---
kind: "section"
citation: "21 C.F.R. § 862.3840"
title: "21"
number: "862.3840"
heading: "Sirolimus test system."
url: "https://uscodex.org/cfr/21/862.3840"
---

# §862.3840. Sirolimus test system.

- (a) **Identification.** A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.
- (b) **Classification.** Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See [§ 862.1(d)](/cfr/21/862.1.md?p=d) for the availability of this guidance document.

## Notes

### Amendments

[69 FR 58259, Sept. 30, 2004]

### Authority

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

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[69 FR 58259, Sept. 30, 2004]