21 CFR 862.1163 — Cardiac Allograft Gene Expression Profiling Test System
Cardiovascular (CV) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1163
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OJQ | Cardiac Allograft Gene Expression Profiling Test System | 2 | 2 |
Special Controls
OJQ — Cardiac Allograft Gene Expression Profiling Test System
*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.
eCFR
OJQ — Cardiac Allograft Gene Expression Profiling Test System
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.
Ecfr Llm
