Cleared Dual Track

K210346 - Sysmex XW-100 Automated Hematology Anal...

K210346 is the FDA 510(k) clearance for Sysmex XW-100 Automated Hematology Anal... by Sysmex America, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Dual Track 510(k) pathway after a 638-day FDA review.

K210346 · Sysmex America, Inc. · Hematology device
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Nov 2022
Decision
638d
Days
Class 2
Risk

K210346 is an FDA 510(k) clearance for the Sysmex XW-100 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 November 8, 2022 after a review of 638 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Sysmex America, Inc. devices

Submission Details

510(k) Number K210346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2021
Decision Date November 08, 2022
Days to Decision 638 days
Submission Type Dual Track
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
525d slower than avg
Panel avg: 113d · This submission: 638d
Pathway characteristics

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

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