Vaccines, Blood & Biologics
Easy Kit Info and Http Eu Hiv Test - Untitled Letter
Re-issue March 25, 2010.
To Whom It May Concern:
The Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research of the Food and Drug Administration (FDA) has reviewed your Internet websites http://www.easykit.info and http://eu.hivtest.biz. Your websites promote your HIV 1-2 Rapid Test Kit, identified also as HIV Self Test Kit; Easy Kit – Home HIV Rapid Test Kit; HIV TEST YOURSELF test kit; Easy Kit – Get Negative Result Now! – Home Hiv Test Kit; Home HIV Test Kit; and Rapid Human Immunodeficiency Virus (HIV1+2) Antibody Test Kit, as a rapid test kit for detecting antibodies to Human Immunodeficiency Virus (HIV). Copies of the pertinent Internet websites 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 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 websites is not approved for sale in the United States and has not received an investigational device exemption from premarket approval.
The Internet websites above do not exclude the sale of the HIV test kit in the United States and its territories. Instead, your websites appear to promote the HIV test kit to buyers in the United States and its territories. For example, your website http://www.easykit.info sells the device in U.S. dollars, using statements such as “HIV 1-2 Rapid Test Kit, Product Price $15.00” and "Free shipping to United States." The order page automatically populates the “country” entry with United States, inviting orders for shipment of your product within the United States. Moreover, the Virgin Islands (US) and Puerto Rico (US) are included in the “dropdown” box on the payment page of your website http://eu.hivtest.biz, inviting orders for shipment of your product within the United States territories.
If you introduce, or deliver for introduction, an 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.
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 the accuracy of some of the statements on your Internet websites.
www.easykit.info and http://eu.hivtest.biz
- “The HIV Self Test Kit is the same test approved for and used in hospitals and clinics nationwide to test for HIV;”
- “…the HIV Self Test Kit provides private at-home HIV testing with fast and reliable result…;”
- “The overall accuracy is 99%;”
- “Specificity >99%”; and
- “Easy Accurate Private & Low Cost!”
- “HIV Self Test Kit – FAST, Accurate result in 15 minutes!;” and
- “Instant and easy to understand result.”
- “Home HIV Kit – FAST, Get Accurate Result in 15 Minutes!’
In addition, your promotional material is misleading in that the home page on both of your websites includes a picture of the FDA-approved, Home Access HIV-1 Test System but in fact is selling another unapproved product.
Your HIV test kit may not be legally marketed in the United States and its territories absent pre-market approval or 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 comply fully with the Act.
If you have any questions regarding this matter, you may contact Mary D. Davis-Lopez 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
Internet website pages from http://www.easykit.info and http://eu.hivtest.biz