---
kind: "section"
citation: "21 C.F.R. § 866.5760"
title: "21"
number: "866.5760"
heading: "Tryptase test system."
url: "https://uscodex.org/cfr/21/866.5760"
---

# §866.5760. Tryptase test system.

- (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 [§ 866.1(e)](/cfr/21/866.1.md?p=e).

## Notes

### Amendments

[79 FR 56010, Sept. 18, 2014]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[79 FR 56010, Sept. 18, 2014]