Cleared Traditional

K143577 - XW-100 Automated Hematology Analyzer

K143577 is the FDA 510(k) clearance for XW-100 Automated Hematology Analyzer by Sysmex America, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K143577 · Sysmex America, Inc. · Hematology device
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Oct 2015
Decision
299d
Days
Class 2
Risk

K143577 is an FDA 510(k) clearance for the XW-100 Automated Hematology Analyzer, XW QC CHECK. 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 October 12, 2015 after a review of 299 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 Sysmex America, Inc. devices

Submission Details

510(k) Number K143577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2014
Decision Date October 12, 2015
Days to Decision 299 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
186d slower than avg
Panel avg: 113d · This submission: 299d
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 151
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