# K081890: Sysmex XT-Series IG Parameter,Sysmex XT-Series Ret-HE Parameter

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Oct 10, 2008 after 100 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 K032039 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032039: Immature Granulocyte (IG) Parameter on the Sysmex Model XE-2100 Automated Hematology Analyzer, Sysmex America, Inc. (2003) Summary page 1.
- K050589: Ret-HE Parameter on the Sysmex Model XE-2100 Automated Hematology Analyzer, Sysmex America, Inc. (2005) Summary page 1.

## Indications for use
The IG parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, is intended for in vitro diagnostic use to classify and count immature granulocyte cells in EDTA anti-coagulated blood. The RET-He parameter on the Sysmex® XT-Series, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use in EDTA anti-coagulated blood.

Source page: https://510kreport.com/device/K081890
Methodology: https://510kreport.com/methodology