Elecsys Anti-HBS Test System
PMA P010054
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP010054 | Date28 Feb 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Elecsys Anti-Hbs
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- PMA Number
- FDA Product Code
- SEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3173
- Advisory Committee
- Microbiology
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Elecsys Anti-HBS Test System is a qualitative and quantitative hepatitis B virus antibody assay designed for the detection of total antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA). This electrochemiluminescence immunoassay (ECLIA) operates on the Roche Elecsys 2010 immunoassay analyzer, enabling precise serological testing for hepatitis B virus (HBV) markers. Results assist in determining susceptibility to HBV infection, monitoring post-vaccination status, and aiding in the differential diagnosis of hepatitis when etiology is unknown. The system also supports laboratory confirmation of seroconversion following HBV infection.
The Elecsys Anti-HBS Test System is intended for use in clinical microbiology laboratories under FDA_PMA authorization (PMA P010054). It is supplied as a reagent kit for the Roche Elecsys 2010 analyzer and is not intended for direct patient use. The system includes the Elecsys Anti-HBS immunoassay and the Elecsys Precicontrol Anti-HBS for quality control purposes, with performance validated exclusively on the specified analyzer. Storage and handling comply with standard immunoassay protocols, and regulatory compliance is governed under FDA Premarket Approval (PMA) regulations (866.3173).
Other devices from Roche Diagnostics Corp.
Questions
AI-generated answers, 18 Sep 2026
What clinical questions can the Elecsys Anti-HBS Test System help answer in patient care?
The Elecsys Anti-HBS Test System detects total antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA), enabling laboratories to assess an individual’s susceptibility to hepatitis B virus (HBV) infection—especially before or after vaccination. It also aids in confirming seroconversion post-infection and supports differential diagnosis of hepatitis when the cause is unclear, helping clinicians correlate results with other HBV serological markers for a comprehensive diagnosis.
Is this test compatible with any analyzer besides the Roche Elecsys 2010?
No, the Elecsys Anti-HBS Test System is exclusively validated for use on the Roche Elecsys 2010 immunoassay analyzer. The manufacturer has not established performance with any other systems, so compatibility is limited to this specific platform.
How is the Elecsys Anti-HBS Test System supplied, and what does the kit include?
The system is supplied as a reagent kit designed for the Roche Elecsys 2010 analyzer. It includes the Elecsys Anti-HBS immunoassay (for qualitative/quantitative detection of anti-HBs antibodies) and the Elecsys Precicontrol Anti-HBS, which serves as a quality control tool. The kit is not intended for direct patient use but is meant for laboratory testing only.
What sample types can be tested with this system, and are there any restrictions?
The Elecsys Anti-HBS Test System is designed to analyze human serum and EDTA-plasma only. No other sample types (e.g., whole blood, urine, or non-EDTA plasma) are specified for use, and adherence to these restrictions is critical for accurate results.
What regulatory pathway was followed for this device’s approval, and how does that affect its use?
The Elecsys Anti-HBS Test System received FDA Premarket Approval (PMA) under PMA number P010054, indicating a rigorous review process for high-risk medical devices. This approval confirms its compliance with FDA regulations (866.3173) and restricts its use to clinical microbiology laboratories under the specified PMA authorization. The system is not intended for point-of-care or home testing.