Cleared Special

CELL-DYN Emerald 22 AL System (K190294) - FDA 510(k) Clearance

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

K190294 · Abbott Laboratories · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
32d
Days
Class 2
Risk

K190294 is an FDA 510(k) clearance for the CELL-DYN Emerald 22 AL System. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on March 15, 2019 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Laboratories devices

Submission Details

510(k) Number K190294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2019
Decision Date March 15, 2019
Days to Decision 32 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 Hematology devices follow this clearance model.

Regulatory Peers - GKZ Counter, Differential Cell

All 124
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K190294.
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K181288 · Athelas, Inc. · Nov 2018