510(k) · Cleared
ClearedAlinity m HCV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Cleared on Sep 25, 2025 as substantially equivalent to P190025 (Abbott Molecular, Inc., 2020) after an 84-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Sep 25, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- MZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P190025 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backP190025 Alinity m HCVAbbott Molecular, Inc. · 2020 · Recalled
- This deviceK252102 Alinity m HCVAbbott Molecular, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P190025 | Alinity m HCV | Abbott Molecular, Inc. | 2020 | 5 |
| 0 (this device) | K252102 | Alinity m HCV | Abbott Molecular, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MZP device
- #1 K252484 cobas HCVscore 10.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P190025 | Alinity m HCVSummary page 6…redicate Device Device Name Predicate Device PMA Approved Alinity m HCV Alinity m HCV P190025 03/23/2020 Alinity m HCV 510(k) K252102 September 2025 Attachment 022_Alinity m HCV_510(k) Summary_mw006… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All MZP devicesMZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MZP
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MZP
Too few MZP 510(k)s in any year since 2007 to give a median.
Recalls per year · MZP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MZP
12in 2025
MAUDE reports naming product code MZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 1 | 0 |
| 2008 | 12 | — | 0 | 6 |
| 2009 | 11 | — | 0 | 12 |
| 2010 | 19 | — | 0 | 11 |
| 2011 | 20 | — | 2 | 44 |
| 2012 | 17 | — | 0 | 26 |
| 2013 | 24 | — | 0 | 36 |
| 2014 | 12 | — | 0 | 13 |
| 2015 | 12 | — | 0 | 1 |
| 2016 | 21 | — | 0 | 12 |
| 2017 | 15 | — | 0 | 5 |
| 2018 | 30 | — | 0 | 4 |
| 2019 | 35 | — | 0 | 5 |
| 2020 | 18 | — | 0 | 1 |
| 2021 | 8 | — | 4 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (127 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252102: Alinity m HCV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252102
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026