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.
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