OJQ — Cardiac Allograft Gene Expression Profiling Test System Class II

FDA Device Classification

Classification Details

Product Code
OJQ
Device Class
Class II
Regulation Number
862.1163
Submission Type
Review Panel
CH
Medical Specialty
Cardiovascular
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221640caredxAlloMap Heart Molecular Expression TestingSeptember 13, 2023
DEN080007xdxALLOMAP MOLECULAR EXPRESSION TESTINGAugust 26, 2008