FDA product code MZP: Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
MZP is the FDA product code for assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus. It is a Class II device, regulated under 21 CFR 866.3170 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under MZP, 4 in the last five years, from 3 different applicants. The average 510(k) review took 171 days (median 150); 192 days on average over the last three years. 9 PMA applications cite this product code. FDA has posted 11 recalls for MZP devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3170 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for MZP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 213 |
| 2024 | 1 | 299 |
| 2025 | 2 | 86 |
Compare with all 510(k) review times · Search every MZP clearance
Top MZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Molecular Systems, Inc. | 2 | 2025-11-03 |
| Abbott Molecular, Inc. | 1 | 2025-09-25 |
| Hologic, Inc. | 1 | 2024-07-24 |
Most recent MZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252484 | Roche Molecular Systems, Inc. | cobas HCV | 2025-11-03 | 88 |
| K252102 | Abbott Molecular, Inc. | Alinity m HCV | 2025-09-25 | 84 |
| K233352 | Hologic, Inc. | Aptima HCV Quant Dx Assay | 2024-07-24 | 299 |
| K221007 | Roche Molecular Systems, Inc. | cobas HCV | 2022-11-04 | 213 |
Recalls for MZP devices
11 product recalls in 9 recall events; 6 initiated in the last five years and 4 still open. Most recent: 2023-10-30.
| Year | Recalls |
|---|---|
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code MZP?
MZP is the FDA product code for assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus. It is a Class II device, regulated under 21 CFR 866.3170 and reviewed by the Microbiology panel.
What device class is MZP?
Class II, regulation 21 CFR 866.3170. Typical premarket route: 510(k).
How long does a 510(k) take for product code MZP?
Across 4 cleared submissions the average was 171 days from receipt to decision (median 150).
Which companies have the most MZP clearances?
Roche Molecular Systems, Inc. (2); Abbott Molecular, Inc. (1); Hologic, Inc. (1).
Have MZP devices been recalled?
Yes: 11 product recalls across 9 recall events; the most recent began 2023-10-30.
Next steps
- Run an FDA pathway report with predicate devices for product code MZP
- Run a recall and safety report across every MZP manufacturer
- Watch product code MZP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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