Intended Use Statement

The Duet™ system is an automated scanning microscope and imaging and analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist to review and interpret digital images of slides by detecting, classifying and counting of cells of interest based on color, intensity, size, pattern and shape.

It is intended to detect and quantify cells stained by various Bright Field staining methods (including Giemsa, Pap-stain, H&E-stain, Immunohistochemistry), and by various fluorescent methods (including immune-fluorescent markers and FISH). The system can be used for both cell suspension samples and tissue samples. This device should be used by authorized and trained laboratory personnel only.

Specifically, for the above sample types, the clinical utility of Duet system is to quantify, enhance, and digitally segment pathology images to improve visibility of features for pathologists, who review and interpret the images, and approve results before use in diagnostic pathways.

In the EU and Canada, it is the end user’s responsibility to validate the use of the Duet system in combination with commercial reagents and materials for a specific clinical application.