| K-number | K252102 |
| Device name | Alinity m HCV |
| Applicant | Abbott Molecular, Inc. |
| Product code | MZP |
| Device class | Class II |
| Decision date | Sep 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3170 |
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) test that detects and quantifies hepatitis C virus RNA in human plasma or serum samples from HCV antibody-positive individuals. The test is used by clinical laboratories to aid in diagnosis of active HCV infection and to monitor patients with known HCV infection, including assessment of treatment response (Sustained Virologic Response). The assay is not intended for screening of blood or tissue donors.
The device uses reverse transcription-polymerase chain reaction (RT-PCR) technology to detect and quantify HCV RNA in patient samples. The assay processes EDTA or Acid Citrate Dextrose plasma and serum specimens. The test provides both qualitative detection and quantitative measurement of viral RNA levels.
Not stated.
View the full FDA submission: accessdata.fda.gov