May 23, 2007
Our STN: BL 125113/2
Attn: Leanne M. Kiviharju
10210 Genetic Center Drive
San Diego, CA 92121
Dear Ms. Kiviharju:
We have approved your request to supplement your biologics license application for your Procleix Ultrio Assay to add the Procleix TIGRIS System for use with the Procleix Ultrio Assay.
Your August 23, 2006 written commitment to perform a postmarketing study to demonstrate detection of window period donations for HBV infection remains in effect and eventual licensure of The Procleix Ultrio Assay on the Procleix TIGRIS system for screening for HBV will depend on the TIGRIS being able to detect HBV window period donations in the end user setting.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate.
We will include information contained in the above-referenced supplement in your biologics license application file.
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Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research