PMA · Approved
Recalled · Class II · 2024Architect Anti-HCV Assay; Architect Anti-HCV Calibrator; Architect Anti-HCV Control
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 Jun 7, 2006 through premarket approval, which rests on the device’s own clinical evidence after a 196-day review. It has been recalled 3 times.
- Decided
- Jun 7, 2006
- Review
- 196 days
- Class
- Class II
- Product code
- MZO
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P050042 has 47 supplements since 2006: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 2 |
| 2011 | 10 |
| 2012 | 6 |
| 2013 | 7 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 3 |
| 2019 | 3 |
| 2020 | 5 |
| 2021 | 3 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2024 | Class II | Z-1479-2024 | Device Design | Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as… |
| Mar 4, 2024 | Class II | Z-1480-2024 | Device Design | Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as… |
| Jan 2, 2007 | Not classified | Z-0413-2007 | Other | The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the ARCHITECT AUSAB Reagent Package… |
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.
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 · printed Nov 6, 2026
Cite this page
510(k) Report. “P050042: Architect Anti-HCV Assay; Architect Anti-HCV Calibrator; Architect Anti-HCV Control.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P050042
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026