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    ProNephro AKI™ (NGAL)

    End User Training Program

    This resource is made available to assist with the proper interpretation of test results and to mitigate the risk of incorrect interpretation of these results. The target audience(s) includes Nephrologists, Intensivists, Laboratory Directors and Staff.

  • Introduction

    The Clinical Chemistry Test System, ProNephro AKI ™ (NGAL), is a Class II device in the US and its distribution is governed by the 21 Code of Federal Regulation (CFR) section 862.1220 (Acute kidney injury test system). Risk management activities performed as part of 21 CFR 820.30 design controls, an appropriate end user device training program must be provided while marketing the device. This is part of the efforts to mitigate the risk of incorrect interpretation of test results. 

    This end user device training program includes a knowledge assessment of the trainee to ensure that the training materials have been appropriately reviewed and understood.

  • Knowledge Assessment

    For the knowledge assessment, trainees will be provided with 10 questions. 

    Trainees will be required to score 90% or better (9 out of 10 questions correct) to receive a passing score on the proficiency assessment. If the trainee fails to achieve the required score, they will be able to review the content again and retake the test until a passing score is obtained. 

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