FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA OKs Marketing of NephroCheck AKI Test

Sept. 8, 2014

The FDA on Friday cleared Astute Medical’s NephroCheck AKI test for use in determining if certain critically ill hospitalized patients are at imminent risk of developing acute kidney injury.

The first-of-a-kind laboratory test, cleared via the de novo premarket review pathway, allows for closer patient monitoring, helping to prevent permanent kidney damage or death, the agency says.

Often without symptoms, AKI is a sudden decline in kidney function following an injury to the kidney. The condition can cause fluid buildup, chest pain, muscle weakness, permanent kidney damage or chronic kidney disease. Most at risk are critically ill patients, especially the elderly and those with diabetes or high blood pressure, the FDA notes.

Current tests can only say whether a patient already has AKI. NephroCheck detects the presence of insulin-like growth-factor binding protein 7 and tissue inhibitor of metalloproteinases in the urine — both associated with AKI—and, within 20 minutes, provides a score based on the amount of proteins present, the FDA says. The score coincides with the patient’s risk of developing AKI over the next 12 hours.

The FDA based its decision on two clinical studies of more than 500 subjects at 23 hospitals. NephroCheck accurately detected 92 percent of AKI patients in one study and 76 percent in the other, according to the agency. The test provided a false positive result in about half of the patients without AKI. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.