# K042094: R&D CBC-XE Hematology Control

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Sep 1, 2004 after 29 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 K913879 (1991). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913879: CBC-8K (TM) Hematology Control/Multiple, R&D Systems, Inc. (1991) Summary page 1.

## Most influential descendants
- K160606: BC-5D Hematology Control (2016), 0 descendants of its own
- K100050: R & D Systems Xeret Hematology Control (2010), 0 descendants of its own

## Indications for use
R&D CBC-XE Hematology Control is a tri-level control designed for use in monitoring the accuracy and precision of Sysmex TM hematology instruments. Refer to assay sheet for specific instrument models.

Source page: https://510kreport.com/device/K042094
Methodology: https://510kreport.com/methodology