Identity
- Trade Name
- AXSYM, AUSAB FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P060003 FDA PMA
- FDA Product Code
- LOM FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3172 FDA PMA
- Regulation Number
- 866.3172 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The AXSYM AUSAB is a Microparticle Enzyme Immunoassay (MEIA) intended for the quantitative determination of antibody to Hepatitis B surface antigen (Anti-HBS) in serum or plasma. It is classified under microbiology assays and used to measure immune response to Hepatitis B Virus (HBV) vaccination, as well as to assess HBV immune status when combined with additional laboratory findings and clinical evaluation.
The AXSYM AUSAB is supplied as a reagent pack for use on the AXSYM system, requiring calibration with AXSYM AUSAB Standard Calibrators and performance monitoring with AXSYM AUSAB Controls. It is intended for in vitro diagnostic use in clinical laboratory settings and has received FDA Premarket Approval (PMA). The device operates within Class II regulatory classification and is authorized under product code LOM, regulation number 866.3172.
Frequently asked questions
What is the AXSYM AUSAB used for in clinical practice and how does it differ from other Hepatitis B tests?
The AXSYM AUSAB is a Microparticle Enzyme Immunoassay (MEIA) specifically designed for the quantitative measurement of anti-HBs antibodies in serum or plasma. It helps assess immune response to Hepatitis B Virus (HBV) vaccination and evaluate HBV immune status when combined with other lab results and clinical evaluation. Unlike qualitative tests, this assay provides numerical values, allowing precise tracking of antibody levels post-vaccination or infection. It is not intended for standalone diagnosis of HBV disease but requires correlation with additional clinical findings.
How is the AXSYM AUSAB supplied, and what additional components are required for use?
The AXSYM AUSAB comes as a reagent pack for use exclusively on the AXSYM system. To operate the assay, you must also use AXSYM AUSAB Standard Calibrators (for system calibration) and AXSYM AUSAB Controls (for performance monitoring). These components are not interchangeable with other anti-HBs assays, as their performance has not been validated elsewhere. The system requires these specific calibrators and controls to ensure accurate quantitative results.
Can the AXSYM AUSAB be used with pediatric samples, and what sample types are compatible?
Yes, the AXSYM AUSAB is approved for use with both adult and pediatric serum, including samples collected in serum separator tubes, as well as sodium heparin plasma. This flexibility makes it suitable for testing across all age groups, though results should always be interpreted alongside clinical context and other diagnostic tests for accurate HBV immune status assessment.
Is the AXSYM AUSAB single-use or reusable, and how should it be stored?
The AXSYM AUSAB reagent pack is designed for single-use per assay run on the AXSYM system. Storage conditions are not explicitly detailed in the provided data, but typical MEIA reagents require protection from extreme temperatures, light, and moisture. Laboratories should follow the manufacturer’s instructions (available in the accompanying documentation) for optimal shelf life and handling to maintain assay validity.
What regulatory pathway was followed for the AXSYM AUSAB, and what classification does it hold?
The AXSYM AUSAB received FDA Premarket Approval (PMA) under product code LOM (Microbiology) and regulation number 866.3172, classifying it as a Class II device. This pathway ensures rigorous evaluation of its safety and performance for quantitative anti-HBs measurement. The approval specifically authorizes its use on the AXSYM system with the required calibrators and controls, as outlined in the AO statement.
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 | P060003 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA PMA P060003 24 fields · synced Sep 18, 2026