# K130515: Virtuoso System for Ihc ER (Spi)

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Nov 22, 2013 after 268 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K140957: Genasis Hipath Ihc Family (2015), 0 descendants of its own
- K140465: Virtuoso System for Ihc ER (SP1) with Benchmark Ultra Stainer (2014), 0 descendants of its own

## Indications for use
The Virtuoso systemi provides automated digital slide creation. management; analysis, and viewing. It is inteded for in vitro diagnostic use as an aid to the pathologist in the display, detection, counating, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. 'Mhe Virtuoso" System for NHC ER (SF 1) is for digital read and image analysis applications. This particular Virtuoso systemn is intended for use as an aid to the pathologist in the detection and sani-quantilstive measurement of estrogen receptor (ER) protein i farmalii-fized, paraflln-embcdded neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM" anti- Estrogen Receptor (ER) (SF1) Rabbit Monoclonal Primary Antibody assay. The CONFIRM" anti- ER (SF1) 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 ERt (SPI) Digital Read and Image Analysis applications are adjunctive computer-asisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cance specimens stained for the presence of ER protein. The pathologist should verfy agreement with the Image Analysis software application sore. Thec accuracy of the test results depends on the quality of the iniuunhistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONPIRM" anti- Estrogen Receptor (ER) (SP3) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoo System for IHC ER Digital Read and Image Analysis scores. The actual correlation of CONFIRM anti-Estrogen Receptor (ER)(SPI) Rabbit Monoclonal Antibody to clinical outcome has not been established.

Source page: https://510kreport.com/device/K130515
Methodology: https://510kreport.com/methodology