August 12, 2008
Our STN: BL 125113/19
Attn: 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 Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic)(PROCLEIX ULTRIO® Assay) for the following labeling changes:
- Revision of Intended Use to include an HBV screening claim for individual samples and pooled samples of up to 16 individual donations.
- An Intended Use to include testing of pools of up to 16 donations from donors of Hematopoietic Progenitor Cells (HPCs) or Donor Lymphocytes for Infusion (DLI).
- Inclusion of data for HBV yield cases in normal blood donors.
- Adding a long-term storage claim for cadaveric donor specimens.
- Adding instructions for using the PROCLEIX® Reagent Preparation Incubator (RPI)
- Revision of lot release protocol.
- Other minor labeling text revisions.
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.
/Hira L. Nakhasi, Ph.D./
Hira L. Nakhasi, Ph.D.
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research