> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 1st De Novo Authorization for Covid Test
- URL: https://www.fdaweb.com/1st-de-novo-authorization-for-covid-test/
- Published: 2023-06-06T12:00:00.000Z
- Updated: 2026-09-14T18:36:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154624

FDA has granted a de novo marketing authorization for Cue Health’s Cue Covid-19 Molecular Test, the first at-home Covid test granted a traditional marketing authorization outside of the agency’s emergency use authorities. The molecular nucleic acid amplification test (NAAT) is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection, the agency says.

The test uses the Cue Health app, which displays completed results in about 20 minutes. “In a study reviewed by the FDA, this test correctly identified 98.7% of negative and 92.9% of positive samples in individuals with signs and symptoms of upper respiratory infection,” an agency [release](https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process?ref=fdaweb.com) says.