21 CFR § 862.1163 - Cardiac allograft gene expression profiling test system.

---
identifier: "/us/cfr/t21/s862.1163"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1163 - Cardiac allograft gene expression profiling test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1163"
section_name: "Cardiac allograft gene expression profiling test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 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) for the availability of this guidance document.

[74 FR 53885, Oct. 21, 2009]