# K072268: HC WBC Hematology Control, Model: WBC00S

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Nov 20, 2007 after 97 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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 K904464 (1990). 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)
- K904464: CBC-Laser (R) Hematology Control/Multiple-Modified, R&D Systems, Inc. (1990) Summary page 1.

## Indications for use
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The HC WBC Hematology Control is designed to monitor values obtained from analyzers that measure white blood cell counts in whole blood.

Source page: https://510kreport.com/device/K072268
Methodology: https://510kreport.com/methodology