Cardiac Allograft Gene Expression Profiling Test System
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.