Announcement of Fda 510(k) Clearance for Cd4 Monitoring System.

Guava Technologies, Inc., a developer of cost-effective and accessible cell-analysis systems for life science research, drug discovery, development and clinical diagnostics, today announced that Guava has received 510(k) clearance from the U.S. Food and Drug Administration for the Guava® EZCD4 System, which includes the EZCD4 Assay, the PCA Instrument and CytoSoft v2.3 Software, incorporating three modules (EZCD4, Guava Check and Clean and Shutdown). The EZCD4 System is intended to identify and quantify absolute counts of CD4+ T-Lymphocytes in EDTA whole blood. Utilising Guava's easy-to-use and cost-effective Microcapillary Cytometry Technology, the Guava EZCD4 System is intended for the ongoing monitoring of patients with documented diagnosis of an immunodeficiency disease.

Absolute counts of CD4+ T-cells can be useful in characterising, monitoring and evaluating the effectiveness of treatment for autoimmune and immunodeficiency diseases. Determining the number of CD4+ T-cells can be useful in monitoring human immunodeficiency virus (HIV)-infected individuals.

The Guava® EZCD4 Assay is a two-color, direct immunofluorescence reagent kit intended for use with a Guava PCA System. The kit consists of a monoclonal anti-human CD3 antibody that uniquely identifies T-cells and a monoclonal anti-human CD4 antibody that allows the identification of human helper/inducer CD4+ T-cells (HLA Class II reactive).