IRIS submits 510(k) application for clearance of iChemVELOCITY and iRICELL Urinalysis Workstation

IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostics systems and consumables for use in hospitals and commercial laboratories worldwide, announced today that its IRIS Diagnostics Division submitted on June 30, 2010, a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory clearance for its iChem^®Velocity™ Automated Urine Chemistry Analyzer and iRICELL^® Urinalysis Workstation. 

"Following the collection of additional data and expanded clinical studies and a Pre-IDE review by the FDA, we are pleased to submit our 510(k) application for clearance of the iChemVELOCITY and iRICELL urinalysis workstation," stated César García, Chairman, President and CEO of IRIS International.  "Based upon our extensive clinical studies, testing and validation of the instrument improvements, we feel confident this new 510(k) submission addresses the issues raised by the FDA in our previous submission and in its recent Pre-IDE review," he added.

"While pursuing U.S. regulatory clearance, IRIS launched the iChemVELOCITY to the international market in September 2008, and since that time has sold over 250 instruments with high customer satisfaction, following implementation of certain product enhancements, design improvements and retrofits based on initial customer feedback," Mr. Garcia said.

The iChemVELOCITY system is designed to deliver improved productivity and clinical utility in the medium to high volume hospital and clinical reference labs. 

"The iChemVELOCITY represents a critical element of IRIS's strategy to provide both stand-alone automated urine chemistry analyzers and our fully integrated urinalysis workstation, iRICELL, globally. Upon FDA clearance, the iChemVELOCITY will allow IRIS and its global distribution partners to best meet our customer's needs in the automated urinalysis segment," stated Tom Warekois, President of the IRIS Diagnostics Division. "The global availability of iChemVELOCITY uniquely positions IRIS to supply a proprietary bench top automated urinalysis system from a single-source provider,"  Mr. Warekois said.

The iChemVELOCITY combined with the Company's series of iQ^®200 automated urine microscopy analyzers, forms the portfolio of iRICELL Complete Urinalysis Workstations.