OJQ — Cardiac Allograft Gene Expression Profiling Test System Class II
FDA product code OJQ covers "Cardiac Allograft Gene Expression Profiling Test System", a Class II medical device regulated under 21 CFR 862.1163. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.