| Device |
cardiac allograft gene expression profiling test system |
| Regulation Description |
Cardiac allograft gene expression profiling test system. |
| 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. |
| Physical State |
laboratory based test |
| Technical Method |
quantitative real-time polymerase chain reaction technology (qRT-PCR) |
| Target Area |
cardiac allograft |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | OJQ |
|---|
| Premarket Review |
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.1163
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
