Cleared Special

K053308 - ABX MICROS CRP 200, OPTION IM

K053308 is an FDA 510(k) clearance for ABX MICROS CRP 200, manufactured by Horiba Abx. The device is a Class 2 Hematology device with product code GKZ cleared through the Special 510(k) pathway after a 31-day FDA review.

K053308 · Horiba Abx · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
31d
Days
Class 2
Risk

K053308 is an FDA 510(k) clearance for the ABX MICROS CRP 200, OPTION IM. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on December 29, 2005 after a review of 31 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 - K053308

510(k) Number K053308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2005
Decision Date December 29, 2005
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
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
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K053308 · ABX MICROS CRP 200, OPTION IM
Download PDF FDA Summary Horiba Abx