Cleared Traditional

K151133 - PENTRA XLR

K151133 is an FDA 510(k) clearance for PENTRA XLR, 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 225-day FDA review.

K151133 · HORIBA ABX SAS · Hematology device
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Dec 2015
Decision
225d
Days
Class 2
Risk

K151133 is an FDA 510(k) clearance for the PENTRA XLR. 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 9, 2015 after a review of 225 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 - K151133

510(k) Number K151133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2015
Decision Date December 09, 2015
Days to Decision 225 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 113d · This submission: 225d
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 318
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K151133.
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
BC-5390 Auto Hematology Analyzer
K160429 · Mindray Bio-Medical Electronics Co., Ltd. · Sep 2016
XW-100 Automated Hematology Analyzer, XW QC CHECK
K143577 · Sysmex America, Inc. · Oct 2015
BC-3600 Auto Hematology Analyzer
K143348 · Mindray Bio-Medical Electronics Co., Ltd. · Aug 2015
ABX MICROS ES 60 CT
K141161 · HORIBA ABX SAS · Dec 2014