A Flow Cytometric Test For Hematopoietic Neoplasms is a device that consists of reagents for immunophenotyping of human cells in relation to the level of expression, antigen density, and distribution of specific cellular markers.

Intended Use of Flow Cytometric Test System for Hematopoietic Neoplasms

These reagents are used as an aid in the differential diagnosis or monitoring of hematologically abnormal patients having or suspected of having hematopoietic neoplasms. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. The indications for use must indicate the clinical hematopoietic neoplasms for which the assay was designed and validated, for example, chronic leukaemia or lymphoma

Intended Use

These reagents aid in the diagnosis and monitoring of hematopoietic neoplasms in patients with suspected hematologic abnormalities. Results should be interpreted by a qualified professional alongside clinical and laboratory findings. The intended use must specify the validated conditions, such as chronic leukaemia or lymphoma.

Device Description

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).

The physical composition of this device includes monoclonal and polyclonal antibody cocktails arranged in panels, along with accessory reagents, software, and analytical beads designed for data acquisition and analysis.

Its technical methodology involves the use of these reagents to generate multiparameter, qualitative results for assessing Cluster of Differentiation (CD) parameters, aiding in immune profiling and diagnostic evaluations.

The target specimen types for this device include whole blood, bone marrow, and lymph node samples, making it suitable for hematological and immunological analyses.

• Linearity
• Precision (Reproducibility and Repeatability)
• Assay carryover
• Reagent carryover
• Specimen carryover
• Accuracy
• Traceability
• Sensitivity and Specificity
• Limit of Detection (LoD), Limit of Quantitation (LoQ), and Limit of Blank (LoB)
• Shelf-life stability
• Transportation stability
• Method comparison

Clinical Testing:

No Guidance available for 510k submission