# K020496: HPC (Hematopoietic Progenitor Cell) Parameter on the Imi Channel of the Sysmex SE-9500 and XE-2100, Automated Hematology

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corporation of America
- Decided: Apr 12, 2002 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.
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) Colony Forming Unit (CFU): named in the summary without a submission number
- (no number) Total Nucleated Count (TNC): named in the summary without a submission number

## Indications for use
The HPC (hematopoietic progenitor cell) parameter of the IMI Channel on the Sysmex® SE-9500 and XE-2100 for in Vitro Diagnostics is used as a screen for the optimal presence of hematopoietic progenitor cells in peripheral blood and cord blood samples.

Source page: https://510kreport.com/device/K020496
Methodology: https://510kreport.com/methodology