2021-10-13_FDA Request for Additional Information The FDA October 13, 2021 additional information letter for EUA210582 details deficiencies in FloodLAMP’s QuickColor COVID-19 Test validation, including gaps in intended-use population description, unsupported specimen claims, sub-threshold clinical performance, lack of low-viral-load positives, and required updates to inclusivity/variant analysis, cross-reactivity, and interference testing. It also addresses control material expectations and the regulatory risks of relying on RUO-labeled reagents, outlining acceptable alternatives and warning of possible withdrawal or suspension of distribution if adequate data were not provided by the deadline. primary file regulatory fl-fda-correspondence 2021-10-13_FDA Request for Additional Information.md regulatory/fl-fda-correspondence/2021-10-13_FDA Request for Additional Information.md 2021_10_13 pdf CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 2948 4365 gfile-url xfile-github-download-url pdf-gdrive-url pdf-github-url github-markdown-url github-markdown-download-url web-pdf-url web-slides-url youtube-url web-url