AT-HOME TESTS: Man Enters Guilty Plea After Selling Unapproved Kits over Internet
A New Jersey man pled guilty yesterday to federal charges of "distributing misbranded medical devices with the intent to mislead," after he sold 628 HIV home testing kits without FDA approval over the Internet, the AP/Washington Post reports. The kit, called Ana-Sal, is produced by Americare Biologicals Inc., a subsidiary of Americare Health Scan Inc., and claimed to produce results in five minutes with 99% accuracy. But Assistant U.S. Attorney Scott Christie said FDA tests of the device disproved those claims (AP/Washington Post, 10/26). The tests kits include a sponge, with which users collect saliva and then place into a tube. Saliva is then dropped into a "chemical-coated receptacle" with an eyedropper and a color change indicates whether the saliva contains an HIV indicator. The kits sold for $49.95 each and generated $31,368 in sales between October 1997 and March 1999. The company never sought FDA approval, as it sold the tests to other countries where it was approved for use. General Counsel of Americare Health Scan Miyoshi Smith said that the company had notified the FDA of the illegal sales and sent "cease and desist" lettThis is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.