December 13, 2006 Approval Letter
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-1448
December 13, 2006
Our STN: BL 125161/0
Ortho-Clinical Diagnostics, Inc.
Attention: Andrea Casper
1001 US Highway 202
Raritan, NJ 08869-0606
Dear Ms. Casper:
We have approved your biologics license application for Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen under your existing Department of Health and Human Services U.S. License No. 1236. Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen is indicated for use as a donor screening test to detect antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors of whole blood, blood components or source plasma, and other living donors. It is also intended for use to screen organ and tissue donors when specimens are obtained while the donor's heart is still beating. This test is not intended for use on specimens from cadaveric (non-heart-beating) donors. This test is not intended for use on samples of cord blood.
The ORTHO T. cruzi ELISA Test System is intended for use in a fully manual mode, in semi-automated mode using the Ortho Summit Sample Handling System (Summit) or in automated mode with the Ortho Summit System (OSS).
Under this authorization, you are approved to manufacture Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen at your facility in Raritan, New Jersey. You may label your product with the proprietary name ORTHO T. cruzi ELISA Test System and will market it in 480 Test Kit and 2400 Test Kit sizes.
The dating period for Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen shall be 12 months from the date of manufacture when stored at 2-8 oC.
Please submit final container samples of the product 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 the manufacturing, testing, packaging or labeling of Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen, or in the manufacturing facilities.
We acknowledge your written commitments as described in your letter of November 20, 2006 as outlined below:
- Ortho-Clinical Diagnostics commits to performing a post market study to collect and report data on the clinical performance of the fully manual operation of the assay. Manual operation shall be defined as; manually pipetted plates processed using an incubator, AutoWash 96, and AutoReader IV. Not less than 2,121 random donor samples at a donor site shall be tested and the study will be completed and reported to FDA within one year of licensure.
Submit adverse experience reports in accordance with the Medical Device Reporting requirements for medical devices (21 CFR 803) as required by (21 CFR 600.81(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, PO Box 3002, Rockville, Maryland 20847-3002.
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 a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling 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. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by FDA Form 2253.
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 submitted data to support such claims to us and had them approved.
--- signature ---
J ay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research