# K111543: Virtuoso (TM) System for Ihc HER2 (4B5)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Oct 12, 2011 after 132 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
Longest line of descent: 2 generations back to K032113 (2003). 6 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K080564: Scanscope XT System, Aperio Technologies (2009). Our reading of the summary gave K080654, FDA’s number for Pajunk's Kit for Balloon Aided Laparoscopy (PAJUNK GmbH Medizintechnologie). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Aperio ScanScope® XT System”. Summary page 4.
- K092333: Pathiam System with Iscan for P53 and KI-67, Bioimagene, Inc. (2010) Summary page 1.

## Most influential descendants
- K140957: Genasis Hipath Ihc Family (2015), 0 descendants of its own
- K131140: Omnyx Idp for HER2 Manual Application (2014), 0 descendants of its own

## Indications for use
The Virtuoso system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The Virtuoso™ System for IHC HER2 (4B35) is for digital read and image analysis applications. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. PATHWAY® anti-HER2/neu (4B35) Rabbit Monoclonal Primary Antibody. The PATHWAY® anti-HER2/neu (4B35) Rabbit Monoclonal Primary Antibody is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. NOTE: The IHC HER2 4B35 Digital Read and Image Analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of HER-2/neu receptor protein. The pathologist should verify agreement with the Image Analysis software application score. The accuracy of the test results depends on 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 PATHWAY® anti-HER-2/neu (4B35) Rabbit Monoclonal Primary Antibody assay used to assure the validity of the iScan System for IHC HER2 4B35 Digital Read and Image Analysis scores. The actual correlation of PATHWAY® anti-HER-2/neu (4B35) to clinical outcome has not been established.

Source page: https://510kreport.com/device/K111543
Methodology: https://510kreport.com/methodology