Intended Use Statement

The Duet™ System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aid to the pathologist in the detection, classification and counting of cells of interests 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.

In the EU and Canada, the Duet™ System has not been validated for a specific clinical application and/or to be used in combination with dedicated reagents and materials. It is the end user responsibility to validate the use of the Duet system in combination with commercial reagents and materials for a specific clinical application.