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U.S. Department of Health and Human Services

Product Classification
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Device quantitative hepatitis b surface antigen
Definition A quantitative hepatitis B virus (HBV) surface antigen (HBsAg) test is an in vitro diagnostic device intended for prescription use for the quantitative determination of HBsAg in human serum, plasma, or other matrices specimens from individuals with HBV infection as an aid in the management of HBV-infected individuals including identifying patients who may benefit from treatment with appropriate antiviral therapies in accordance with the approved therapeutic product labeling.
Physical State Fully automated immunochemistry instrument
Technical Method Quantitative immunoassay for antigen
Target Area Blood
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeSJM
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3177
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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