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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Oversee Domain Management, LLC - Untitled Letter

December 18, 2012 


UPS EXPRESS MAIL
 
Oversee Domain Management, LLC
515 S. Flower Street
Suite 4400
Los Angeles, California 90071
 
To Whom It May Concern:
 
The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research of the United States Food and Drug Administration (FDA) has reviewed your Internet website http://www.homebiotest.com Your website promotes the Home Bio Test kit, identified also as Rapid HIV Blood Test, as a test to determine the presence of Human Immunodeficiency Virus (HIV 112) antibodies in human blood.  Copies of the pertinent Internet website pages are enclosed for your reference.
 
HIV test kits are medical devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are in vitro diagnostic instruments intended for use in the diagnosis of disease.  Under section 513(f) of the Act, the devices are class III devices, which under section 501(f)(l)(B) are deemed to be adulterated unless they have received premarket approval under section 515 or an investigational device exemption (IDE) under section 520(g).  These statutory provisions protect the public health and ensure that new medical devices are safe and effective.
 
The device promoted on your Internet website is not approved for sale in the United
States and has not received an investigational device exemption from premarket approval. The Internet website above does not exclude the sale of the HIV test kit in the United States.  Instead, your website appears to promote the Home Bio Test kit to buyers in the United States.  For example, your website sells the device in U.S. dollars.
 
If you introduce, or deliver for introduction, Home Bio Test kit, identified also as Rapid HIV Blood Test into interstate commerce in the United States, you would be distributing an adulterated device in violation of section 301(a) and 501(f)( l)(B) ofthe Act.
 
Additionally, product labeling that is false or misleading in any particular renders a device misbranded under section 502(a) of the Act.  If you introduce, or deliver for introduction, a misbranded device into interstate commerce in the United States, you would be doing so in violation of sections 301(a) and 502(a) ofthe Act.

 
We are concerned about the accuracy of some of the statements about the Home Bio Test kit on your website.  For example, you state that the Home Bio Test kit is:
 
  • "99.9% accurate;"
  • "Clinically confirmed for Home Testing;"
  • "Highly Sensitive;"
  • "Fastest result within 30 Seconds to 5 minutes."
 
In addition, your promotional material is misleading in that your home page includes a picture ofthe  FDA-approved Orasure HIV-1 Test System, but in fact your Internet website is selling in its place, the unapproved, Home Bio Test kit product.
 
The Home Bio Test kit may not be legally marketed in the United States absent premarket approval or an IDE.  You should take prompt action to correct the violations referenced above.  To avoid violating the Act, you must refrain from introducing the Home Bio Test kit into U.S. interstate commerce, and refrain from delivering the product for introduction into U.S. interstate commerce, until premarket approval or an IDE for the device has been obtained, and your device otherwise complies fully with the Act.
 
If you have any questions regarding this matter, you may contact Najma Khan at (301) 827-6203.  Please be advised that only written communications are considered official.
 
 
Sincerely,
 
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research