The specimen discard technology automatically and passively "sidelines" potential contaminants during the blood culture collection process, Kurin said.
The revisions include information on demonstrating accuracy and how to design a single set of comparison and reproducibility studies for dual 510(k) and CLIA waiver submission.
DiaSorin got the nod for the Liaison Lyme Total Antibody Plus assay which uses chemiluminescence to detect lgG and IgM antibodies to Borrelia burgdorferi.
The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.
The Swedish firm Biovica said this and additional studies will form the basis of a US Food and Drug Administration submission for its test measuring thymidine kinase-1.
