# K050589: Ret-HE Parameter on the Sysmex Model XE-2100 Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: May 4, 2005 after 57 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) CHr parameter on the Bayer Advia 120 Hematology System: named in the summary without a submission number

## Most influential descendants
- K081890: Sysmex XT-Series IG Parameter,Sysmex XT-Series Ret-HE Parameter (2008), 0 descendants of its own

## Indications for use
The RET-He parameter on the Sysmex® XE-2100, Automated Hematology Analyzer, determines the hemoglobin of reticulocytes for in vitro diagnostic use-in clinical laboratories.

Source page: https://510kreport.com/device/K050589
Methodology: https://510kreport.com/methodology