Vaccines, Blood & Biologics
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Procleix Ultrio Assay
STN# 125113
Proper Name: 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)
Tradename: Procleix Ultrio Plus Assay
Manufacturer: Gen-Probe, Inc, License #1592
Indication:
- Intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors.
- The assay is intended for use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors.
- It is also intended for use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma.
- This assay is intended to be used in conjunction with licensed tests for detecting antibodies to HIV-1, HCV, and hepatitis B core antigen (anti-HBc), and with licensed tests for hepatitis B surface antigen (HBsAg).
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Supporting Documents
December 23, 2011 Approval Letter - Procleix Ultrio Assay
Labeling changes to the Intended Use and Performance Characteristics of the package insert to use the Ultrio Assay as a test that confirms HBV infection in specimens that have a repeat reactive result in a licensed donor screening test(s) for HBsAg.January 28, 2011 Approval Letter - Procleix Ultrio Assay
To update the package inserts to remove content related to the “10% Invalid Rule” due to revisions of the assay software used to perform these assays on the PROCLEIX TIGRIS System.- November 4, 2009 Approval Letter - Procleix Ultrio Assay
PI revised within the Intended Use and Performance Characteristics section with the revised wording 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. August 12, 2008 Approval Letter - Procleix Ultrio Assay
Multiple revisions in PI.May 23, 2007 Approval Letter - Procleix Ultrio Assay
Revisions included to add the Procleix TIGRIS System for use with the Procleix Ultrio Assay.October 3, 2006 Approval Letter - Procleix Ultrio Assay
Is a qualitative in vitro nucleic acid assay system to screen for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA in plasma and serum specimens from individual human donors.Summary Basis for Regulatory Action - Procleix Ultrio Assay (PDF - 831KB)
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