BioMérieux Gets 510(k) Clearance for Vidas Nephrocheck Assay

BioMérieux has received 510(k) clearance from the FDA for its Vidas Nephrocheck assay for detecting kidney stress in patients at risk of acute kidney injury.

Acute kidney injury is a sudden condition that often occurs as a complication of another serious illness. The assay, which can identify kidney stress prior to actual damage and when an early intervention is still possible, is used in combination with clinical evaluation to assess the risk of moderate or severe acute kidney injury in acutely ill patients, the company said.

The Vidas automated benchtop immunoanalyzer allows for other tests to be run concurrently for diagnosis of sepsis, which can cause acute kidney injury.

BioMérieux plans to launch Vidas Nephrocheck in the U.S. in 2023. The CE marked assay has been available in Europe since 2021.