PMA · Approved
ApprovedLIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Approved on Oct 18, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 179-day review. 2 later devices descend from it.
- Decided
- Oct 18, 2019
- Review
- 179 days
- Class
- Class II
- Product code
- MZO
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P190011 | LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab | DiaSorin, Inc. | 2019 | — |
| +1 | K262156 | Anti-HCV Next | Abbott Laboratories | 2026 | — |
| +1 | K252424 | Anti-HCV Next | Abbott Laboratories | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K262156 (Abbott Laboratories, 2026) has gone furthest, with 0 descendants of its own.
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. 2019, 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/P190011 · printed Nov 6, 2026
Cite this page
510(k) Report. “P190011: LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P190011
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026