Identity
- Trade Name
- DIASORIN ETI-AB-COREK PLUS ASSAY FDA PMA
Identifiers
- PMA Number
- P990045 FDA PMA
Classification
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
The ETI-AB-CoreK Plus Assay is an in vitro enzyme immunoassay (EIA) designed for the qualitative detection of total antibodies to hepatitis B core antigen (anti-HBC) in human serum or plasma (collected with EDTA, citrate, or heparin). This assay aids in laboratory diagnosis of exposure to hepatitis B virus (HBV) infection, though further serological testing is required to determine the specific disease state. It is not intended for monitoring HBV disease progression or therapeutic response.
The ETI-AB-CoreK Plus Assay is intended for manual use or with the Biochem Immunosystems Labotech/ETI-LAB automated instrument. It holds an FDA Premarket Approval (PMA P990045) and is supplied as a single-use diagnostic reagent. No specific sterility or storage conditions are stated beyond standard laboratory practices for immunoassay reagents. The device’s performance has not been validated for automated use beyond the specified instrument.
Frequently asked questions
What clinical question does the ETI-AB-CoreK Plus Assay help answer in a patient’s diagnosis?
This assay detects total antibodies to hepatitis B core antigen (anti-HBC) in human serum or plasma, confirming past exposure to the hepatitis B virus (HBV). However, it does not distinguish between active infection, resolved infection, or vaccination status—additional serological testing is required to clarify the specific disease state.
Can this assay be used with automated laboratory systems, and if so, which ones?
Yes, the ETI-AB-CoreK Plus Assay is approved for use with the Biochem Immunosystems Labotech/ETI-LAB automated instrument. However, its performance has not been validated for other automated systems, so compatibility should be confirmed with the manufacturer before use.
Is the ETI-AB-CoreK Plus Assay intended for repeated testing on the same patient over time?
No, the assay is designed for qualitative detection of anti-HBC antibodies to assess exposure to HBV, not for monitoring disease progression or therapeutic response. Further testing would be needed if ongoing clinical assessment is required.
How should the assay reagents be stored, and are they single-use?
The ETI-AB-CoreK Plus Assay is supplied as single-use diagnostic reagents. While specific sterility or storage conditions aren’t detailed beyond standard laboratory practices for immunoassay reagents, it’s critical to follow manufacturer guidelines to maintain assay integrity.
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-COREK PLUS ASSAY (P990045) - Innolitics, ETI-AB-COREK PLUS assay PMA P990045 - FDA.report, DIASORIN ETI-AB-COREK PLUS ASSAY 510 (k) FDA Approval, DIASORIN ETI-AB-EBK PLUS ASSAY (P990041) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990045 | N/A | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P990045 24 fields · synced Sep 18, 2026