510(k)

The test completes a suite of assays designed to detect pathogens that can cause sepsis using the firm's ePlex system.

The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.

The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.

The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.

The agency anticipates that the new pathway will promote comparisons with modern products rather than relying on older predicates.

The firm has completed submissions for all three of its ePlex panels for diagnosis and management of bloodstream infections that can lead to sepsis.

The BioCode GPP tests for 17 of the most common bacteria, viruses, and parasites that cause infectious diarrhea, and runs on the BioCode MDx-3000 system.

The test detects and distinguishes pertussis and parapertussis in nasopharyngeal swab samples. It is for use on the Quidel's Solana MDx instrument.

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.