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Vaccines, Blood & Biologics
From: CBER Internet Surveillance
Re: Marketing of Unapproved HIV Test Kit
Date: April 3, 2012
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 the Internet website http://www.genstore.net. The website promotes the SD BIOLINE HIV-1/2 3.0 Test as an immunochromatographic test for the differential and qualitative detection of IgG, IgM, IgA antibodies specific to HIV-1, including subtype O, and HIV-2 simultaneously in human serum, plasma, or whole blood.
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 the referenced 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, the website appears to promote the SD Bioline HIV-1/2 3.0 Test to buyers in the United States. For example, the website sells the device in U.S. dollars. Moreover, the United States is included in the “drop-down” box on the payment page, inviting orders for shipment of the product within the United States.
If you introduce, or deliver for introduction, the SD BIOLINE HIV-1/2 3.0 Test 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 SD BIOLINE HIV-1/2 3.0 Test on the Internet website. For example:
“The whole manufacturing process is regulated by the US Food and Drug Administration (FDA) . . .;” and
“Sensitivity: 100%, Specificity: 99.8%”
The SD BIOLINE HIV-1/2 3.0 Test 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 product 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.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research