Dual 510(k)/CLIA Waiver Study of a POC Test
Health Decisions successfully addressed a variety of challenges in the successful execution of a dual 510(k)/CLIA waiver study of a point-of-care (POC) diagnostic for influenza. Challenges included starting enrollment late in the flu season because of a delay in manufacturing of the investigational test. Study execution required implementing a complex study design to address requirements for both 510(k) and CLIA waiver. In addition, the project team had to ensure sample integrity when the investigational test and the comparator required midturbinate and nasopharyngeal swabs respectively.