Identity
- Trade Name
- DIASORIN ETI MAK-2 PLUS ASSAY FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P990038 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 Diasorin ETI-MAK-2 Plus Assay is an in vitro enzyme immunoassay (EIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum or plasma (collected with EDTA, citrate, or heparin). This assay aids in the laboratory diagnosis of hepatitis B virus (HBV) infection, distinguishing between acute and chronic states. It is not intended for monitoring disease progression or therapeutic response, nor is it approved for blood or plasma donor screening.
The ETI-MAK-2 Plus Assay is designed for manual use or with the BioChem ImmunoSystems LabTech/ETI-Lab automated instrument. Supplied as a single-use diagnostic reagent, it requires no sterilisation beyond manufacturer-provided packaging. The device is classified under FDA Product Code LOM and is authorised under PMA number P990038. Compliance with regulatory standards is ensured through FDA approval, with no additional MRI safety or sterility requirements specified beyond standard in vitro diagnostic practices.
Frequently asked questions
What types of samples can the Diasorin ETI-MAK-2 Plus Assay detect hepatitis B surface antigen in, and how should they be collected?
The ETI-MAK-2 Plus Assay is designed to detect hepatitis B surface antigen (HBsAg) in human serum or plasma collected with EDTA, citrate, or heparin. It is not intended for use with whole blood or other sample types. Proper sample collection using these anticoagulants ensures compatibility with the assay’s intended use for qualitative detection of HBV infection.
Is the Diasorin ETI-MAK-2 Plus Assay intended for use with automated systems, and if so, which ones?
Yes, the ETI-MAK-2 Plus Assay is approved for both manual use and automated processing. It is specifically designed to work with the BioChem ImmunoSystems LabTech/ETI-Lab automated instrument, allowing laboratories to streamline testing workflows while maintaining accuracy for qualitative HBsAg detection.
How is the Diasorin ETI-MAK-2 Plus Assay supplied, and is it single-use or reusable?
The ETI-MAK-2 Plus Assay is supplied as a single-use diagnostic reagent, meaning each kit is intended for one test run. No sterilization beyond the manufacturer’s sealed packaging is required, as it is designed for in vitro diagnostic use without additional reprocessing. This ensures consistency and safety for each test.
What regulatory pathway was followed for FDA approval of the Diasorin ETI-MAK-2 Plus Assay, and what does this mean for its use?
The ETI-MAK-2 Plus Assay received FDA approval through a Premarket Approval (PMA) application (PMA number P990038), which is the highest level of regulatory clearance for medical devices in the U.S. This means the assay has undergone rigorous review to confirm its safety and effectiveness for qualitative detection of HBsAg in serum or plasma, though it is not approved for monitoring disease progression or donor screening.
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 | P990038 | Class II | Active |
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Manufacturer
- Manufacturer
- Diasorin Inc.
- FDA Applicant
- DiaSorin, Inc.
Sources (1)
- FDA PMA P990038 24 fields · synced Sep 18, 2026