Testkitmart Distributing Unapproved HIV Tests: CBER

CBER says the Web site testkitmart.com is promoting two HIV tests — the iCare HIV 1&2 Rapid Screen Test and the iCare One-Step HIV 1/2 Oral Fluid Test — in the U.S. when the tests are not approved for sale here and have not received IDE exemptions from premarket approval. A 7/27 untitled letter says the Web site promotes sale of the tests in U.S. dollars and includes the U.S. in a drop-down box on the payment page, inviting orders for product shipment to this country.

The agency letter also expresses concerns about the accuracy of labeling for both tests, and questions some of their claims on sensitivity, specificity, and reliability of results.

The Web site registrant was told to take prompt action to correct the violations and not introduce the tests into U.S. commerce until approvals have been received and the devices otherwise comply fully with the Federal Food, Drug, and Cosmetic Act.