Cleared Traditional

ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (K170353) - FDA 510(k) Clearance

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

K170353 · HORIBA ABX SAS · Hematology device
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Nov 2017
Decision
271d
Days
Class 2
Risk

K170353 is an FDA 510(k) clearance for the ABX MICROS ES 60 OT and 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 November 1, 2017 after a review of 271 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 K170353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2017
Decision Date November 01, 2017
Days to Decision 271 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
158d slower than avg
Panel avg: 113d · This submission: 271d
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 K170353.
HemoScreen Hematology Analyzer
K180020 · Pixcell Medical Technologies, Ltd. · Oct 2018
cobas m 511 integrated hematology analyzer
K171655 · Roche Diagnostics Hematology, Inc. · Mar 2018
XW-100 Automated Hematology Analyzer for CLIA Waived Use
K172604 · Sysmex America, Inc. · Nov 2017
ADVIA 2120i, ADVIA 2120
K162977 · Siemens Healthcare Diagnostics · Aug 2017
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