# DEN220090: EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)

- Pathway: De Novo (Direct)
- Applicant: Stemcell Technologies Canada, Inc.
- Decided: Nov 6, 2023 after 329 days
- Product code: QYO (Hematopoietic Cell Enrichment Kit )
- Device class: 2
- Regulation: 21 CFR 866.6120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
EasySep Human Bone Marrow CD138 Positive Selection Kit is an in vitro diagnostic device intended to enrich CD138+ cells from bone marrow collected from patients diagnosed with multiple myeloma. The CD138+ cells are enriched by immunomagnetic positive selection for use in validated downstream assays. The end-user is responsible for validation of this kit for use with the assay. For in vitro diagnostic use by laboratory professionals.

Source page: https://510kreport.com/device/DEN220090
Methodology: https://510kreport.com/methodology