# K051706: IQ Body Fluids Control

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Aug 17, 2005 after 51 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 K000076 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000076: Cell-Chex, Streck Laboratories, Inc. (2000) Summary page 1.

## Most influential descendants
- K053362: Cell-Chex Auto (2006), 5 descendants of its own
- K120744: XN Check BF (2012), 2 descendants of its own
- K141957: XN Check BF (2014), 1 descendant of its own
- K160588: XN Check BF (2016), 0 descendants of its own
- K101578: R&D Systems Body Fluid-I Hematology Control (2011), 0 descendants of its own

## Indications for use
iQ® Body Fluids Controls are intended for use on iQ® Series analyzers, with the optional iQ® Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The device will consist of two levels of red blood cells and nucleated cells.

Source page: https://510kreport.com/device/K051706
Methodology: https://510kreport.com/methodology