# K143577: XW-100 Automated Hematology Analyzer, XW QC CHECK

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Oct 12, 2015 after 299 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: 1 generation back to K852992 (1985). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852992: Para Check (Aka Eight Check-C), Streck Laboratories, Inc. (1985) Summary page 6.
- (no number) Sysmex pocH-100i Automated Hematology Analyzer: named in the summary without a submission number

## Most influential descendants
- K172604: XW-100 Automated Hematology  Analyzer for CLIA Waived Use (2017), 1 descendant of its own
- K210346: Sysmex XW-100 Automated Hematology Analyzer (2022), 0 descendants of its own

## Indications for use
The Sysmex XW-100™ is a quantitative automated hematology analyzer intended for in vitro diagnostic point of care use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV. It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or critically ill patients. XW QC CHECK is a stabilized whole blood matrix designed for statistical process control of the Sysmex XW-100 automated hematology analyzer. It is not intended for calibration of the analyzer. Assayed parameters include WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV.

Source page: https://510kreport.com/device/K143577
Methodology: https://510kreport.com/methodology