Cleared Traditional

ABX MICROS ES 60 CT (K141161) - FDA 510(k) Clearance

Also marketed or referenced as:
(OPEN TUBE MODEL), (CLOSE TUBE MODEL)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141161 · HORIBA ABX SAS · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
229d
Days
Class 2
Risk

K141161 is an FDA 510(k) clearance for the ABX MICROS ES 60 CT. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on December 20, 2014 after a review of 229 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all HORIBA ABX SAS devices

Submission Details

510(k) Number K141161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2014
Decision Date December 20, 2014
Days to Decision 229 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
116d slower than avg
Panel avg: 113d · This submission: 229d
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 125
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K141161.
Sysmex XN-L Automated Hematology Analyzer
K160538 · Sysmex America, Inc. · Dec 2016
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
K162414 · Beckman Coulter, Inc. · Nov 2016
XW-100 Automated Hematology Analyzer, XW QC CHECK
K143577 · Sysmex America, Inc. · Oct 2015
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
K140911 · Beckman Coulter, Inc. · Sep 2014
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K120771 · Beckman Coulter, Inc. · Mar 2013
CELL-DYN EMERALD 22 SYSTEM
K110381 · Abbott Laboratories · Dec 2011