510(k) · Cleared
Clearedcobas HCV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Cleared on Nov 3, 2025 as substantially equivalent to K221007 (Roche Molecular Systems, Inc., 2022) after an 88-day review. Its family tree reaches back 2 generations to 2015.
- Decided
- Nov 3, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- MZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P150015 (2015). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K252102 Alinity m HCVscore 10.1 · 1 generation · 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 |
|---|---|---|---|
| * | K221007 | cobas HCVSummary page 5…ITIS C RNA, HEPATITIS C VIRUS Product Codes MZP, 21 CFR 866.3170 Predicate Devices cobas® HCV for use on the cobas® 5800/6800/8800 Systems (K221007) Establishment Registration Roche Molecular Systems, Inc. (2243471) 1. DEVICE DESCRIPTION cobas® HCV is a quantit… | 2022 |
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?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors 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?
cobas HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. cobas HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of…
Read the full statement (241 words)
cobas HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay.
cobas HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.
cobas HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings.
cobas HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products.
Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252484 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252484: cobas HCV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252484
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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