FDA Microbiology Devices Panel Votes Down Sepsis' Endotoxin Activity Assay
This article was originally published in The Gray Sheet
Executive Summary
Sepsis, Inc.' s endotoxin activity assay (EAA) suffered in FDA panel review partly because of the changing nature of bacterial infection in intensive care units.
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Regulatory News In Brief
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)...
Regulatory News In Brief
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)...
Endotoxin Activity Test Manufacturer Claims Superiority Over Cultures Alone
Spectral Diagnostics' assay for ruling out gram-negative infection to aid antibiotic prescribing practices will go before CDRH's Microbiology Devices Panel in Gaithersburg, Maryland Oct. 11.