| Device |
flow cytometric test system for hematopoietic neoplasms |
| Regulation Description |
Flow cytometric test system for hematopoietic neoplasms. |
| Definition |
Reagents intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on a flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin's lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN) |
| Physical State |
Monoclonal and polyclonal antibody cocktails in panels, accessory reagents including software and beads used for analysis and acquisition of data. |
| Technical Method |
These reagents provide multiparameter, qualitative results for the Cluster of Differentiation (CD) parameters. |
| Target Area |
Whole blood, bone marrow, and lymph node specimens. |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Hematology |
|---|
| Product Code | PWD |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.7010
|
|---|
| 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
|
Accredited Persons
|
