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# FDA Clears Longer Shelf Life for Astute Medical’s Kidney Test
- URL: https://www.fdaweb.com/fda-clears-longer-shelf-life-for-astute-medicals-kidney-test/
- Published: 2016-06-09T12:00:00.000Z
- Updated: 2026-09-14T21:08:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135894

FDA has cleared an Astute Medical 510(k) for the NephroCheck Test Kit that will extend its shelf life from 16 weeks to 12 months when refrigerated. The test is designed to help determine if certain hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following test administration. “Early knowledge that a patient is likely to develop AKI may prompt closer patient surveillance and help prevent permanent kidney damage or death,” the company says. The extended shelf life will allow labs to maintain larger inventories to support test demand from critical care units, it says.

Astute says that hospital-acquired AKI has been shown to strike in up to 18% of hospital patients and up to 50% of intensive care unit patients. It often occurs as a complication of common events, including infection, surgery or trauma, and requires timely intervention in order to prevent irreversible kidney damage.