# K053362: Cell-Chex Auto

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Jan 13, 2006 after 42 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 K000076 (2000). 2 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K051706: IQ Body Fluids Control, Streck (2005) Summary page 1.

## Most influential descendants
- 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
- K090201: UA-Cellular for IQ (2009), 0 descendants of its own

## Indications for use
Cell-Chex Auto is an assayed whole blood control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples.

Source page: https://510kreport.com/device/K053362
Methodology: https://510kreport.com/methodology