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U.S. Department of Health and Human Services

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April 30, 2010 Approval Letter - Abbott Prism Chagas

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

Our STN: BL 125361/0
Abbott Laboratories
Attention: Ms. Susan Sanborn
Diagnostics Division, D-49C/AP6C-2
100 Abbott Park Road
Abbott Park, IL 60064-6092 

Dear Ms. Sanborn: 

We approved your biologics license application for Trypanosoma cruzi (E. coli, Recombinant) Antigen effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce Trypanosoma cruzi (E. coli, Recombinant) Antigen under your existing Department of Health and Human Services U.S. License No. 43. Trypanosoma cruzi (E. coli, Recombinant) Antigen is an in vitro chemiluminescent immunoassay indicated for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi), the causative agent of Chagas disease, in human serum and plasma specimens. The Trypanosoma cruzi (E. coli, Recombinant) Antigen assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components and other living donors, for the presence of antibodies to T. cruzi. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. 

Under this authorization, you are approved to manufacture Trypanosoma cruzi (E. coli, Recombinant) Antigen at the following facilities: 100 Abbott Park Road, Abbott Park, IL 60064, ---------------------------------------------------------(b)(4)----------------------------------------------------------------------------------. You may label your product with the proprietary name ABBOTT PRISM Chagas, and market it as approved in your license application. 

We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion. 

The dating period for Trypanosoma cruzi (E. coli, Recombinant) Antigen shall be 12 months from the date of manufacture when stored at the appropriate temperature required for each kit component. The expiration date for the packaged product, ABBOTT PRISM Chagas, shall be dependent on the shortest expiration date of any component. 

Please submit final container samples of the product ABBOTT PRISM Chagas and each kit component in final containers together with protocols showing results of all applicable tests. 

You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER). 

You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of Trypanosoma cruzi (E. coli, Recombinant) Antigen, or in the manufacturing facilities. 

You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448. 

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. Please provide an electronic, PDF copy and three original paper copies for circulars and other labels. 

In addition, two draft copies of the proposed introductory promotional labeling may be voluntarily submitted for advisory comment with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. 

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 or substantial clinical experience to support such claims [21 CFR 202.1(e)(6)]. 

You must submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by [21 CFR 600.80(k)(2)]. Since your product is characterized as a device as well as a biological, submit these reports to the MedWatch System using MedWatch Reporting Form 3500A. Required reports should be submitted to the Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70. 

We acknowledge your written commitments as described in your letter of April 16, 2010, as outlined below: 

1. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. 

2. ------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. 

We request that you submit information concerning nonclinical postmarketing commitments and final reports to your BLA, STN BL 125361/0, within 12 months following licensure of the ABBOTT PRISM Chagas assay.

Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate: 

  • Postmarketing Study Correspondence 
  • Postmarketing Study Commitment – Final Study Report 
  • Supplement Contains Postmarketing Study Commitment – Final Study Report 

For each postmarketing commitment not subject to the reporting requirements of 21 CFR 601.70, you may report the status to FDA as a “PMC Submission – Status Update.” The status report for each commitment should include: 

  • The original schedule for the commitment, and 
  • The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted). 

When you fulfill your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report. 

Sincerely yours, 

Jay S. Epstein, M.D.
Director
Office of Blood Research and Review
Center for Biologics Evaluation and Research