# K051199: Ipf (Immature Platelet Fraction) Parameter on the Sysmex Model XE-2100 Automated Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Aug 8, 2005 after 90 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) reticulated platelet on the FACSCalibur flow cytometric method: named in the summary without a submission number

## Indications for use
The IPF% (Immature Platelet Fraction) on the Sysmex® XE-2100 for in Vitro diagnostics is used to enumerate the immature platelet fraction.

Source page: https://510kreport.com/device/K051199
Methodology: https://510kreport.com/methodology