Cleared Dual Track

K172604 - XW-100 Automated Hematology Analyzer fo...

K172604 is the FDA 510(k) clearance for XW-100 Automated Hematology Analyzer fo... by Sysmex America, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Dual Track 510(k) pathway after a 68-day FDA review.

K172604 · Sysmex America, Inc. · Hematology device
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Nov 2017
Decision
68d
Days
Class 2
Risk

K172604 is an FDA 510(k) clearance for the XW-100 Automated Hematology Analyzer for CLIA Waived Use. 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 6, 2017 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sysmex America, Inc. devices

Submission Details

510(k) Number K172604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2017
Decision Date November 06, 2017
Days to Decision 68 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
45d faster than avg
Panel avg: 113d · This submission: 68d
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

All 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K172604.
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