Cleared Traditional

K160538 - Sysmex XN-L Automated Hematology Analyzer

K160538 is an FDA 510(k) clearance for Sysmex XN-L Automated Hematology Analyzer, manufactured by Sysmex America, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K160538 · Sysmex America, Inc. · Hematology device
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Dec 2016
Decision
300d
Days
Class 2
Risk

K160538 is an FDA 510(k) clearance for the Sysmex XN-L Automated Hematology Analyzer. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Sysmex America, Inc. devices

FDA 510(k) Submission Details - K160538

510(k) Number K160538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2016
Decision Date December 22, 2016
Days to Decision 300 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
187d slower than avg
Panel avg: 113d · This submission: 300d
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 295
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