A guideline has been posted titled, "Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis." 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.
A tryptase test system is not indicated for a stand-alone diagnosis of mastocytosis or in the evaluation of anaphylaxis.
This guideline identifies measures that FDA believes will mitigate the risks to health associated with these devices and provide a reasonable assurance of safety and effectiveness. Firms submitting a 510(k) for a tryptase test system must either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness.
To view the guideline, please see: http://www.fda.gov/downloads/
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM414665. pdf