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Vaccines, Blood & Biologics


December 18, 2008


6130 Elton Avenue
Las Vegas, NV 89107

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 Your website promotes your HIV Test Kit as a “complete ten-minute test for you to use at home” and also states “Our HIV Test Kit is able to detect HIV 1 and HIV 2 in 10 minutes.” 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 Test Kit in the United States. Instead, your website appears to promote your HIV Test Kit to buyers in the United States. For example, your website sells the device in U.S. dollars, using statements such as “4 HIV Test Kits $139” and "2 HIV Test Kits $99." 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 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.

Product labeling that is false and 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) of the Act. We are concerned about the accuracy of some of the other statements on your Internet website. For example, you state:

  • “Our HIV Test Kit is clinically proven to be greater than 99.9% accurate using the same tests run by doctors and hospitals;” and
  • “The HIV Test Kit has been thoroughly and successfully tested for its reliability and sensitivity.”

Your HIV 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 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 Anna M. Flynn at (301) 827-6201. Please be advised that only written communications are considered official.


-- signature --

Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research


6130 W. Flamingo Road
Las Vegas, NV 89103

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