Issue Date: 09/18/2014
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health
This document was developed as a special controls guideline to support the classification of a tryptase test system into class II (special controls). A tryptase test system is a device that aids in the diagnosis of systemic mastocytosis. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of patients with a suspicion of systemic mastocytosis in conjunction with other clinical and laboratory findings.