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Atellica Im Anti-Hepatitis B Surface Antigen 2 AHBS2 Assay
Siemens Healthcare Diagnostics
Summary: The Atellica IM Anti-Hepatitis B Surface Antigen 2 Assay is a diagnostic tool used to detect hepatitis B surface antigens in patients. It is primarily used by laboratory professionals in clinical settings.
FDA Clearance Information
Pathway ?
PMA
Number ?
P100039 ↗
Decision Date ?
April 27, 2021
Product Code ?
LOM
Device Class ?
Class 2
Evidence ?
0 studies
The Atellica IM Anti-Hepatitis B Surface Antigen 2 Assay, manufactured by Siemens Healthcare Diagnostics, was cleared by the FDA on April 27, 2021, under PMA P100039. It is classified as a Class 2 device.
What It Is
The Atellica IM Anti-Hepatitis B Surface Antigen 2 Assay is a diagnostic assay designed to detect the presence of hepatitis B surface antigens in blood samples. It operates on the Atellica IM Analyzer platform, which automates the testing process to provide rapid and accurate results. This assay is crucial for diagnosing and monitoring hepatitis B infections, aiding in the management of the disease.
FDA-Cleared Indications
- Detection of hepatitis B surface antigen in human blood samples using the Atellica IM Analyzer.
- Use as an in vitro diagnostic assay in clinical laboratory testing for hepatitis B surface antigen.
Clinical Applications
- Laboratory testing of blood samples for hepatitis B surface antigen.
- Hepatitis B screening performed according to the assay’s laboratory labeling and institutional protocols.
- Testing ordered when hepatitis B infection is being evaluated.
Practical Considerations
- This is a laboratory assay, not an implantable or therapeutic device, and it is not used during an interventional procedure.
- The assay is intended for use with the Siemens Atellica IM Analyzer platform and compatible laboratory supplies.
- Specimen collection, handling, storage, calibration, quality control and result interpretation should follow the current manufacturer’s instructions.
- Results should be interpreted with clinical findings and other hepatitis B tests; a reactive or nonreactive result alone does not establish the complete clinical status of infection.
- The assay has no MRI-safety classification because it is an in vitro diagnostic test rather than a device placed in or on the patient.
Frequently Asked Questions
What is the Atellica IM Anti-Hepatitis B Surface Antigen 2 Assay used for?
It is used to detect hepatitis B surface antigens in blood samples, aiding in the diagnosis and monitoring of hepatitis B infections.
What specialties typically use this device?
This assay is typically used by laboratory professionals in clinical pathology and infectious disease specialties.
What are the FDA-cleared indications?
The assay is cleared for detecting hepatitis B surface antigens in patients, which helps identify active hepatitis B infections.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.