Vaccines, Blood & Biologics
InVitro Diagnostics Untitled Letter
June 29, 2009
Tanjong Pagar Plaza
#02-104 Block 7
Singapore, SG 082001
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.ivdkit.com. Your website promotes your HIV test kit as a “ten minute test” and states that your HIV test kit “will give a private, quick, and accurate result, that will show if the user has HIV antibodies.” 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). 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. These statutory provisions protect the public health and ensure that new medical devices are safe and effective.
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. 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.
We are also concerned about the accuracy of some of the statements on your Internet website. In addition to the statement, “Your test kit will give a private, quick and accurate result in 10 minutes,” you further describe your HIV test kit as “accurate, sensitive, and highly specific.” 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.
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
Internet website pages from http://www.ivdkit.com
cc: IPR Management
P.O. Box 248
Singapore, SG 082001