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# HIV Tests Down Classified to 510(k)
- URL: https://www.fdaweb.com/hiv-tests-down-classified-to-510-k/
- Published: 2022-05-13T12:00:00.000Z
- Updated: 2026-09-14T17:44:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151809

*Federal Register* notice: FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, which are postamendments Class 3 devices with the product code MZF, into Class 2 (special controls), subject to premarket notification. The reclassification will reduce the regulatory burdens associated with these device types, as manufacturers will no longer be required to submit a PMA and instead now can submit a 510(k). To view the notice, click [here](https://public-inspection.federalregister.gov/2022-10461.pdf?ref=fdaweb.com).