(a) Identification. 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.
(b) Classification. Class II (special controls). The special control is FDA's guideline entitled ``Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis.'' For availability of the document, see Sec. 866.1(e). [79 FR 56010, Sept. 18, 2014]