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# HIV Resistance Assay Put in Class 2
- URL: https://www.fdaweb.com/hiv-resistance-assay-put-in-class-2/
- Published: 2020-02-07T12:00:00.000Z
- Updated: 2026-09-14T16:02:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146040

*Federal Register* notice: FDA has classified human immunodeficiency virus (HIV) drug resistance genotyping assays using next generation sequencing (NGS) technology into Class 2 (special controls). The action is in response to a 3/19 de novo classification request by Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay. The agency has identified the assay as a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-02-07/pdf/2020-01725.pdf?ref=fdaweb.com).