Identity
- Trade Name
- ABBOTT REALTIME HBV ASSAY FDA PMA
- Generic Name
- Hepatitis Viral B DNA Detection FDA PMA
Identifiers
- PMA Number
- P080026 FDA PMA
- FDA Product Code
- MKT FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3174 FDA PMA
- Regulation Number
- 866.3174 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Abbott Realtime HBV Assay is an in vitro polymerase chain reaction (PCR) test designed for quantifying Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically infected individuals. It operates within the Abbott M2000 System using DNA reagents and is intended for use with the Abbott M200SP or M200RT instruments. This assay aids in monitoring HBV DNA levels at baseline and during antiviral therapy to assess treatment response in patients with chronic HBV infection.
The assay is supplied as a single-use reagent kit, requiring validation through the Abbott Realtime HBV Control Kit and calibration with the Abbott Realtime HBV Calibrator Kit. It is classified under FDA’s Device Class II (866.3174) and is approved for microbiology applications. Storage and handling conditions are specified in the accompanying documentation, though no additional regulatory status beyond PMA approval (P080026) is implied beyond what is explicitly stated.
Frequently asked questions
What clinical scenarios is the Abbott Realtime HBV Assay specifically designed to support in patient management?
The assay is intended for quantifying Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically infected individuals to monitor HBV DNA levels at baseline and during antiviral therapy. It aids in assessing treatment response in patients undergoing antiviral therapy for chronic HBV infection, specifically those treated with adefovir dipivoxil, though its performance for determining the clinical stage of HBV infection has not been established.
How is the Abbott Realtime HBV Assay supplied, and what additional components are required for proper use?
The assay is supplied as a single-use reagent kit for use with the Abbott M2000 System’s DNA reagents and the Abbott M200SP or M200RT instruments. To ensure accurate results, it must be validated using the Abbott Realtime HBV Control Kit and calibrated with the Abbott Realtime HBV Calibrator Kit, both of which are designed for quantifying HBV DNA in serum or plasma (EDTA).
Can this assay be used for screening blood products or confirming HBV infection in patients?
No, the assay is explicitly not intended for use as a screening test in blood or blood products for HBV, nor is it designed to confirm the presence of HBV infection. Its purpose is limited to quantifying HBV DNA in chronically infected individuals to monitor treatment response during antiviral therapy.
What instruments are compatible with the Abbott Realtime HBV Assay, and how does it integrate into the workflow?
The assay operates exclusively within the Abbott M2000 System, specifically designed for use with the Abbott M200SP or M200RT instruments. It requires DNA reagents and is validated for quantifying HBV DNA in human serum or plasma (EDTA) from chronically infected patients, making it a specialized tool for laboratories already equipped with these systems.
What regulatory pathway was followed for approval of this assay, and what class does it fall under?
The assay received FDA PMA approval under the designation P080026, classifying it as a Class II medical device (product code MKT, FDA classification 866.3174). This pathway ensures it meets stringent performance standards for quantifying HBV DNA in clinical settings, though no additional regulatory status beyond this approval is implied.
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 | P080026 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P080026 24 fields · synced Sep 18, 2026