Vaccines, Blood & Biologics
December 18, 2008
RETURN RECEIPT REQUESTED
1925 SW FWY
Houston, Texas 77098
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 website http://www.idiagnosticsco.com. Your website promotes your Rapid HIV Test – Blood and Rapid HIV Test – Urine as rapid test devices for detecting antibodies to Human Immunodeficiency Virus (HIV). Copies of the pertinent Internet website pages are enclosed for your reference.
Rapid 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 devices promoted on your Internet website are not approved for sale in the United States and have not received investigational device exemptions from premarket approval.
The Internet website above does not exclude the sale of your rapid HIV test devices in the United States. Instead, your website appears to promote your HIV rapid test devices to buyers in the United States. For example, your website sells those devices in U.S. dollars, using statements such as “Rapid HIV Test – Urine, Product Price $11.49” and "Rapid HIV Test – Blood, Product Price $11.99." Moreover, the United States is included in the “drop-down” box on the payment pages, inviting orders for shipment of your products within the United States.
If you introduce, or deliver for introduction, your unapproved Rapid HIV Test – Blood and/or Rapid HIV Test – Urine 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 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 website. For example, you state:
- “Our tests are manufactured to the highest quality standards;”
- “The overall accuracy of an iDiagnostics HIV test, when administered correctly, is 99%;” and
- “ . . . our HIV and STD tests are backed by multiple clinical studies.”
Your Rapid HIV Test – Blood and Rapid HIV Test – Urine may not be legally marketed in the United States absent premarket approval or IDEs. You should take prompt action to correct the violations referenced above. To avoid violating the Act, you must refrain from introducing your products into U.S. interstate commerce, and refrain from delivering your products for introduction into U.S. interstate commerce, until you have obtained premarket approval or IDEs for your devices, and your devices otherwise comply 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
Enclosure: Internet website pages from http://www.idiagnosticsco.com
2039 Grand Terrace
Sugar Land, Texas 77479