Cleared Traditional

K992511 - ABX PENTRA 60 HEMATOLOGY ANALYZER

K992511 is the FDA 510(k) clearance for ABX PENTRA 60 HEMATOLOGY ANALYZER by Abx Diagnostics. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K992511 · Abx Diagnostics · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
80d
Days
Class 2
Risk

K992511 is an FDA 510(k) clearance for the ABX PENTRA 60 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 October 15, 1999 after a review of 80 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abx Diagnostics devices

Submission Details

510(k) Number K992511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1999
Decision Date October 15, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 113d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K992511.
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
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · Coulter Corp. · Apr 2000
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · Abbott Laboratories · Sep 1999
QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
K992849 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION
K991605 · Abbott Laboratories · Jul 1999