# K072096: CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Aug 20, 2007 after 20 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 K934497 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K983032: CBC-5D Hematology Control, R&D Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K130962: R&D 5D Retic Hematology Control (2013), 0 descendants of its own

## Indications for use
It is an established laboratory procedure to use stable controls to monitor the performance of diagnostic tests. The CBC-5D Plus Retics Hematology Control is designed to document and monitor values obtained from Coulter® hematology instruments. For in vitro Diagnostic Use Only

Source page: https://510kreport.com/device/K072096
Methodology: https://510kreport.com/methodology