Cleared Traditional

K141161 - ABX MICROS ES 60 CT

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

K141161 is an FDA 510(k) clearance for ABX MICROS ES 60 CT, manufactured by HORIBA ABX SAS. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 229-day FDA review.

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

FDA 510(k) Submission Details - K141161

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.

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 227
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
SYSMEX XN SERIES
K141681 · Sysmex America, Inc. · Dec 2014
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