June 1, 2021

This document is intended to serve as a study design blueprint for analytical validation of IVDs using capillary whole blood specimens collected by fingerstick, herein referred to as “fingerstick” or “FS” specimens.

This document provides general guidance on considerations for study design. Considerations for specific devices may require modifications to implement these studies.

Reading and following this document does not guarantee either FDA approval/clearance or payment from insurance companies.

The Blueprint is organized into seven key sections:

  • Section One: Introduction introduces the scope of the Blueprint, provides key definitions and explanation of acronyms, and reviews regulatory considerations of point of care testing (POCT) devices.
  • Section Two: Study Designs for Candidate Device Clearance/Approval as a Non-Waived Test reviews design considerations including collection and testing sites and operators, overall study design for FS and FS and venous whole blood (WB) specimens, and detailed considerations for method comparison studies and precision studies.
  • Section Three: Study Designs for CLIA Waiver Application for the Candidate Device reviews design considerations including collection and testing sites and operators, as well as the sequential and dual approaches for CLIA waiver studies for non-waived and new devices, respectively.
  • Section Four: Considerations for the Use of Surrogate Samples outlines design considerations for method comparison studies and precision studies that use surrogate samples.
  • Section Five: Considerations for Data Analysis in Method Comparison Studies discusses over sampling in method comparison studies and considerations for data analysis, including visual presentation of data, regression analysis, and bias at medical decision levels (MDLs).
  • Section Six: Considerations for Data Analysis in Precision Studies reviews components of variability and considerations for visual presentation of precision study data.
  • Section Seven: Additional Considerations for Precision Studies with Fingerstick (FS) Specimens reviews additional precision study design considerations not covered earlier in the Blueprint.