IRIS International, Inc.

IRIS International Submits 510(k) Application to FDA for iChem(R)VELOCITY(TM) Automated Urine Chemistry Analyzer and iRICELL(R) Urinalysis Workstation

| Source: IRIS International, Inc.

CHATSWORTH, Calif., July 1, 2010 (GLOBE NEWSWIRE) -- 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.

About IRIS International, Inc.

IRIS International is a leading global in vitro diagnostics company focused on products that analyze particles and living cell forms and structures, or morphology of a variety of body fluids. The Company's products leverage its strengths in flow imaging technology, particle recognition and automation to bring efficiency to hospital and commercial laboratories. The initial applications for its technology have been in the urinalysis market and the Company is the leading worldwide provider of automated urine microscopy and chemistry systems, with an installed base of more than 2,700 systems in more than 50 countries. The Company is expanding its core imaging and morphology expertise into related markets and is developing applications in hematology and urinary tract infections. In addition, the Company is developing molecular diagnostic tests based on its Nucleic Acid Detection Immunoassay, or NADiA®, platform, with applications in oncology and infectious disease. For more information, please visit


This press release contains forward-looking statements made in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include statements about the performance of iChem®VELOCITY™, potential FDA clearance of iChemVELOCITY; and statements about the extensive clinical studies, testing and validation of the instrument improvements to address the issues raised by the FDA in the Company's previous submission and in the FDA's recent Pre-IDE review, and are generally identified by phrases such as "thinks," "anticipates," "believes," "estimates," "expects," "intends," "plans," and similar words. Forward-looking statements are not guarantees of future performance and are inherently subject to uncertainties and other factors which could cause actual results to differ materially from the forward-looking statement. These statements are based upon, among other things, assumptions made by, and information currently available to, management, including management's own knowledge and assessment of the Company's internal R&D initiatives and the clinical studies and 510(k) application processes. Other factors and uncertainties that could affect the Company's forward-looking statements include, among other things, unanticipated responses from the FDA with respect to the Company's 510(k) application, and other delays in obtaining FDA clearance of iChemVELOCITY. These and other risks are more fully described in the Company's filings with the Securities and Exchange Commission, including the Company's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which should be read in conjunction herewith for a further discussion of important factors that could cause actual results to differ materially from those in the forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.   

IRIS International, Inc.
Cesar Garcia, Chairman and Chief Executive Officer
818-709-1244, ext. 7123

The Wall Street Group, Inc.
Ron Stabiner