# K210346: Sysmex XW-100 Automated Hematology Analyzer

- Pathway: 510(k) (Dual Track)
- Applicant: Sysmex America, Inc.
- Decided: Nov 8, 2022 after 638 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K852992 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172604: XW-100 Automated Hematology  Analyzer for CLIA Waived Use, Sysmex America, Inc. (2017) Summary page 4.

## Indications for use
The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.

Source page: https://510kreport.com/device/K210346
Methodology: https://510kreport.com/methodology