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510(k) Data Aggregation

    K Number
    K061613
    Device Name
    VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
    Manufacturer
    TRIPATH IMAGING
    Date Cleared
    2007-01-10

    (215 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 - PATHWAY HER2 (4B5)

    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 for the semi-quantitative detection of c-erbB-2 (HER2) antigen in formalin-fixed, paraffin-embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER2 proteins using Ventana® Medical Systems, Inc.'s (Ventana) PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as well as Ventana's DAB copper chromogen and nuclear hematoxylin.

    Ventana's PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered.

    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 HER2 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 PATHWAY HER2 (4B5) to assure the validity of the VIAS-assisted HER2.

    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

    The provided text describes the 510(k) premarket notification for the Ventana Image Analysis System - PATHWAY® HER2 (4B5). While it outlines the device's indications for use and regulatory information, it does not contain specific details about the acceptance criteria, the study proving the device meets those criteria, or the methodology of such a study.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

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