# K053520: Ventana Image Analysis System, Model KI-67

- Pathway: 510(k) (Traditional)
- Applicant: Tripath Imaging, Inc.
- Decided: Apr 11, 2006 after 113 days
- Product code: NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity)
- 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices 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.

## Most influential descendants
- K092333: Pathiam System with Iscan for P53 and KI-67 (2010), 7 descendants of its own
- K111755: Virtuoso System for Ihc KI-67 (30-9) (2012), 2 descendants of its own
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5) (2011), 2 descendants of its own
- K111872: Virtuoso System for Ihc P53 (DO-7) (2012), 1 descendant of its own
- K140957: Genasis Hipath Ihc Family (2015), 0 descendants of its own

## 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 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 KJ-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.

Source page: https://510kreport.com/device/K053520
Methodology: https://510kreport.com/methodology