Vaccines, Blood & Biologics
March 9, 2007
Tang shuwei dongti
102 xiatangxincun 54#
lujing xilu yuexiuqu
To Whom It May Concern:
The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research of the Food and Drug Administration (FDA) has reviewed your Internet website http://www.hiv-glucose-testyourself.com. Your website promotes your HIV Self Test Kit as a rapid test device to determine the presence of Human Immunodeficiency Virus (HIV) 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 (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)(1)(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 your HIV rapid test device in the United States. Instead, your website appears to promote your HIV rapid test device to buyers in the United States. For example, your website sells those devices in U.S. dollars, using statements such as "HIV/AIDS Self Test Kit $20" and "HIV Test Kit Only $20.00!!" Moreover, the United States is included in the "drop-down" box on the payment pages, inviting orders for shipment of your product within the United States.
If you introduce, or deliver for introduction, your unapproved HIV Self Test Kit into interstate commerce in the United States, you would be distributing an adulterated device in violation of sections 301(a) and 501(f)(1)(B) of the Act.
Furthermore, your website falsely claims that the HIV Self Test Kit is "FDA Approved." This statement causes your product to be misbranded under section 502(a) of the Act, in that its labeling is false or misleading.
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) of the Act. We are also concerned about the accuracy of some of the other statements on your Internet website. For example, you state:
- "HIV Self Test Kit is the same test approved for and used in hospitals and clinics nationwide to test for HIV;"
- "FAST, Accurate result in 15 minutes;" and
- "The overall accuracy is 99%."
Your HIV rapid test device may not be legally marketed in the United States absent pre-market 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 your product into U.S. interstate commerce, and refrain from delivering your product for introduction into U.S. interstate commerce, until you have obtained premarket approval or an IDE for your device, and your device otherwise complies fully with the Act.
If you have any questions regarding this matter, you may contact Ms. Anna M. Flynn at (301) 827-6201. Please be advised that only written communications are considered official.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Internet website pages from http://www.hiv-glucose-testyourself.com