August 26, 2009
Administrative and Technical Contact
Sallamander Concepts CC (South Africa)
103 Harvest Crescent
Lynnwood Pretoria, Gauteng 0080
Dear Mr. Meyer:
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 website http://www.sallamanderconcepts.com and its hyperlink www.anytestkits.com/hiv-aids-test-kit.htm. Your website promotes the Sanitoets HIV Test Kit as a rapid test kit for detecting antibodies to Human Immunodeficiency Virus (HIV). 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 (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 exemptions (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 and its hyperlink above do not exclude the sale of the Sanitoets HIV Test Kit in the United States. Instead, your website appears to promote the Sanitoets HIV Test Kit to buyers in the United States. For example, your website and its hyperlink sell the device in U.S. dollars, using statements such as “US $10.00 per kit,” “US price includes delivery – NO extra charges,” “Our price is quoted in US Dollars, as it includes delivery via London (UK) to any part of the world – the USA included” and “The price in US dollar, as listed on each product page, includes postage and packaging to all destinations in the world – so it doesn’t matter if you are ordering from Los Angeles, Lagos, Lima or Liverpool – the US dollar price covers postage and packaging as well.”
Indeed, we have recently been able to confirm that you do in fact ship Sanitoes HIV Test Kits in the U.S.
By introducing, or delivering for introduction, your unapproved HIV test kit into interstate commerce in the United States, you would be distributing adulterated devices in violation of sections 301(a) and 501(f)(1)(B) of the Act.
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, your misbranded device into interstate commerce in the United States, you are violating sections 301(a) and 502(a) of the Act. We are concerned about the accuracy of some of the statements on your Internet website. For example, you state:
- “Our economical HIV test kit is used with great success as a primary screening test to ascertain your HIV status at home;”
- “When properly used and testing procedure is followed the results are accurate…;” and
- “HIV Rapid test is intended as an initial qualitative screening test to detect HIV-1 and 2 antibodies in whole blood within 5 minutes.”
Your HIV 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 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.anytestkits.com/hiv-aids-test-kit.htm