Identity
- Trade Name
- DIASORIN ETI-EBK PLUS ASSAY FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P990043 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 ETI-EBK Plus Assay is an in vitro diagnostic test classified under microbiology, designed for the qualitative detection of hepatitis B e antigen (HBeAg) in human serum or plasma (collected with EDTA, citrate, or heparin). This assay aids in identifying active hepatitis B virus (HBV) replication, which typically correlates with viremia, and serves as presumptive laboratory evidence of HBV infection. Further serological testing is required to define the specific disease state, though the assay is not intended for monitoring HBV disease progression or therapy.
The ETI-EBK Plus Assay is intended for manual use or with the BioChem ImmunoSystems LabTech/ETI-Lab automated instrument. Supplied as a single-use diagnostic test, it is not sterile but is intended for laboratory use under controlled conditions. The device is regulated under FDA Premarket Approval (PMA) and falls under classification II (device class 2) for in vitro diagnostic tests, with regulatory designation 866.3172. Storage and handling must comply with manufacturer guidelines to ensure test validity.
Frequently asked questions
What types of samples can the ETI-EBK Plus Assay detect hepatitis B e antigen in, and why is this important for testing?
The ETI-EBK Plus Assay is designed to detect hepatitis B e antigen (HBeAg) in human serum or plasma collected with EDTA, citrate, or heparin. This specificity is important because HBeAg is a marker of active hepatitis B virus (HBV) replication, often linked to viremia, which helps clinicians identify active infection. However, the assay is not intended for monitoring disease progression or therapy, so additional serological testing is required to fully define the patient’s disease state.
Is the ETI-EBK Plus Assay meant for automated or manual use, and how does this affect its implementation in a lab?
The ETI-EBK Plus Assay is approved for both manual use and automated processing on the BioChem ImmunoSystems LabTech/ETI-Lab instrument. This flexibility allows labs to choose the workflow that best fits their workflow—manual testing for smaller volumes or automated systems for higher throughput—while maintaining consistent performance and compliance with manufacturer guidelines.
Is the ETI-EBK Plus Assay single-use, and if so, what does this mean for lab workflows and sterility?
Yes, the ETI-EBK Plus Assay is supplied as a single-use diagnostic test. While it is not sterile, it is intended for laboratory use under controlled conditions, meaning it does not require sterile handling like surgical instruments but must be used in a clean environment to prevent contamination and ensure accurate results. Single-use design also reduces the risk of cross-contamination between samples.
What regulatory pathway does the ETI-EBK Plus Assay follow, and what does this imply for its use in clinical settings?
The ETI-EBK Plus Assay follows the FDA Premarket Approval (PMA) pathway, which ensures rigorous evaluation of its safety and effectiveness before clinical use. This approval status implies that the assay has been thoroughly validated for its intended purpose—qualitative detection of HBeAg in serum or plasma—making it a reliable tool for identifying active HBV replication in controlled laboratory settings. Clinicians can trust its performance for initial screening, though further testing is still required for comprehensive disease assessment.
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 | P990043 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P990043 24 fields · synced Sep 18, 2026