# K252102: Alinity m HCV

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular, Inc.
- Decided: Sep 25, 2025 after 84 days
- Product code: 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
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P190025 (2020). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P190025: Alinity m HCV, Abbott Molecular, Inc. (2020) Summary page 6.

## Indications for use
The Alinity m HCV 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 Sustained Virologic Response (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.

Source page: https://510kreport.com/device/K252102
Methodology: https://510kreport.com/methodology