May 10, 2005
Mr. Jerry Amster
14000 Prague 4
Dear Mr. Amster:
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.hivrapidselftest.com for the Rapid Visual HIV Test Kit. Your website promotes your screening device as a rapid visual test for the qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) Types 1 and 2, and subtype O, in human serum, plasma, and whole 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 (IDE) exemption under section 520(g). Based on a review of our files, FDA has no information that your product is the subject of an IDE exemption. 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 in the United States and has not received an investigational device exemption from premarket approval. Although your website states the Rapid Visual HIV Test Kit is "Government approved," you have not submitted an application for your product for FDA review.
The Internet website above fails to state that the Rapid Visual HIV Test Kit is not for sale in the United States. Instead, the website appears to promote this product to buyers in the United States. Your website includes statements such as "Buy a HIV test kit online, direct from Ibio Ameritech"; "Ibio Ameritech Direct Price: US$14.95"; "We ship worldwide in plain, discreet packaging by First Class Express Mail"; and "Shipping charge is US$5.00 per purchase, regardless of quantity ordered." Moreover, the United States is included in the 'drop-down' box on the payment page, inviting orders for shipment within the United States.
If you introduce, or deliver for introduction, the unapproved Rapid Visual 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 some of the statements on your Internet website. For example, you state:
- that the Rapid Visual HIV Test Kit is "99% Accurate;"
- "Our revolutionary HIV self-test kit gives rapid test results in under 15 minutes;" and
- "Self-test for HIV in the privacy of your home with our Home HIV test kit, the premier home testing kit that gives immediate results."
Such statements, when made in connection with products distributed in the United States, must not be false or misleading in any particular.
The Rapid Visual HIV Test Kit may not be legally marketed in the United States absent premarket approval or an IDE. 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.
If you have any questions regarding this letter, you may contact Ms. Wendy Hively at (301) 827-6201. We remind you that only written communications are considered official.
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Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research