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 Astute Medical, Inc., Biom?rieux SA and Bioporto Diagnostic, Inc..
5
Total
4
Cleared
284d
Avg days
2014
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Acute Kidney Injury Test System Devices (Product Code PIG)
5 devices
Cleared
Dec 07, 2023
ProNephro AKI™ (NGAL)
Bioporto Diagnostic, Inc.
Chemistry
90d
Cleared
Jul 08, 2022
VIDAS NEPHROCHECK
Biom?rieux SA
Chemistry
479d
Cleared
Nov 16, 2017
NEPHROCHECK Test System
Astute Medical, Inc.
Chemistry
181d
Cleared
Jun 01, 2016
NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
Astute Medical, Inc.
Chemistry
212d
Not Cleared
Sep 05, 2014
NEPHROCHECK TEST SYSTEM
Astute Medical, Inc.
Chemistry
457d
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 1 in the prior period.