# K101335: Cell-Chex

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Aug 23, 2010 after 103 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: 1 generation back to K000076 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K110718: Cell-Chex with CPPD Crystals (2011), 0 descendants of its own

## Indications for use
Cell-Chex 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, pericardial, peritoneal and synovial fluid. Level 1 contains monosodium urate crystals which can be used to monitor the presence of crystals in synovial fluid. Cell-Chex 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/K101335
Methodology: https://510kreport.com/methodology