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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.
Clinical Applications
This assay is commonly used in clinical laboratories for the screening and diagnosis of hepatitis B infection. It is particularly important in settings such as hospitals and public health laboratories where timely and accurate diagnosis is critical. The assay is used for patients suspected of having hepatitis B, those undergoing routine health screenings, and individuals at risk of infection.
Indications for Use
The FDA indications for this assay involve the detection of hepatitis B surface antigens, which are markers of active infection. It is intended for use in patients who need to be screened for hepatitis B, including those with symptoms or at high risk of infection.
Practical Considerations
The Atellica IM Anti-Hepatitis B Surface Antigen 2 Assay is compatible with the Atellica IM Analyzer, which is known for its efficiency and accuracy. Clinicians should ensure proper sample handling and follow the manufacturer's guidelines for optimal results.
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.