CHATSWORTH, Calif.--(BUSINESS WIRE)--IRIS INTERNATIONAL, INC. (NASDAQ: IRIS), after extensive consultation with the US Food and Drug Administration (FDA), intends to resubmit its 510(k) for its NADiA™ PSA (Prostate Specific Antigen) ultra-sensitive diagnostic test with a prognostic claim. Following FDA advice, IRIS has already submitted a request for a Pre-Investigational Device Exemption meeting (Pre-IDE Meeting), an optional process through which the applicant consults with the FDA for the purpose of improving the quality of submissions and to shorten review times. IRIS will submit a new 510(k) seeking clearance of a prognostic claim for identifying post-prostatectomy patients with low-risk of prostate cancer recurrence, with an estimated timeline for anticipated market introduction in the first half of 2009, it was announced today by César García, Chairman, President and CEO of IRIS International.
