Elecsys HBeAg Immunoassay and PreciControl HBeAg
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P130015 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
- APRL FDA PMA
The Elecsys HBeAg Immunoassay is an in vitro qualitative immunoassay intended for the detection of Hepatitis B e antigen (HBeAg) in human serum or plasma. It employs electrochemiluminescence immunoassay (ECLIA) technology and is designed for use on the Modular Analytics E170 analyzer. The PreciControl HBeAg serves as a quality control reagent for the HBeAg assay, ensuring accurate performance of the diagnostic test.
This device is supplied as a reagent kit for laboratory use and is intended for single-use per test. It is classified as a Class II medical device under FDA regulations and requires compliance with the specified quality control measures. The assay is authorized under FDA PMA (P130015) and is intended for use in microbiology settings to aid in the laboratory diagnosis of acute or chronic Hepatitis B infection or recovery from infection, in conjunction with other serological and clinical information.
Frequently asked questions
What types of patient samples can the Elecsys HBeAg Immunoassay test, and why is this important for clinical use?
The Elecsys HBeAg Immunoassay is designed to detect Hepatitis B e antigen (HBeAg) in human serum or plasma collected with K2-EDTA, lithium or sodium heparin, or sodium citrate. This flexibility is important because it allows laboratories to use samples already collected for other tests, reducing the need for additional venipuncture and improving workflow efficiency. The assay is specifically authorized for adult patients with symptoms of hepatitis or those at risk for HBV infection, ensuring compatibility with common clinical sample types.
How is the Elecsys HBeAg Immunoassay supplied, and is it intended for single-use or reusable testing?
The Elecsys HBeAg Immunoassay is supplied as a reagent kit for laboratory use, intended exclusively for single-use per test. This design minimizes cross-contamination risks and ensures accurate, consistent results for each patient sample. The accompanying PreciControl HBeAg is also single-use, serving as a quality control reagent to verify assay performance on the Modular Analytics E170 analyzer.
What analyzer is required to run the Elecsys HBeAg Immunoassay, and does this limit its compatibility with other lab systems?
The Elecsys HBeAg Immunoassay is exclusively intended for use on the Modular Analytics E170 analyzer by Roche Diagnostics. This specificity ensures optimized performance and calibration of the assay, as the ECLIA technology is tailored to the analyzer’s automated workflow. Laboratories without this system would need to invest in the analyzer or use alternative HBeAg testing methods.
What role does the PreciControl HBeAg play in the testing process, and why is it necessary?
The PreciControl HBeAg serves as a quality control reagent for the Elecsys HBeAg Immunoassay, ensuring the assay performs accurately and reliably on the Modular Analytics E170 analyzer. It helps laboratories validate test results by confirming the system’s calibration and detecting potential errors before patient samples are processed. This step is critical for maintaining diagnostic confidence and compliance with clinical laboratory standards.
Are there specific storage requirements for the Elecsys HBeAg Immunoassay kit, and if so, how might this affect laboratory workflow?
While the exact storage conditions are not detailed in the provided data, the assay is classified as a laboratory reagent kit and must be stored according to Roche Diagnostics’ guidelines (typically refrigerated or at room temperature, as specified in the accompanying documentation). Laboratories should verify the manufacturer’s instructions to avoid degradation, which could impact assay sensitivity or specificity. Proper storage ensures consistent performance and minimizes waste from expired or compromised reagents.
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 | P130015 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Operations, Inc.
Sources (1)
- FDA PMA P130015 24 fields · synced Oct 6, 2026