PMA · Approved
ApprovedARCHITECT Anti-HCV / Alinity i Anti-HCV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories, Inc. · MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Approved on Dec 15, 2021 through premarket approval, which rests on the device’s own clinical evidence after a 27-day review.
- Decided
- Dec 15, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- MZO
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MZO? 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 MZO device
- #1 K262156 Anti-HCV Nextscore 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
How does its category compare?
All MZO devicesMZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MZO
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MZO
Too few MZO 510(k)s in any year since 2007 to give a median.
Recalls per year · MZO
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MZO
208in 2025
MAUDE reports naming product code MZO, 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 | 20 |
| 2008 | 3 | — | 0 | 21 |
| 2009 | 11 | — | 0 | 86 |
| 2010 | 12 | — | 0 | 51 |
| 2011 | 40 | — | 0 | 76 |
| 2012 | 24 | — | 0 | 136 |
| 2013 | 16 | — | 0 | 119 |
| 2014 | 10 | — | 0 | 57 |
| 2015 | 14 | — | 0 | 41 |
| 2016 | 19 | — | 0 | 115 |
| 2017 | 16 | — | 0 | 116 |
| 2018 | 17 | — | 0 | 153 |
| 2019 | 11 | — | 0 | 138 |
| 2020 | 13 | — | 0 | 47 |
| 2021 | 8 | — | 0 | 26 |
| 2022 | 0 | — | 0 | 56 |
| 2023 | 1 | — | 0 | 55 |
| 2024 | 0 | — | 0 | 56 |
| 2025 | 0 | — | 0 | 208 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P050042/S047 · printed Nov 5, 2026
Cite this page
510(k) Report. “P050042/S047: ARCHITECT Anti-HCV / Alinity i Anti-HCV.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P050042/S047
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026