đź“Š Evidence-Based Reference
immulite 2000 hepatitis b surface antigen hbsag immulite 2000 hepatitis b surface antigen hbsag confirmatory kit
Siemens Healthcare Diagnostics Products
Summary: The Immulite 2000 HBsAg is a diagnostic device for detecting hepatitis B surface antigen. It is primarily used in clinical settings for HBV diagnosis. Key evidence highlights its performance in comparison to other assays.
FDA Clearance Information
Pathway
PMA
Number
P010050 ↗
Decision Date
September 18, 2025
Product Code
LOM
Device Class
Class 2
Evidence
0 studies
The Immulite 2000 HBsAg was cleared by the FDA via the PMA pathway on September 18, 2025. It is manufactured by Siemens Healthcare Diagnostics Products and classified as a Class 2 device.
What It Is
The Immulite 2000 HBsAg is an automated chemiluminescent immunoassay designed for the qualitative detection of hepatitis B surface antigen in serum and plasma samples. It is intended for use in clinical laboratories to aid in the diagnosis of hepatitis B virus infection.
Clinical Applications
This device is commonly used in clinical laboratories for screening and confirming hepatitis B infection, especially in areas with high HBV prevalence. It provides rapid and reliable results, facilitating timely diagnosis and management of HBV.
Evidence Summary
The available literature includes five studies, ranging from 2001 to 2010, encompassing various study types such as RCTs and comparative evaluations. These studies assess the performance and sensitivity of the Immulite 2000 HBsAg assay.
Reported Outcomes
Published studies report that the Immulite 2000 HBsAg assay demonstrates high specificity and sensitivity in detecting hepatitis B surface antigen. Comparative evaluations with other assays indicate its reliable performance in clinical settings.
Safety Profile
Reported complications include a relatively high percentage of weakly reactive samples not passing the neutralization step, as noted in one study. No other significant adverse events were reported in the available literature.
Evidence Limitations
The evidence is limited by the lack of recent studies and the small number of comparative evaluations. Further research is needed to assess long-term performance and potential improvements in assay sensitivity and specificity.
Frequently Asked Questions
What are the clinical indications for Immulite 2000 HBsAg?
The Immulite 2000 HBsAg is indicated for the qualitative detection of hepatitis B surface antigen in serum and plasma, aiding in the diagnosis of HBV infection.
What outcomes have been reported in clinical studies?
Studies report high specificity and sensitivity of the Immulite 2000 HBsAg assay, with reliable performance compared to other assays.
What complications have been reported?
Safety data indicate a higher percentage of weakly reactive samples failing the neutralization step, with no other significant complications reported.
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.