DEN220090 is an FDA 510(k) submission for the EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748). This device is classified as a Hematopoietic Cell Enrichment Kit (Class II - Special Controls, product code QYO).
Submitted by Stemcell Technologies Canada, Inc. (Vancouver, CA). The FDA issued a Not Cleared (DENG) decision on November 6, 2023.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6120. 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..
| 510(k) Number | DEN220090 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 12, 2022 |
| Decision Date | November 06, 2023 |
| Days to Decision | 329 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | - |
| Product Code | QYO - Hematopoietic Cell Enrichment Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6120 |
| 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. |