# K121033: Virtuoso System for Ihc KI-67 (30-9)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Sep 6, 2013 after 519 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: 3 generations back to K053520 (2006). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111755: Virtuoso System for Ihc KI-67 (30-9), Ventana Medical Systems, Inc. (2012) Summary page 1.

## 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 IHC Ki-07 (30-9) Digital Read and Image Analysis applications are intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of KI-67 protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. KiO7 results are indicated for use in assessing the proliferative activity of normal and neoplastic breast tissue. When used with Ventana Medical Systems, Inc. CONFIRM TM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody Assay, it is indicated for use as an aid in the assessment of KI-67 status in breast cancer patients (but is not the sole basis for treatment). Note: The IHC Ki-67 (30-9) 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 Ki-67 protein. The pathologist should verify agreement with the Image Analysis software application scare. The accuracy of the test results depends on the quality of the immunohlstochemlcal staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM h anti- Ki-67 (30-9) Rabbit Monoclonal Primary Antibody assay used to assure the validity of the Virtuoso System for 11-4 Ki-67 Digital Read and Image Analysis scores. The actual correlation of CONFIRM" anti-KI-67 (30-9) Rabbit Monoclonal Primary Antibody to clinical outcome has not been established.

Source page: https://510kreport.com/device/K121033
Methodology: https://510kreport.com/methodology