Product Classification

• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock ventures
• global quality and regulatory services
• regulatory technology services, llc
• sgs north america