Cleared Traditional

K991839 - ABX PENTRA 120 RETIC AUTOMATED HEMATOLO...

K991839 is the FDA 510(k) clearance for ABX PENTRA 120 RETIC AUTOMATED HEMATOLO... by Abx Diagnostics. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K991839 · Abx Diagnostics · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
75d
Days
Class 2
Risk

K991839 is an FDA 510(k) clearance for the ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abx Diagnostics (Huntington Beach, US). The FDA issued a Cleared decision on August 11, 1999 after a review of 75 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 K991839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date August 11, 1999
Days to Decision 75 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
38d faster than avg
Panel avg: 113d · This submission: 75d
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 K991839.
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
CELL-DYN 1200 SYSTEM
K991142 · Abbott Laboratories · Jun 1999
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1
K991402 · Dako Corp. · Jun 1999