In Furtherance of Productive Discussions with FDA, IRIS to Proceed with New FDA 510k Pre-Market Notification for NADiA PSA

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(TM) 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,...

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