# K960827: QBC Accutube (423406)/QBC Autoread (424571)

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Diagnostic Instrument Systems
- Decided: May 17, 1996 after 78 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
Longest line of descent: 1 generation back to K910834 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910834: QBC Autoreader, Bd Becton Dickinson Vacutainer Systems Preanalytic (1991) Summary page 1.
- K953340: QBC Accutube, Becton Dickinson Diagnostic Instrument Systems (1995) Summary page 1.

## Indications for use
The QBC® AUTOREAD™ System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, MCHC, platelet count, white blood cell count, granulocyte count (% and number), and lymphocyte/monocyte count (% and number).

Source page: https://510kreport.com/device/K960827
Methodology: https://510kreport.com/methodology