# K071652: Hemocue WBC System

- Pathway: 510(k) (Traditional)
- Applicant: Hemocue AB
- Decided: Oct 25, 2007 after 129 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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 K060656 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060656: Sysmex Automated Hematology Analyzer Models XS Series, Sysmex America, Inc. (2006) Summary page 1.
- (no number) Manual light microscopic WBC method: named in the summary without a submission number

## Indications for use
The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.

Source page: https://510kreport.com/device/K071652
Methodology: https://510kreport.com/methodology