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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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November 4, 2009 Approval Letter - Procleix Ultrio Assay

Our STN:   BL 125113/33                                    

Gen-Probe Incorporated
Attention:  Ms. Patricia Bakke
10210 Genetic Center Drive
San Diego, CA  92121

Dear Ms. Bakke:

We have approved your request to supplement your biologics license application for Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and HCV and HBV/Nucleic Acid Pooled Testing/Synthetic) (PROCLEIX® ULTRIO Assay) to include labeling changes to the Package Insert (PI) within the Intended Use and Performance Characteristics section with the revised wording and data to support a supplemental claim for use of the PROCLEIX® ULTRIO Assay to confirm HIV-1 and/or HCV infection in specimens that are repeat reactive in a licensed donor screening test(s) for antibodies to HIV-1 and/or HCV.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h.  Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).

All promotional claims must be consistent with and not contrary to approved labeling.  You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/Signature/

Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research