Not Cleared Direct

DEN220090 - EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748) (FDA 510(k) Clearance)

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220090 · Stemcell Technologies Canada, Inc. · Pathology device
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Nov 2023
Decision
329d
Days
Class 2
Risk

DEN220090 is an FDA 510(k) submission (not cleared) for the EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748). Classified as Hematopoietic Cell Enrichment Kit (product code QYO), Class II - Special Controls.

Submitted by Stemcell Technologies Canada, Inc. (Vancouver, CA). The FDA issued a Not Cleared (DENG) decision on November 6, 2023 after a review of 329 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6120 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 329 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Stemcell Technologies Canada, Inc. devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 77d · This submission: 329d
Pathway characteristics

Device Classification

Product Code QYO Hematopoietic Cell Enrichment Kit
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.