# K051282: Ventana Image Analysis System - HER2/Neu

- Pathway: 510(k) (Traditional)
- Applicant: Tripath Imaging, Inc.
- Decided: Aug 16, 2005 after 91 days
- Product code: NOT (Microscope, Automated, Image Analysis, Operator Intervention)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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 (HER-2/neu) in formalin-fixed, paraffin embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER-2/neu proteins using Ventana's HER-2/neu reagents as well as Ventana's DAB copper chromogen and nuclear hematoxylin. This particular application is an accessory to the Ventana PATHWAYTM Her2 (clone CB1 1) (Ventana Medical Systems, Inc., Tucson, Arizona) and the Ventana PATHWAYTM Her2 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 PATHWAYT' Her2 to assure the validity of the VIAS-assisted HER2 score. Note: All of the patients in the Herceptin® clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using PATHWAYTM Her2. The PATHWAYTh Her2 was compared to the DAKO HercepTest Tm on an independent sample and found to provide acceptably concordant results. The actual correlation of PATHWAY TM Her2 to clinical outcome has not been established.

Source page: https://510kreport.com/device/K051282
Methodology: https://510kreport.com/methodology