# MZP: Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

- Device class: 2; regulation: 21 CFR 866.3170; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 151 days (middle half 87–235)
- Recalls: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 12
- 2016: 21
- 2017: 15
- 2018: 30
- 2019: 35
- 2020: 18
- 2021: 8
- 2022: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- P190025: Alinity m HCV (2020), cited by 1
- P160023: Aptima HCV Quant DX Assay (2017), cited by 1
- K221007: cobas HCV (2022), cited by 1
- P150015: Cobas HCV Test (2015), cited by 1

Source page: https://510kreport.com/product-code/MZP
Data by year (CSV): https://510kreport.com/product-code/MZP.csv