Needs and Opportunities (Problem/Challenge):  Need for scientifically sound and practical study design recommendations when evaluating analytical performance characteristics of POC devices using capillary whole blood specimens.

Vision (Solutions):

Develop and define clear analytical validity study designs for Point of Care devices (quantitative and qualitative) that use fingerstick capillary blood specimens.

Value to Stakeholders:

  • Patients:  Expedited access to less invasive and more accessible diagnostic medical device technologies
  • Industry:  Decrease time and cost of analytical testing for POC devices which use fingerstick capillary blood specimens
    • Support CDRH’s mission to maintain US leadership in medical device innovation and expedited patient access to new technologies
    • Improved data quality for regulatory submissions that include capillary samples