NephroCheck test regulatory update

FDA granted 510(k) clearance to Astute's NephroCheck Test System to assess the risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. The product is for use in ICU patients ages >=21 years who currently have or have had within the past 24 hours acute cardiovascular and/or respiratory compromise. The test was reviewed through FDA's de novo pathway, which is an alternative path to market for devices that are lower risk and may not require a PMA but are of a new type and would not be cleared via the 510(k) pathway. Astute said partner Ortho-Clinical Diagnostics Inc. (Raritan, N.Y.) will launch the test in the U.S. in the "coming weeks." The test is already marketed in the EU. ...