Ventana Medical Systems, Inc. (Ventana) Protease 1 is an endopeptidase (alkaline protease) of the serine protease family and cleaves antigens (proteins) in the tissue section, allowing primary antibodies to recognize and bind epitope(s). The reagent is intended for enzymatic digestion of sections of routine formalin-fixed, paraffin-embedded tissue on VENTANA automated slide stainers. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. This reagent is intended for in vitro diagnostic (IVD) use.