intensity, size and shape using appropriate controls to assure the validity of the VIAS scores.

    In this application, the VIAS is intended to aid a qualified pathologist in the acquisition and measurement of images to quantify the percentage of positively stained nuclei in paraffin embedded breast cancer tissue specimens immunohistochemically stained for the presence of Ki-67 proteins using Ventana's reagents and nuclear hematoxylin. It is indicated for use in assessing the proliferative activity of normal and neoplastic breast tissue when used with in vitro diagnostic reagents marketed for these indications.

    The VIAS is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of Ki-67 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Ventana Ki-67 kit to assure the validity of the VIAS-assisted Ki-67 assessment.

    Device Description

    The Ventana Image Analysis System (VIAS) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Ventana Image Analysis System-Ki-67. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria. The letter primarily focuses on the regulatory clearance of the device as substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text.

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