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U.S. Department of Health and Human Services

Product Classification

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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 CodeOVG
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
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible