| Device |
whole blood pre-treatment t-cell enrichment reagent |
| Definition |
The reagent is for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25°C). |
| Physical State |
Liquid reagent |
| Technical Method |
The reagent contains bispecific monoclonal antibodies which are directed against cell surface markers on selected white blood cells and glycophorin A on red blood cells. The reagent cross-links the selected white blood cells with the red blood cells, which increases the density of the selected cells. When a density gradient is applied during the blood cell extraction process, the selected white blood cells remain separated into the red blood cell layer away from the PBMC layer and non-selected cells, including T cells and antigen presenting cells contained in the PBMC layer. |
| Target Area |
Whole blood samples |
| Review Panel |
Microbiology |
|---|
| Product Code | ORL |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| 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 |
