Identity
- Trade Name
- DIASORIN ETI-AB-EBK PLUS ASSAY FDA PMA
Identifiers
- PMA Number
- P990041 FDA PMA
Classification
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The ETI-AB-EBK Plus Assay is an in vitro enzyme immunoassay (EIA) designed for the qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human serum or plasma (EDTA, citrate, or heparin). It is classified under microbiology assays and serves as a laboratory tool for identifying seroconversion and progression toward hepatitis B virus (HBV) clearance.
This assay is intended for manual use or with the Biochem Immunosystems Labotech/ETI-LAB automated instrument. It is supplied as a single-use diagnostic reagent and requires further HBV serological marker testing to define the specific disease state. The device holds FDA_PMA authorization under PMA number P990041, with no indication of monitoring HBV disease or therapy performance.
Frequently asked questions
What clinical question does the ETI-AB-EBK Plus assay help answer in hepatitis B virus (HBV) management?
The ETI-AB-EBK Plus assay detects total antibodies to hepatitis B e antigen (anti-HBe) in human serum or plasma, serving as a laboratory marker for seroconversion and progression toward HBV clearance. A reactive result suggests seroconversion, but it does not define the specific disease state—additional HBV serological testing is required to fully assess the patient’s condition. It is not intended for monitoring HBV disease progression or therapy performance.
How is the ETI-AB-EBK Plus assay supplied, and can it be reused?
The ETI-AB-EBK Plus assay is supplied as a single-use diagnostic reagent, meaning each kit is designed for one-time use only. It is not intended for reuse, as single-use diagnostics are engineered to maintain accuracy and sterility for a single test cycle.
Which sample types can be tested with the ETI-AB-EBK Plus assay, and what anticoagulants are compatible?
The assay is designed for use with human serum or plasma collected with EDTA, citrate, or heparin as anticoagulants. It is not compatible with whole blood or other sample types, as specified in its intended use.
Can this assay be used on automated systems, and if so, which ones?
Yes, the ETI-AB-EBK Plus assay is approved for both manual use and automated processing on the Biochem Immunosystems Labotech/ETI-LAB instrument. It is not compatible with other automated platforms unless explicitly stated by the manufacturer.
What regulatory pathway was followed for FDA authorization of the ETI-AB-EBK Plus assay?
The ETI-AB-EBK Plus assay received FDA authorization through the Premarket Approval (PMA) process, with PMA number P990041. This pathway is typically used for higher-risk devices, and the approval was finalized in 2001 after review by the FDA’s Microbiology Devices Advisory Committee (MI).
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: DIASORIN ETI-AB-EBK PLUS ASSAY (P990041) - Innolitics, ETI-AB-EBK PLUS assay PMA P990041 - FDA.report, DIASORIN ETI-AB-EBK PLUS 510 (k) FDA Approval, DIASORIN ETI-EBK PLUS ASSAY (P990043) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990041 | N/A | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P990041 24 fields · synced Sep 18, 2026