> ## 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.

# GenePOC Strap A Assay Cleared
- URL: https://www.fdaweb.com/genepoc-strap-a-assay-cleared/
- Published: 2019-03-21T12:00:00.000Z
- Updated: 2026-09-15T01:14:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143666

FDA has cleared a GenePOC 510(k) for the GenePOC Strep A assay for use on its revogene device. The qualitative *in vitro* diagnostic test is intended for detecting *Streptococcus pyogenes* nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The assay can provide results as early as 42 minutes for positive specimens and in approximately 70 minutes for negative specimens, without the need for culture confirmation, according to the company.