Endotoxin assays to Class II
This article was originally published in The Gray Sheet
Executive Summary
Endotoxin activity assay manufacturers should include a risk analysis study in premarket notifications to guard against falsely low or high toxin readings, FDA says in a final rule downclassifying the assays from Class III to Class II with special controls. The agency cites "failure of endotoxin tests to perform as indicated or error in interpretation of results" as the primary threat to proper patient management (1"The Gray Sheet" Aug. 11, 2003, p. 19). The rule, published in the Oct. 31 Federal Register, takes effect Dec. 1...
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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)...
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