Identity
- Trade Name
- EBK FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P870048 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 EBK Hepatitis B Test is an in vitro diagnostic device designed for the detection of Hepatitis B virus markers, including B Antigen (HBsAg), B Surface Antigen, and Be Antigen. Classified under the nomenclature for microbiological assays, it is intended for laboratory use in identifying viral antigens associated with Hepatitis B infection.
This test is supplied as a diagnostic reagent kit and is regulated under FDA Premarket Approval (PMA) with PMA number P870048. It is intended for single-use in clinical microbiology laboratories and adheres to regulatory requirements outlined in 21 CFR 866.3172. Storage and handling conditions are specified in the accompanying instructions, though no additional details are provided in the regulatory data.
Frequently asked questions
What specific Hepatitis B virus markers does the EBK test detect, and how is it intended to be used in a clinical setting?
The EBK Hepatitis B Test detects three key markers: Hepatitis B surface antigen (HBsAg), Hepatitis B surface antigen (B Surface Antigen), and Hepatitis B e antigen (Be Antigen). It is designed exclusively for laboratory use to identify these viral antigens associated with Hepatitis B infection, helping clinicians diagnose or monitor the presence of the virus in patient samples.
Is the EBK Hepatitis B Test intended for single-use, and if so, what does this mean for a laboratory’s workflow?
Yes, the EBK test is intended for single-use only, meaning each kit is designed for one test procedure. This ensures sterility and accuracy per the manufacturer’s specifications, which is critical for reliable diagnostic results. Laboratories must account for this in their workflow by planning for proper disposal of used components and ordering replacement kits as needed.
What regulatory pathway was followed for the approval of the EBK Hepatitis B Test, and what does this imply about its compliance standards?
The EBK Hepatitis B Test was approved through the FDA’s Premarket Approval (PMA) pathway, specifically under PMA number P870048. This pathway is reserved for higher-risk medical devices, indicating that the test has undergone rigorous evaluation to ensure safety, effectiveness, and compliance with regulatory requirements outlined in 21 CFR 866.3172. Clinicians and laboratories can rely on this approval as evidence of the test’s adherence to stringent standards.
How should the EBK test be stored, and are there any specific handling instructions provided by the manufacturer?
While the regulatory data does not provide explicit storage details, the accompanying instructions (as referenced in the description) outline the necessary conditions for storage and handling. Laboratories should follow these instructions closely to maintain the test’s integrity, ensuring proper temperature, humidity, and protection from contamination. Always refer to the manufacturer’s documentation for precise guidance.
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 | P870048 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin
Sources (1)
- FDA PMA P870048 24 fields · synced Sep 18, 2026