510(k) · Cleared
ClearedAnti-HCV Next
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Cleared on Sep 23, 2026 as substantially equivalent to P190011 (DiaSorin, Inc., 2019) after an 89-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Sep 23, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- MZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P190011 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backP190011 LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV AbDiaSorin, Inc. · 2019
- This deviceK262156 Anti-HCV NextAbbott Laboratories · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P190011 | LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab | DiaSorin, Inc. | 2019 | — |
| 0 (this device) | K262156 | Anti-HCV Next | Abbott Laboratories | 2026 | — |
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 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 K252424 Anti-HCV Nextscore 11.2 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | P190011 | LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV AbSummary page 6…ssay, Enzyme Linked Immunosorbent, Hepatitis C Virus Governing Regulation: 21 CFR 866.3169 Code: MZO IV. Predicate Device DiaSorin LIAISON XL Murex HCV Ab (P190011) Anti-HCV Next for Alinity i – Pediatric Population 510(k)… | 2019 |
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 no recall.
- 1 other device also cites its predicate P190011.
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. 2026, 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 | — |
What is it indicated for?
The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator…
Read the full statement (139 words)
The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system.
The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease.
Not cleared for use in screening blood, plasma, cell, or tissue donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262156: Anti-HCV Next.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262156
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026