# K090013: Chempaq XBC Analyzer

- Pathway: 510(k) (Special)
- Applicant: Chempaq A/S
- Decided: Apr 21, 2009 after 109 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) Chempaq XBC Analyzer: named in the summary without a submission number

## Indications for use
The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("HGB") in whole-blood samples (finger stick or venous sample). The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.

Source page: https://510kreport.com/device/K090013
Methodology: https://510kreport.com/methodology