Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
FDA premarket approval P160019/S010 · decided 2020-02-27
Approval details
- PMA number
- P160019
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Roche Diagnostics, Inc.
- Date received
- 2019-09-03
- Decision date
- 2020-02-27
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- Approval for (1) the inclusion of a biotin scavenger antibody in Reagent 2 of the test kit to increase the biotin tolerance of the assay and (2) the proposed labeling changes for Elecsys HBsAg II and Elecsys HBsAg Confirmatory Test.
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