LXN plans U.S. launch of Duet fructosamine/glucose monitor in early 1998.
This article was originally published in The Gray Sheet
Executive Summary
LXN CORP. U.S. SHIPMENTS OF DUET O-T-C FRUCTOSAMINE/GLUCOSE MONITOR will begin in early 1998 at the earliest, the firm says. LXN received 510(k) clearance June 13 for over-the-counter sale of the monitor for use by diabetics to measure fructosamine. The firm, which obtained FDA clearance in June 1996 for self-measurement of glucose with the same meter, will defer marketing until it is able to offer both tests together. Discussions with FDA are ongoing to determine if an additional 510(k), or supplemental data to the fructosamine 510(k), would be required to market the Duet for measuring glucose and fructosamine at the same time.