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# FDA Wants to Reclassify 2 Hep C Tests
- URL: https://www.fdaweb.com/fda-wants-to-reclassify-2-hep-c-tests/
- Published: 2020-04-01T12:00:00.000Z
- Updated: 2026-09-14T16:09:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146469

FDA says it is proposing to reclassify two types of hepatitis C virus (HCV) diagnostic tests from Class 3 to Class 2\. If the reclassification is finalized, devices of that type could go through the 510(k) pathway instead of the PMA pathway, an agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=318048&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=72502c5e1e3649bf9a6245be2f450c77&elqaid=11883&elqat=1&ref=fdaweb.com) says. As Class 2 devices, the tests would have to comply with special controls to provide a reasonable assurance of safety and effectiveness.

The two types of devices proposed for reclassification are **(1)** nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative and quantitative detection of genotyping of HCV RNA, and **(2)** certain HCV antibody devices intended for the qualitative detection of antibodies to HCV.

The notice includes links to the HCV RNA order and the HCV antibody order.