VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR FDA PMA
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA
Identifiers
- PMA Number
- P030024 FDA PMA
- FDA Product Code
- SEI FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3173 FDA PMA
- Regulation Number
- 866.3173 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator are in vitro diagnostic devices designed for the qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total Anti-HBc) in human serum and plasma (EDTA and citrate), including neonate serum. These assays are intended for use with the VITROS ECI Immunodiagnostic System to aid in the laboratory diagnosis of hepatitis B infection, including acute, chronic, or recovery phases, and to assess prior exposure to HBV in unvaccinated individuals.
The Anti-HBc Reagent Pack is supplied as a single-use component for the VITROS ECI system, while the Anti-HBc Calibrator is used to calibrate the system when performing these assays. Both components are intended for use in clinical microbiology laboratories and are regulated under an FDA Premarket Approval (PMA). The devices are not MRI-compatible and must be stored according to manufacturer instructions to maintain performance integrity.
Frequently asked questions
What clinical scenarios is the VITROS Anti-HBc Reagent Pack designed to support in patient diagnosis or monitoring?
The VITROS Anti-HBc Reagent Pack is intended to aid in the laboratory diagnosis of hepatitis B infection across different phases—acute, chronic, or recovery—by qualitatively detecting total antibody (IgG and IgM) to hepatitis B core antigen in human serum and plasma (including EDTA and citrate) as well as neonate serum. It also helps assess prior exposure to HBV in unvaccinated individuals, providing critical serological data when combined with clinical information.
How is the VITROS Anti-HBc Reagent Pack supplied, and is it reusable?
The VITROS Anti-HBc Reagent Pack is supplied as a single-use component specifically designed for the VITROS ECI Immunodiagnostic System. This means each pack is intended for one-time use only, ensuring consistency and sterility for accurate assay results. Reuse is not recommended or supported by the manufacturer.
What sample types can be tested using this reagent pack, and are there any special handling requirements?
The VITROS Anti-HBc Reagent Pack is designed to work with human adult and pediatric serum, plasma (EDTA and citrate), and neonate serum. No additional special handling requirements are specified beyond adhering to standard laboratory protocols for sample preparation and storage, as outlined in the manufacturer’s instructions to maintain performance integrity.
What role does the Anti-HBc Calibrator play in the testing process, and how is it used?
The Anti-HBc Calibrator is used exclusively to calibrate the VITROS ECI Immunodiagnostic System when performing qualitative detection of total Anti-HBc. It ensures the system’s accuracy and reliability by providing a reference standard for the assays conducted with the Anti-HBc Reagent Pack, which is critical for consistent and reproducible results across tests.
Are there any storage or environmental conditions that must be followed to maintain the performance of these devices?
The manufacturer specifies that the VITROS Anti-HBc Reagent Pack and Calibrator must be stored according to their instructions to preserve performance integrity. While exact conditions aren’t detailed in the provided data, typical in vitro diagnostic devices require protection from extreme temperatures, light, and contamination. Always refer to the manufacturer’s guidelines for precise storage protocols.
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: QuidelOrtho - Technical Documents
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P030024 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA PMA P030024 24 fields · synced Oct 6, 2026