Device |
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 |
Division of Immunology and Hematology Devices
(DIHD)
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
|