Prognostic Claim with Resubmission of PSA Test Application
IRIS International, Inc., of Chatsworth, Calif., after extensive consultation with the FDA, plans to resubmit its 510(k) application for the company's NADiA PSA ultrasensitive diagnostic test with a prognostic claim for identifying post-prostatectomy patients at low risk of prostate cancer recurrence.
Following the FDA's guidance, IRIS has already submitted a request for a Pre-Investigational Device Exemption meeting, an optional process through which the applicant consults with the FDA to improve the quality of submissions and shorten review times.
“The new 510(k) submission will seek clearance for the NADiA PSA as an in vitro diagnostic assay intended to be used in conjunction with clinical evaluation as an aid in predicting risk for recurrence of prostate cancer after radical prostatectomy,” said César García, chairman, president, and CEO of IRIS. The company anticipates market introduction of NADiA in the first half of 2009.