# K101578: R&D Systems Body Fluid-I Hematology Control

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Apr 28, 2011 after 325 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: 3 generations back to K000076 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053362: Cell-Chex Auto, Streck (2006) Summary page 1.

## Indications for use
The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.

Source page: https://510kreport.com/device/K101578
Methodology: https://510kreport.com/methodology