Regulatory Focus™ > News Articles > Untitled Letter Targets Unapproved HIV Testing Device Posing as Approved Product

Untitled Letter Targets Unapproved HIV Testing Device Posing as Approved Product

Posted 14 February 2013 | By Alexander Gaffney, RAC

A new untitled letter sent by US regulators to an Internet domain hosting company alleges that the company marketed an unapproved diagnostic test capable of testing for HIV, thereby violating federal law.


HIV diagnostic kits were only recently approved for over-the-counter (OTC) sales. In July 2012, the US Food and Drug Administration (FDA) approved OraSure's In-Home OraQuick HIV test after its Blood Products Advisory Committee overwhelmingly supported its approval.

This approval, however, came despite some hesitations regarding the potential for false-positives and false-negatives, both of which were identified as having the potential to impact the lives of patients. FDA's approval notice explained that despite the test's acceptably high rate of accuracy, it still had a false negative rate of 8.3% and a false positive rate of .02%.

Though FDA advisors and regulators were concerned about those rates, they were assuaged in part by the company's pledge to staff a consumer support center available 24 hours a day, seven days a week to educate consumers regarding how to properly use the product and interpret its results.

OraQuick takes between 20 to 40 minutes to complete.

Imposter Product

A website hosted on the domain of Oversee Domain Management LLC, however, touted a "Rapid HIV Blood Test" that is 99.9% accurate and capable of providing results in as soon as 30 seconds-both significantly better than OraQuick, if true.

That's curious, FDA wrote, because the website actually used a picture of OraQuick to represent its own product. "In fact your Internet website is selling in its place, the unapproved, Home Bio Test kit product," it said.

But FDA's untitled letter-likely sent instead of a warning letter because FDA said it was not aware of the product being introduced into interstate commerce-notes the device would be illegal if marketed to anyone, let alone directly to consumers. That's because as devices, the products require approval under either a Premarket Approval (PMA) application or clearance through a 510(k) premarket notification submission, of which the device had neither.

FDA's letter, sent 18 December 2012, adds that the agency is "concerned about the accuracy of some of the statements" it makes about the test. In addition to the accuracy and time claims, the website also claims the test is "clinically confirmed for home testing" and "highly sensitive."

It's not clear from FDA's letter who, exactly, owned the website. Domain name management services, such as, usually only register domain names with other services or provide hosting services. Rarely do they actually conduct commerce using domain names other than their own. Oversee Domain Management notes that it hosts "over 600,000 domain names," making it more likely that a third-party group had set up the website using fake credentials.

The website has since been taken down from the internet and was unavailable to be viewed in cached form.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.