FDA Clears Lab Test for Predicting Acute Kidney Injury (AKI)
NephroCheck detects substances in the urine that are associated with AKI.
The FDA has cleared for marketing the NephroCheck test, a first-of-a-kind laboratory test to identify critically ill hospitalized patients at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following administration of the test.
“Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in an FDA press release. “The NephroCheck provides health care providers with a quick, validated method of assessing a patient's AKI risk status which may inform patient management decisions.”