Cleared Special

K032013 - COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER

K032013 is an FDA 510(k) clearance for COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Special 510(k) pathway after a 24-day FDA review.

K032013 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
24d
Days
Class 2
Risk

K032013 is an FDA 510(k) clearance for the COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 24, 2003 after a review of 24 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.

FDA 510(k) Submission Details - K032013

510(k) Number K032013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2003
Decision Date July 24, 2003
Days to Decision 24 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
89d faster than avg
Panel avg: 113d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

GKZ Device Classification - Class 2, Special Controls

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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K032013.
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K032013 · COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
Download PDF FDA Summary Beckman Coulter, Inc.