FDA codifies Class II hematopoietic cell enrichment kit category; De Novo decision dates to 2023
Summary
FDA codified hematopoietic cell enrichment kits as Class II under 21 CFR 866.6120 on 9 October 2026, following the original 2023 De Novo classification. This is a pre-analytical device category, not a new MRD assay authorization.
Source Date
October 9, 2026
Source checked
October 10, 2026
Event Type
Regulatory codification
Event Date
October 9, 2026
Geography
United States
Commercial Regulatory Status
Class II with special controls; 2023 De Novo classification codified in 2026.
Related CFCM Topics
Validation; MRD; pre-analytics; Regulatory Watch
Category
Regulatory
Primary source
Read the source →Facts supported by cited sources
What changed
The final order effective 9 October 2026 adds 21 CFR 866.6120. The underlying EasySep Human Bone Marrow CD138 Positive Selection Kit classification dates to 6 November 2023 (DEN220090).
The category covers immunomagnetic enrichment before diagnostic testing. Special controls address specimen handling, enrichment performance, stability and downstream assay compatibility. The category remains subject to 510(k) requirements.
Claims Requiring Caution
This is codification of an earlier classification, not a new 2026 approval. The kit is not intended for cell enumeration and does not itself report a health condition. No flow-cytometric MRD assay authorization is inferred.
Why It Matters
Why it matters for CFCM
Enrichment changes sample composition. Laboratories should validate the complete enrichment-plus-assay workflow and document the denominator used for reporting; enriched fractions cannot simply be interpreted as an unselected marrow measurement.
An announcement is not proof of availability or authorisation. Interpret status within the stated jurisdiction and evidence boundary.
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