# K110718: Cell-Chex with CPPD Crystals

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: May 26, 2011 after 72 days
- Product code: GLQ (Mixture, Control, White-Cell And Red-Cell Indices)
- 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.
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)
- K101335: Cell-Chex, Streck (2010) Summary page 1.

## Indications for use
CelI-ChexTM with CPPD Crystals is an assayed control intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient cerebrospinal fluid and body fluid samples including pleural, pericardlial, peritoneal and synovial fluid. Level 1 contains calcium pyrophosphate dlihydrate (CPPD) Crystals, which can be used to monitor the presence of crystals in synovial fluid. CellCheXTM with CPPID Crystals is also intended for monitoring white blood cell differentiation (Mononuclear, Polymorphonuclear; Neutrophils, Eosinophils, Basophils, Lymphocytes and Monocytes) in body fluid samples performed using Cytospin® smears

Source page: https://510kreport.com/device/K110718
Methodology: https://510kreport.com/methodology