First Check
This article was originally published in The Gray Sheet
Executive Summary
Worldwide Medical announces U.S. launch of the cholesterol home screening product June 5. First Check tests will retail for $14.99 each, and a two-test kit will sell for $24.99. Lake Forest, California company also signs a distribution agreement with Kroger to carry two First Check drugs of abuse (DOA) tests in the chain's food and drug outlets. Worldwide began marketing the First Check OTC line, which also includes tests for alcohol and colorectal disease, in 1997. First Check received clearance via 510(k) last year, but the firm has been at odds with FDA over regulatory authority for the home-use DOA tests. FDA lodged a Feb. 2 complaint seeking over $3 mil. in civil money penalties, claiming that Worldwide Medical marketed the tests without clearance between July 14, 1999 and June 20, 2000 (1"The Gray Sheet" Feb. 12, 2001, p. 16)
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