| Device |
hematopoietic cell enrichment kit |
| Definition |
A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection. It is intended for use with diagnostic assays as part of the pre-analytical workflow. |
| Physical State |
May include immunomagnetic beads, reagents, and magnet used to enrich and isolate specific antigen presenting B-cells. The device may include a use as a component used for further downstream assays. The standalone enrichment device is not intended for diagnostic, prognostic, or monitoring use with cells, including as an aid in any disease management and/or treatment decisions. The device is not intended to isolate cells to be used for patient treatment. |
| Technical Method |
Cells of interest from sample sources, including blood and bone marrow, are targeted with antibody complexes bound to magnetic bead particles for negative or positive selection using a magnet to isolate the selected cells. |
| Target Area |
Human clinical specimens, including bone marrow aspirates and peripheral blood clinical specimen |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Molecular Genetics |
|---|
| Product Code | QYO |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6120
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
