Identity
- Trade Name
- Elecsys Anti-HBe, PreciControl Anti-HBe FDA PMA
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA
Identifiers
- PMA Number
- P190005 FDA PMA
- FDA Product Code
- SEI FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3173 FDA PMA
- Regulation Number
- 866.3173 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Elecsys Anti-HBe is an immunoassay for the in vitro qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human serum or plasma. It is designed to aid in the diagnosis of hepatitis B virus (HBV) infection in individuals exhibiting symptoms of hepatitis or at risk of HBV exposure. A reactive result indicates presumptive evidence of HBV seroconversion, requiring further serological testing to clarify the disease state.
This device is intended for use on the cobas e 602 immunoassay analyzer and is supplied as a reagent kit for laboratory testing. It is classified as a Class II medical device under FDA regulations (866.3173) and requires quality control using the included PreciControl Anti-HBe. The assay is not validated for use with other anti-HBe testing systems.
Frequently asked questions
What types of samples can the Elecsys Anti-HBe test, and how should they be prepared for analysis?
The Elecsys Anti-HBe immunoassay is designed for use with human serum or plasma collected using potassium EDTA, lithium heparin, sodium citrate, or sodium heparin as anticoagulants. No additional preparation is required beyond standard serum/plasma separation procedures. The assay is not validated for use with whole blood or other sample types.
Is the Elecsys Anti-HBe assay compatible with other testing platforms, or is it exclusive to the cobas e 602?
The Elecsys Anti-HBe is specifically designed for use only on the cobas e 602 immunoassay analyzer. Roche Diagnostics has not validated its performance with any other anti-HBe testing systems, so cross-platform use is not supported.
What does a reactive result on the Elecsys Anti-HBe indicate, and what follow-up testing is recommended?
A reactive result on the Elecsys Anti-HBe indicates presumptive evidence of hepatitis B virus (HBV) seroconversion, meaning the patient’s immune system has likely developed antibodies in response to prior HBV infection or exposure. However, this result alone does not define the specific disease state. The manufacturer advises further HBV serological marker testing (e.g., HBsAg, HBeAg, HBV DNA) to clarify the infection status and guide clinical management.
How is quality control ensured when using the Elecsys Anti-HBe on the cobas e 602?
Quality control for the Elecsys Anti-HBe is performed using the included PreciControl Anti-HBe, which must be used as directed on the cobas e 602 analyzer. This control ensures assay performance meets specifications, but its use is not validated for any other anti-HBe testing systems. Regular monitoring with PreciControl is required to maintain test accuracy.
Are there specific storage requirements for the Elecsys Anti-HBe reagent kit or its controls?
While the exact storage conditions are not detailed in the provided data, typical immunoassay reagents like the Elecsys Anti-HBe kit and its PreciControl require refrigeration (usually between 2°C and 8°C) to maintain stability. Always refer to the included instructions for use (IFU) for precise storage instructions, as improper handling could compromise test validity.
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 | P190005 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA PMA P190005 24 fields · synced Sep 18, 2026