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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Rapid Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit and AIDS Test - Untitled Letter

 

April 17, 2012
 
 
UPS EXPRESS MAIL
 
Best Choice BioResearch
10/F, Great Smart Tower
230 Wanchai Road
Wanchai, Hong Kong
 
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.private-hiv-test.com. Your website promotes the HIV Self Test Kit, identified also as Rapid Human Immunodeficiency Virus (HIV 1+2) Antibody Test Kit and AIDS Test, as a test to determine the presence of HIV (Human Immunodeficiency Virus) 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)(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 the HIV test kit in the United States. Instead, your website appears to promote the HIV Self Test Kit to buyers in the United States. For example, your website sells the device in U.S. dollars. Moreover, the order page includes a drop-down box for selecting any state within the United States, inviting orders for shipment of the product within the United States.
 
If you introduce, or deliver for introduction, the 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.
 
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. We are concerned about the accuracy of some of the statements about the HIV Self Test Kit on your Internet website. For example, you state:
 
“The overall accuracy is 99.6%;”
 
“HIV Self Test Kit is the same test approved for and used in hospitals and clinics nationwide to test for HIV;”
 
“HIV Self Test Kit – FAST, Accurate result in 15 minutes!;” and
 
“. . . the HIV Self Test Kit provides private at-home HIV testing with fast and reliable result, . . . ”
 
In addition, your promotional material is misleading in that your home page includes a picture of the FDA-approved Home Access HIV-1 Test System, but in fact your Internet website is selling an unapproved product.
 
The HIV Self 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 HIV Self 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 Anna M. Flynn at
(301) 827-6201. 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