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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 18, 2009 Approval Letter - Ortho HCV Version 3.0 ELISA Test System

Our STN:   BL 103065/5045 

February 18, 2009                   

Ortho-Clinical Diagnostics, Inc.
Attention:  Laura C. Vellucci, Ph.D.
1001 US Highway 202
Raritan, NJ  08869

Dear Dr. Vellucci:

We have approved your request to supplement your biologics license application for Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA), Version 3.0/Recombinant and Synthetic) to revise the package insert to include adding cadaveric specimens under the Intended Use and changes to the Specimen Collection and Preparation section to include new claims for non-interference from total protein (> 9.0 mg/dL), human anti-mouse antibodies (HAMA), and heterophilic antibodies.

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 (three for circulars and 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,

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
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Food and Drug Administration

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Rockville, MD 20852-1448