# K051339: R&D CBC-4K Plus Retics Hematology Control

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Jul 12, 2005 after 50 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: 2 generations back to K904464 (1990). 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)
- K970331: CBC-4K Hematology Control, R&D Systems, Inc. (1997) Summary page 1.

## Indications for use
R&D CBC-4K Plus Retics Hematology Control is an assayed whole blood control designed to monitoring the accuracy and precision of CELL-DYN® hematology instruments. Refer to assay sheet for specific instrument models.

Source page: https://510kreport.com/device/K051339
Methodology: https://510kreport.com/methodology