Response to FDA re QuickColor - EUA210582 10-13 The Response to FDA re QuickColor (EUA210582) addresses FDA’s October 13 feedback by proposing updates to the intended use (removing “suspected of COVID” and focusing on serial screening), limiting sample type to nasal swabs only, and defending test performance with Stanford clinical evaluation data plus real-world pooled surveillance results. It also outlines planned updates or requests for FDA guidance on inclusivity/variant analysis, cross-reactivity and interference expectations for LAMP, endogenous interfering substances, external control concentration rationale, and qualification/lot tracking for RUO reagents. primary file regulatory fl-fda-correspondence 2021-10-20_Response to FDA re QuickColor - EUA210582 10-13.md regulatory/fl-fda-correspondence/2021-10-20_Response to FDA re QuickColor - EUA210582 10-13.md 2021_10_20 gdoc docx CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ 723 1052 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