| Device |
magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml) |
| Definition |
For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis. |
| Physical State |
Anti-CD34 Antibody, Paramagnetic dextran beads, Tubing, Permanent Magnet, Software controlled pumps and valves, Buffers, Filters, Polymer Bags |
| Technical Method |
To select CD34+ hematopoietic progenitor cells from apheresis (HPC-A) labeled with antibody conjugated to paramagnetic beads using a semiautomated magnetic column. |
| Target Area |
Hematopoietic Progenitor Cells-apheresis (HPC-A) separated from whole blood. |
| Review Panel |
Hematology |
|---|
| Product Code | OVG |
|---|
| Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
