Identity
- Trade Name
- ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV 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
- P100017 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
- APRL FDA PMA
The Abbott RealTime HCV Assay Kit is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay designed for the quantitation of hepatitis C virus (HCV) RNA in human serum or plasma (EDTA). It is classified under assay, hybridization, and/or nucleic acid amplification for detection of hepatitis C RNA and virus, validated for genotypes 1–6, and intended for use with the Abbott mSample Preparation System reagents and m2000SP/m2000RY4 instruments. The assay measures HCV RNA levels to aid in managing antiviral therapy for HCV-infected patients, including baseline and treatment monitoring.
The kit comprises the Abbott RealTime HCV Amplification Reagent Kit, Control Kit, and Calibrator Kit, supplied as a single-use system for microbiology applications. It requires use with the Abbott m2000 System (m2000SP for sample processing and m2000RT for amplification) and is not intended for donor screening or diagnostic confirmation of HCV infection. The assay is authorized under FDA PMA (P100017) and adheres to regulatory classification 2 (device code MZP, regulation 866.3170). No MRI safety or sterility specifications are noted in the data.
Frequently asked questions
What is the Abbott RealTime HCV Assay Kit used for in clinical practice?
The Abbott RealTime HCV Assay Kit is designed to quantify hepatitis C virus (HCV) RNA levels in human serum or plasma (EDTA) from patients infected with HCV genotypes 1–6. It aids in managing antiviral therapy by measuring viral load at baseline and during treatment, helping predict virological responses to peginterferon alfa-2a/2b plus ribavirin. However, it is not intended for donor screening or diagnostic confirmation of HCV infection.
How is the Abbott RealTime HCV Assay Kit supplied, and what instruments are required for use?
The kit is supplied as a single-use system and includes the Abbott RealTime HCV Amplification Reagent Kit, Control Kit, and Calibrator Kit. It requires use with the Abbott mSample Preparation System reagents and the Abbott m2000SP (for sample processing) and m2000RY4 (for amplification) instruments. The assay is not compatible with standalone testing outside this system.
Can this assay be used to confirm a diagnosis of hepatitis C infection?
No, the Abbott RealTime HCV Assay is explicitly not intended for diagnostic confirmation of HCV infection. Its purpose is quantifying HCV RNA levels to aid in managing antiviral therapy, not to diagnose or rule out infection. Clinical guidelines recommend additional testing for confirmation.
What are the key limitations of the Abbott RealTime HCV Assay in clinical decision-making?
The assay is validated only for patients treated with peginterferon alfa-2a/2b plus ribavirin, so its predictive value for other therapies is unknown. It also lacks established performance for determining the state of HCV infection (e.g., active vs. resolved). Results must be interpreted alongside all clinical and laboratory findings, as the assay alone cannot confirm infection or guide therapy beyond the specified regimen.
How is the regulatory status of this device determined, and what classification does it hold?
The Abbott RealTime HCV Assay holds an FDA Premarket Approval (PMA) under PMA number P100017, classified as a Class II device (product code MZP, regulation 866.3170). This classification reflects its role as an in vitro nucleic acid amplification assay for quantifying HCV RNA, subject to stricter regulatory oversight due to its role in managing antiviral therapy.
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. Sources consulted: PDF Abbott RealTime HCV - molecular.abbott, PDF Abbott RealTime HCV Genotype II - molecular.abbott, PDF Abbott RealTim REFN30-90 HCV Rx Only - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100017 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P100017 24 fields · synced Sep 20, 2026