Cleared Special

K024002 - PENTRA 80

K024002 is an FDA 510(k) clearance for PENTRA 80, 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 30-day FDA review.

K024002 · Abx Diagnostics · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
30d
Days
Class 2
Risk

K024002 is an FDA 510(k) clearance for the PENTRA 80. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abx Diagnostics (Montpellier, FR). The FDA issued a Cleared decision on January 3, 2003 after a review of 30 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 - K024002

510(k) Number K024002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date January 03, 2003
Days to Decision 30 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
83d faster than avg
Panel avg: 113d · This submission: 30d
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 K024002.
MICROS 60
K030799 · Abx Diagnostics · Apr 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
K030408 · Beckman Coulter, Inc. · Mar 2003
MODIFICATION TO PENTRA 60 AND PENTRA 60C+
K030144 · Abx Diagnostics · Jan 2003
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
K022668 · Bayer Diagnostics Corp. · Oct 2002
IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
K022528 · Iq Corp. · Sep 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · Beckman Coulter, Inc. · Jul 2002
K024002 · PENTRA 80
Download PDF FDA Summary Abx Diagnostics