OJQ · Cardiac Allograft Gene Expression Profiling Test System
Cardiovascular · 21 CFR 862.1163 · Class 2
Overview
| Product Code | OJQ |
|---|---|
| Device Name | Cardiac Allograft Gene Expression Profiling Test System |
| Regulation | 21 CFR 862.1163 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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.
Special Controls
*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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221640 | AlloMap Heart Molecular Expression Testing | Caredx, Inc. | Sep 13, 2023 | SESE |
| DEN080007 | ALLOMAP MOLECULAR EXPRESSION TESTING | Xdx | Aug 26, 2008 | DENG |
Top Applicants
- Xdx — 1 clearance
- Caredx, Inc. — 1 clearance
