Opportunity
Federal Register #2026-20725
FDA Class II classification and special controls for hematopoietic cell enrichment kits
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 09, 2026
Identifier
2026-20725
The FDA finalized device classifications and special controls for diagnostic systems; this notice does not announce a purchase. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA), Center for Devices and Radiological Health. - OEM: STEMCELL Technologies Canada Inc. requested De Novo classification for its EasySep Human Bone Marrow CD138 Positive Selection Kit. - Device covered: A Class II in vitro diagnostic hematopoietic cell enrichment kit that uses immunomagnetic bead-based selection to enrich cells from human whole blood and/or bone marrow for diagnostic assays. No quantity or part number is stated. - Special controls: Requirements address eligible specimen-collection devices, intended-use statements, labeling, and design verification and validation, including recovery, limit-of-detection, reproducibility, specificity, specimen-stability, reagent-stability, and shipping-stability studies. - Separate classification order noted: A system for detecting nucleic acid from non-viral microorganisms causing sexually transmitted infections using home-collected specimens is also identified, but this excerpt provides no detailed requirements or manufacturer. - Procurement context: No products or services are being solicited for purchase, and no contract value or performance period is stated.
Description
The FDA is classifying the hematopoietic cell enrichment kit as a class II device subject to special controls. The kit is an in vitro diagnostic device for selecting and enriching specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies, for use with diagnostic assays as part of the pre-analytical workflow. The final order establishes special controls addressing sample collection, intended-use labeling, device labeling, and design verification and validation. The order is effective October 9, 2026, and the classification was applicable on November 6, 2023.