Roche AmpliChip CYP450 microarray
This article was originally published in The Gray Sheet
Executive Summary
Marketing plans for the Roche instrument, currently regulated as an analyte-specific reagent, have not changed at this time, though the company continues to hold discussions with FDA in the wake of a 1July letter from Office of In Vitro Diagnostic Devices Director Steve Gutman. OIVD cited public statements from Roche suggesting that the microarray is "an assembled device that is part of a specific test system," which, according to Gutman, would imply that AmpliChip is inaccurately classified, and may be subject to stricter regulation (2"The Gray Sheet" July 14, 2003, p. 20). Roche Molecular Diagnostics, based in Pleasanton, Calif., met with FDA the week of July 21 and has had several teleconferences with the agency over the microarray, developed under an agreement with Affymetrix...