Virtuoso System for IHC PR (1E2) Benchmark Ultra Stainer

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K122143 ↗

FDA Product Code

NQN

Device Class

Class II

Regulation

21 CFR Part 864.1860

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical purpose of the Virtuoso System for IHC PR (1E2) Benchmark Ultra Stainer in breast cancer diagnostics?

  The Virtuoso System is designed to automate the analysis of digital slides created by the Benchmark ULTRA™ stainer, specifically for quantifying nuclear intensity and percent positivity of progesterone receptor (PR) protein expression in tissue samples. This aids pathologists in breast cancer diagnostics by providing objective, digital measurements of PR expression, which helps inform treatment decisions.

• Is the Virtuoso System intended for single-use or repeated use in a laboratory setting, and how should it be maintained?

  The Virtuoso System is a reusable medical device, meaning it is built for repeated use in a laboratory environment. Since it is non-sterile, proper laboratory storage and maintenance protocols must be followed to ensure consistent performance and reliability. Regular cleaning and calibration, as outlined in the manufacturer’s guidelines, are essential to sustain its functionality.

• What type of laboratory setting is this device intended for, and what role does it play alongside the Benchmark ULTRA™ stainer?

  The Virtuoso System is specifically intended for use in hematology pathology settings, where it serves as an accessory to the Ventana CONFIRM™ anti-PR (1E2) assay. It processes digital images generated by the Benchmark ULTRA™ stainer to analyze and quantify PR expression in tissue samples, providing automated, operator-intervention microscopy for more precise diagnostic results.

• How is the regulatory status of this device determined, and what does the product code (NQN) indicate?

  The Virtuoso System holds FDA 510(k) clearance (K122143), confirming it is classified as a Class II medical device under the U.S. regulatory framework. The product code NQN categorizes it under the Nuclear Intensity & Percent Positivity classification, reflecting its role in automated image analysis for diagnostic purposes. This classification is tied to its intended use in hematology pathology.

• What key features distinguish this system from traditional manual microscopy in PR testing?

  Unlike traditional manual microscopy, the Virtuoso System automates the analysis of digital slides, reducing human variability in assessing nuclear intensity and percent positivity of PR expression. It integrates with the Benchmark ULTRA™ stainer to generate standardized, quantifiable results, improving efficiency and consistency in breast cancer diagnostics while minimizing subjective interpretation by pathologists.