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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.1mintest.com. Your website promotes the EZ-TRUST Rapid HIV Home Test kit, identified also as the 1MinTest, as a test to determine the presence of Human Immunodeficiency Virus 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) in part because they are in vitro diagnostic instruments intended for use in the diagnosis of disease or other conditions. 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 provide a reasonable assurance of safety and effectiveness.
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 includes the sale of the EZ-TRUST Rapid HIV Home 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, EZ-TRUST Rapid HIV Home Test kit, identified also as the 1MinTest, into interstate commerce in the United States, you would be distributing an adulterated device in violation of sections 301(a) and 501(f)(l)(B) of the 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) of the Act.
Furthermore, we are concerned about the accuracy of some of the statements about the EZ-TRUST Rapid HIV Home Test kit on your Internet website. For example:
- “EZ-TRUST Rapid HIV Home Test Kit will give the user a private, sensible, quick and accurate rapid test results in 5 minutes to ascertain if the user is infected with HIV virus. It is an aid only to identify infected individuals;”
- “It detects for HIV Antibodies;”
- “Highly accurate (99.9% vs EIA method). (as obtained from clinical evaluation trials results);”
- “Highly sensitive (99.9%);”
- “Highly specific (99.9%).”
The EZ-TRUST Rapid HIV Home 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 further violations of the Act, you must refrain from introducing the EZ-TRUST Rapid HIV Home 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) 827-6201. 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