IRIS INTERNATIONAL, INC. (NASDAQ GM: IRIS) today announced that it has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance to market its iChem®VELOCITY™ Automated Urine Chemistry Analyzer utilizing the Company’s proprietary Kinetic Imaging technology.
“We are very pleased to file an FDA application for marketing clearance of our iChemVELOCITY, marking a major milestone for the Company and the culmination of a major R&D effort. The iChemVELOCITY embodies a major technological advance in urine chemistry, a sector of the laboratory which has not seen significant innovation in many years,” said César García, IRIS Chairman, President and Chief Executive Officer. “This device will leverage our core image analysis technology to provide a complete and unique benchtop urinalysis solution which, when combined with the iQ®200 Automated Urine Microscopy Analyzer, forms the iRICELL™ Complete Urinalysis™ Workcell.”
Mr. García went on to note that the iChemVELOCITY opens up an incremental $350 million market opportunity in urine chemistry and uniquely positions IRIS as the only company to offer a complete range of fully and semi-automated urinalysis solutions combining both urine chemistry and urine microscopy.
“While pursuing FDA approval, we are proceeding with the international launch of the iChemVELOCITY scheduled for March of 2008,” Mr. García said. “This will allow us to market an integrated system with our iQ200 Automated Urine Microscopy Analyzer in the international marketplace for the first time,” he added.
The iChemVELOCITY system is designed for ease of use and high throughput workload requirements. It is the first urinalysis system to employ IRIS’ proprietary Kinetic Imaging technology, a state-of-the-art imaging system that will optimize the sensitivity and dynamic range of the Company’s urine chemistry strips. The iChemVELOCITY is designed for medium to high volume laboratories that typically process more than 100 urine samples per day.
THE COMPANY
IRIS International, Inc. (www.proiris.com), based in Chatsworth, Calif., is a leading developer, manufacturer, and marketer of medical devices, diagnostic systems and consumables. The Iris Diagnostics Division (www.irisdiagnostics.com) is a leader in automated urinalysis technology with systems in major medical institutions throughout the world. Iris Molecular Diagnostics develops innovative ultra-sensitive diagnostics and sample processing products with applications in the urinalysis, oncology and infectious disease markets. The Company's Sample Processing business unit (formerly the StatSpin® subsidiary) (www.statspin.com), based in Westwood, Mass., manufactures innovative centrifuges and blood analysis products.