Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1163](/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1163) → OJQ — Cardiac Allograft Gene Expression Profiling Test System

# OJQ · Cardiac Allograft Gene Expression Profiling Test System

_Cardiovascular · 21 CFR 862.1163 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems/OJQ

## Overview

- **Product Code:** OJQ
- **Device Name:** Cardiac Allograft Gene Expression Profiling Test System
- **Regulation:** [21 CFR 862.1163](/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1163)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K221640](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems/OJQ/K221640.md) | AlloMap Heart Molecular Expression Testing | Caredx, Inc. | Sep 13, 2023 | SESE |
| [DEN080007](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems/OJQ/DEN080007.md) | ALLOMAP MOLECULAR EXPRESSION TESTING | Xdx | Aug 26, 2008 | DENG |

## Top Applicants

- Caredx, Inc. — 1 clearance
- Xdx — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems/OJQ](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94clinical-chemistry-test-systems/OJQ)

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