---
kind: "section"
citation: "21 C.F.R. § 862.1163"
title: "21"
number: "862.1163"
heading: "Cardiac allograft gene expression profiling test system."
url: "https://uscodex.org/cfr/21/862.1163"
---

# §862.1163. Cardiac allograft gene expression profiling test system.

- (a) **Identification.** A cardiac allograft gene expression profiling test system is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern, classifier, index, score) to aid in the identification of a low probability of acute cellular rejection (ACR) in heart transplant recipients with stable allograft function.
- (b) **Classification.** Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems.” See [§ 862.1(d)](/cfr/21/862.1.md?p=d) for the availability of this guidance document.

## Notes

### Amendments

[74 FR 53885, Oct. 21, 2009]

### 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

[74 FR 53885, Oct. 21, 2009]