FDA Product Code PIG: Acute Kidney Injury Test System
An Acute Kidney Injury Test System Is Intended To Measure One Or More Analytes In Human Samples As An Aid In The Assessment Of A Patient's Risk For Developing Acute Kidney Injury. Test Results Are Intended To Be Used In Conjunction With Other Clinical And Diagnostic Findings, Consistent With Professional Standards Of Practice, Including Conifmration By Alternative Methods.
Leading manufacturers include Biom?rieux SA and Bioporto Diagnostic, Inc..
FDA 510(k) Cleared Acute Kidney Injury Test System Devices (Product Code PIG)
About Product Code PIG - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code PIG since 2014, with 4 receiving FDA clearance (average review time: 284 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
PIG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →