# K061150: Sysmex Automated Hematology Analyzer, XT-Series

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Jul 6, 2006 after 72 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) XE-2100 Series Body Fluid Application: named in the summary without a submission number

## Indications for use
The Sysmex® XT-Series Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The XT- Series Body Fluid Application adds a quantitative, automated procedure for analyzing body fluids such as cerebrospinal fluid, serous fluid and synovial fluid to the XT- Series, providing enumeration of the WBCs and the RBCs.

Source page: https://510kreport.com/device/K061150
Methodology: https://510kreport.com/methodology