Elecsys HBsAg II Auto Confirm
FDA premarket approval P160019/S011 · decided 2020-10-19
Approval details
- PMA number
- P160019
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Elecsys HBsAg II Auto Confirm
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics, Inc.
- Date received
- 2019-11-27
- Decision date
- 2020-10-19
- Days to decision
- 327 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- 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 co
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