đź“‹ FDA Reference
immulite anti-hepatitis b surface antigen anti-hbs systems
Siemens Healthcare Diagnostics Products
Summary: The Immulite Anti-Hepatitis B Surface Antigen Anti-HBs Systems by Siemens Healthcare is a diagnostic device used to detect antibodies against the hepatitis B surface antigen. It is primarily used by laboratory professionals in clinical settings.
FDA Clearance Information
Pathway
PMA
Number
P010052 ↗
Decision Date
July 27, 2015
Product Code
LOM
Device Class
Class 2
Evidence
0 studies
The Immulite Anti-HBs Systems received FDA clearance through the PMA pathway on July 27, 2015. Manufactured by Siemens Healthcare Diagnostics Products, it is classified as a Class 2 device.
What It Is
The Immulite Anti-Hepatitis B Surface Antigen Anti-HBs Systems is a laboratory diagnostic device designed to detect antibodies against the hepatitis B surface antigen in human serum or plasma. This detection is crucial for determining immunity status in individuals, either post-vaccination or following exposure to the hepatitis B virus. The system utilizes chemiluminescent technology to provide accurate and reliable results.
Clinical Applications
This device is commonly used in clinical laboratories to assess the immune status of patients regarding hepatitis B. It is particularly relevant in infectious disease clinics, immunology departments, and public health settings. The system is used for screening healthcare workers, evaluating vaccine efficacy, and monitoring patients with chronic liver conditions.
Indications for Use
The FDA indication for this device involves a change in the manufacturing process for the conjugate bulk solution, ensuring consistent and reliable performance. It is intended for use in detecting hepatitis B surface antibodies, aiding in the assessment of immunity.
Practical Considerations
The Immulite system is compatible with various serum and plasma samples. It requires standard laboratory equipment for operation and is designed for ease of use in high-throughput settings. Clinicians should ensure proper calibration and maintenance for optimal performance.
Frequently Asked Questions
What is the Immulite Anti-Hepatitis B Surface Antigen Anti-HBs Systems used for?
It is used to detect antibodies against the hepatitis B surface antigen, indicating immunity status in individuals.
What specialties typically use this device?
Laboratory professionals in infectious disease clinics, immunology departments, and public health settings commonly use this device.
What are the FDA-cleared indications?
The device is cleared for detecting hepatitis B surface antibodies, with a focus on a manufacturing process change for the conjugate bulk solution.
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.