HIV Test Kit Websites Receive FDA Untitled Letters
Posted 07 August 2018 | By
The US Food and Drug Administration’s (FDA) Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research on 27 July sent two untitled letters to the registrants of websites selling unapproved HIV tests.
What should be considered Class III devices are being promoted at www.testkitmart.com
, and are not approved for sale in the US and have not received investigational device exemptions from premarket approval, FDA said.
The Singapore-based registrant’s website (testkitmart.com) appears to promote the iCare HIV 1&2 Rapid Screen Test and the iCare One-Step HIV 1/2 Oral Fluid Test to buyers in the US, FDA said, noting that for example, the website sells the devices in US dollars, and the US is included in the “drop-down” box on the payment page.
“The introduction, or delivery for introduction, of the iCare HIV 1&2 Rapid Screen Test and the iCare One-Step HIV 1/2 Oral Fluid Test into interstate commerce in the United States would be violative under sections 301(a) and 501(f)(1)(B) of the” Federal Food, Drug, and Cosmetic Act
, the untitled letter says.
“Further, the iCare HIV 1&2 Rapid Screen Test product labeling includes the statement ‘For Field and Health Care Professional Use;’ however, statements on your web site include ‘iCare HIV 1&2 Rapid Screen Test is a home HIV test kit that allows you to check your HIV status from the secrecy and convenience of your home,’” the letter notes.
FDA also expressed concerns about the accuracy of the iCare One-Step HIV 1/2 Oral Fluid Test product labeling, which say, “More than 99.61% sensitivity and 100% specificity” and “Reliable Results in less than 20 minutes.”
The New Zealand-based registrant’s website promotes the unapproved iCare HIV 1&2 Rapid Screen Test. All the other details were similar to the Singapore-based website, though FDA said it was concerned about the product labeling that said “>99% Sensitivity and >99% Specificity” and “Reliable and Fast Results in <15 minutes.”
These are the fourth and fifth untitled letters sent this year by CBER.