Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Endotoxin activity assay gets Class II designation: Toronto-based Spectral Diagnostics petition requesting its endotoxin activity assay (EAA) be Class II is granted by FDA. A Federal Register notice will be published shortly, announcing the classification order. The generic device type is identified as "an endotoxin assay...that uses serological techniques in whole blood" and is "intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically-ill patients for progression to severe sepsis." Spectral submitted the de novo petition in April, after CDRH Director David Feigal indicated by letter that he believed the device would qualify for it, provided the firm included "careful and cautionary labeling," the petition notes. In October 2001, FDA's Microbiology Devices Panel voted against approving the EAA PMA, citing concerns about the test's sensitivity and how results would affect clinical therapy decisions (1"The Gray Sheet" Oct. 15, 2001, p. 7)...