# Cardiac Allograft Gene Expression Profiling Test System
> **Product code: OJQ** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 862.1163
## Classification
- **FDA Product Code:** OJQ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1163
- **Review panel:** CH
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (acr) at the time of testing in conjunction with standard clinical assessment.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OJQ)
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