Cleared Special

K003677 - ABX PENTRA 60C+ HEMATOLOGY ANALYZER

K003677 is an FDA 510(k) clearance for ABX PENTRA 60C+ HEMATOLOGY ANALYZER, manufactured by Abx Diagnostics. The device is a Class 2 Hematology device with product code GKZ cleared through the Special 510(k) pathway after a 27-day FDA review.

K003677 · Abx Diagnostics · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
27d
Days
Class 2
Risk

K003677 is an FDA 510(k) clearance for the ABX PENTRA 60C+ HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abx Diagnostics (Irvine, US). The FDA issued a Cleared decision on December 26, 2000 after a review of 27 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 - K003677

510(k) Number K003677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2000
Decision Date December 26, 2000
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
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 K003677.
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
K010953 · Abbott Laboratories · Jun 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
K010765 · Beckman Coulter, Inc. · Apr 2001
ADVIA 120 HEMATOLOGY
K003796 · Bayer Corp. · Feb 2001
ABX MICROS CRP
K002646 · Abx Diagnostics · Oct 2000
STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
K000611 · Bd Biosciences · May 2000
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
K000897 · Bd Biosciences · May 2000
K003677 · ABX PENTRA 60C+ HEMATOLOGY ANALYZER
Download PDF FDA Summary Abx Diagnostics