Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Basic Information
- Device Name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Trade Name
- Alinity m HCV
- PMA Number
- P190025
- Device Class
- FDA Class 2
- Product Code
- MZP
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Regulation Number
- 866.3170
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- March 23, 2020
- Date Received
- September 30, 2019
- Expedited Review
- N
- Docket Number
- 20M-1175
Advisory Committee Statement
Approval for the Alinity m HCV. The assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including SVR determination.The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | FDA class 2 | Microbiology |