FDA Reclassifies Certain Hepatitis C Diagnostic Tests, Blood Lancets

The US Food and Drug Administration announced on Friday that it has issued two final orders reclassifying certain hepatitis C diagnostic tests from Class III to Class II. Additionally, it reclassified blood lancet devices from Class I to Class II and Class III.

The change applies to nucleic acid-based hepatitis C ribonucleic acid devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, as well as to certain hepatitis C antibody devices intended for the qualitative detection of the virus.

The orders allow these tests to use the agency’s 510(k) clearance pathway instead of the premarket approval pathway, the FDA said in a statement.

Source: https://www.genomeweb.com/molecular-diagnostics/fda-reclassifies-certain-hepatitis-c-diagnostic-tests-blood-lancets#.Ya5tEt-IaUl