Roche Amplicor chlamydia test sensitivity claims questioned in FDA warning letter.
This article was originally published in The Gray Sheet
Executive Summary
ROCHE AMPLICOR CHLAMYDIA PCR TEST PACKAGE INSERT PERFORMANCE CLAIMS are being discussed by the firm and FDA, Roche says. The agency sent Roche Molecular Systems a warning letter on May 11 alleging that specific performance claims contained in the insert do not represent the actual performance of the device.