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The QCA device is intended to detect and classify cells of clinical interest based on recognition of cellular areas of particular color and chromatic intensity. In this software application, the QCA device is intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications. The QCA system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscopic slides of breast cancer specimens stained for the presence of estrogen (ER) nuclear receptor protein. The accuracy of the test result depends upon the quality of immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls to assure the validity of the QCA ER scores.

QCA is a standalone, automated intelligent cell assessment software device that analyzes digital images of cells of interest by pixel color attributes and pixel area detection algorithms. The software system utilizes a pathologist's own personal computer, light microscope, digital camera, printer, and Internet connection.