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510(k)

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.

The Access PCT assay can help clinicians assess patients in danger of severe sepsis or septic shock and delivers results in less than 20 minutes. 

The company reported performance changes that led to the product recall and said it is pursuing eventual FDA clearance for the devices.

Luminex got the nod for a qualitative test used to simultaneously detect and identify nucleic acids from respiratory viruses and bacteria.

The firm said its panel, which runs on its MDx-3000 system, tests nasopharyngeal swabs for the most common viruses and bacteria.

The LRT BAL panel detects a wide spectrum of clinically relevant causative agents, such as atypical pathogens and antibiotic resistance markers.

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