Hematopoietic Cell Enrichment Kit

Page Type

Product Code

Definition

A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection. It is intended for use with diagnostic assays as part of the pre-analytical workflow.

Physical State

May include immunomagnetic beads, reagents, and magnet used to enrich and isolate specific antigen presenting B-cells. The device may include a use as a component used for further downstream assays. The standalone enrichment device is not intended for diagnostic, prognostic, or monitoring use with cells, including as an aid in any disease management and/or treatment decisions. The device is not intended to isolate cells to be used for patient treatment.

Technical Method

Cells of interest from sample sources, including blood and bone marrow, are targeted with antibody complexes bound to magnetic bead particles for negative or positive selection using a magnet to isolate the selected cells.

Target Area

Human clinical specimens, including bone marrow aspirates and peripheral blood clinical specimen

Regulation Medical Specialty

Immunology

Review Panel

Medical Genetics

Submission Type

510(K)

Device Classification

Class 2

Regulation Number

866.6120

GMP Exempt?

No

Summary Malfunction Reporting

Ineligible

Implanted Device

No

Life-Sustain/Support Device

No

Third Party Review

Not Third Party Eligible

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