# K992849: QBC Star Centrifugal Hematology System

- Pathway: 510(k) (Special)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Sep 23, 1999 after 30 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) QBC™ AUTOREAD™ Plus Hematology System: named in the summary without a submission number

## Indications for use
The QBC STAR Centrifugal Hematology System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, MCHC (Mean Corpuscular Hemoglobin Concentration, platelet count, white blood cell count, granulocyte count (% and number) and lymphocyte/monocyte count (% and number).

Source page: https://510kreport.com/device/K992849
Methodology: https://510kreport.com/methodology