PMA · Approved
Recalled · 2011Cobas Ampliprep/Cobas Taqman HCV Test
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
Approved on Oct 30, 2008 through premarket approval, which rests on the device’s own clinical evidence after a 734-day review. It has been recalled 2 times.
- Decided
- Oct 30, 2008
- Review
- 734 days
- Class
- Class II
- Product code
- MZP
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P060030 has 83 supplements since 2008: 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 |
|---|---|
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 7 |
| 2011 | 6 |
| 2012 | 7 |
| 2013 | 9 |
| 2014 | 6 |
| 2015 | 4 |
| 2016 | 8 |
| 2017 | 6 |
| 2018 | 10 |
| 2019 | 10 |
| 2020 | 3 |
| 2021 | 2 |
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 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 K252484 cobas HCVscore 10.6 · 2 generations · 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 |
|---|---|---|---|---|
| Apr 14, 2011 | Not classified | Z-2587-2011 | Other | The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches. |
| Apr 14, 2011 | Not classified | Z-2586-2011 | Other | The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches. |
No ancestor or descendant has a Class I 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. 2008, 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 | — |
https://510kreport.com/device/P060030 · printed Nov 4, 2026
Cite this page
510(k) Report. “P060030: Cobas Ampliprep/Cobas Taqman HCV Test.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P060030
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026