# K111869: Virtuoso System for Ihc PR (IE2)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Mar 5, 2012 after 248 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
Longest line of descent: 2 generations back to K033200 (2004). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073677: Scanscope XT System, Aperio Technologies (2008) Summary page 1.

## Most influential descendants
- K122143: Virtuoso System for Ihc PR (1E2) Benchmark Ultra Stainer (2013), 1 descendant of its own
- K142965: Virtuoso System for IHC PR (1E2) using iScan HT (2015), 0 descendants of its own
- K140957: Genasis Hipath Ihc Family (2015), 0 descendants of its own
- K121516: Virtuoso System for Ihc HER2 (4B5) (2013), 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 VirtuosoTM System for IHC PR (1E2) 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 progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment). Note: The IHC PR (1E2) 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 PR 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 CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM anti-PR antibody to clinical outcome has not been established.

Source page: https://510kreport.com/device/K111869
Methodology: https://510kreport.com/methodology