# 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.

[View original listing](https://www.federalregister.gov/documents/2026/10/09/2026-20725/medical-devices-immunology-and-microbiology-devices-classification-of-the-hematopoietic-cell)