Cobas Amplicor Hcv Test And Cobas Ampliprep/Cobas Amplicor Hcv Test Version 2.0
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 FDA PMA
- Generic Name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus FDA PMA
Identifiers
- PMA Number
- P000012 FDA PMA
- FDA Product Code
- MZP FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3170 FDA PMA
- Regulation Number
- 866.3170 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The Cobas Amplicor Hepatitis C Virus Test Version 2.0 is an assay, hybridization, and nucleic acid amplification device for the qualitative detection of hepatitis C virus (HCV) RNA in human serum or EDTA plasma. It employs reverse transcription of target HCV RNA into cDNA, followed by polymerase chain reaction (PCR) amplification and hybridization with an enzyme-labeled oligonucleotide probe to generate a detectable colored signal via the Cobas Amplicor Analyzer.
This in vitro diagnostic device is intended for use in clinical microbiology laboratories to confirm active HCV infection in patients with evidence of liver disease and prior antibody testing. Supplied as a single-use reagent system, it requires FDA_PMA authorization (PMA Number: P000012) and is classified under device class 2 (product code: MZP). Sterility and handling instructions are specified in the accompanying documentation, with storage conditions detailed for reagent stability.
Frequently asked questions
What is the primary clinical purpose of the COBAS AMPLICOR HCV Test Version 2.0, and how does it differ from antibody testing for HCV?
The COBAS AMPLICOR HCV Test Version 2.0 is designed to confirm active hepatitis C virus (HCV) infection by detecting HCV RNA in human serum or EDTA plasma. Unlike antibody tests, which only indicate past or current exposure to the virus, this test specifically identifies replicating HCV RNA, proving the virus is actively present and causing infection. It is intended for patients who already show evidence of liver disease and prior HCV antibody positivity, helping to distinguish between active infection and resolved or latent cases.
Is the COBAS AMPLICOR HCV Test Version 2.0 intended for use in all clinical settings, or is it laboratory-specific?
The test is explicitly intended for use in clinical microbiology laboratories only. It requires specialized equipment (the Cobas Amplicor Analyzer) and trained personnel to perform reverse transcription, PCR amplification, and hybridization. The assay is not designed for point-of-care or home-use settings, as it involves complex nucleic acid amplification and detection processes that must be conducted under controlled laboratory conditions.
How is the COBAS AMPLICOR HCV Test Version 2.0 supplied, and what considerations should be made for its use?
The test is supplied as a single-use reagent system, meaning each kit is designed for one test run. This ensures sterility and prevents cross-contamination between samples. Since it is classified as a sterile in vitro diagnostic device, proper handling and storage per manufacturer instructions are critical to maintain reagent stability and test validity. The accompanying documentation outlines specific sterility and storage requirements to preserve the assay’s performance.
What types of blood samples can be used with the COBAS AMPLICOR HCV Test Version 2.0, and are there any restrictions?
The test is authorized for use with human serum or EDTA plasma collected from blood samples. EDTA plasma is explicitly mentioned as a valid specimen type, while other anticoagulants (e.g., heparin or citrate) are not approved for this assay. The test is not intended for whole blood or other sample types, and proper sample collection and handling (e.g., avoiding hemolysis) are essential for accurate results.
What regulatory pathway was followed for the approval of the COBAS AMPLICOR HCV Test Version 2.0, and what does this mean for its use?
The test underwent FDA Premarket Approval (PMA) through the traditional review process, as indicated by the PMA number (P000012). This means the device was evaluated for safety and effectiveness through a rigorous scientific and clinical review before approval. Clinicians and laboratories must ensure they are using a legally marketed version of the test (e.g., the Version 2.0) and follow all FDA-authorized protocols, including proper training and compliance with laboratory standards, to maintain regulatory compliance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P000012 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P000012 24 fields · synced Sep 18, 2026