- Device
- Elecsys HBsAg II Auto Confirm
- Applicant
- Roche Diagnostics, Inc.
- PMA number
- P160019
- Supplement
- S011
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2020-10-19
- Decision code
- APPR
- Date received
- 2019-11-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for 1) the Elecsys HBsAg II Auto Confirm: Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, lithium heparin, K2-EDTA, sodium citrate) samples repeatedly reactive when tested with the Elecsys HBsAg II assay. The electrochemiluminescence immunoassay ECLIA is intended for use on cobas e immunoassay analyzers;2) the PreciControl HBsAg Auto Confirm: PreciControl HBsAg Auto Confirm is used for quality control of the Elecsys HBsAg II Auto Confirm Immunoassay on the cobas e 801 immunoassay analyzer; and 3) the PreciControl HBsAg II: PreciControl HBsAg II is used for quality control of the Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm immunoassays on the cobas e immunoassay analyzers. The performance of PreciControl HBsAg II has not been established with any other HBsAg assay.