Approval for the elecsys anti-hbs ii, precicontrol anti-hbs, anti-hbs calcheck. Elecsys anti-hbs ii immunoassay for the in vitro quantitative determination of total antibodies to the hepatitis b surface antigen (hbsag) in human adult, pregnant women, and pediatric (ages 2 to 21 years) serum and plasma (k2-edta and k3-edta). Assay results may be used as an aid in the determination of susceptibilty to hepatitis b virus (hbv) infection for individuals prior to or following hbv vaccination; or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptons of hepatitis in whom etiology is unknown. The detection of anti-hbs is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection or from vaccination. The electrochemiluminescence immunoassay eclia is intended for use on the cobas e 601 immunoassay analyzer. Precicontrol anti-hbsprecicontrol anti-hbs is used for quality control of the elecsys anti-hbs immunoassay on the elecsys and cobas e immunoassay analyzers and of the elecsys anti-hbs ii immunoassay on the cobas e 601 immunoassay analyzer. The performance of precicontrol anti-hbs has not been established with any other anti-hbs assay. Anti-hbs calcheckanti-hbs calcheck is an assayed control material for use in the verification of the calibration established by the elecsys anti-hbs immunoassay on the cobas e immunoassay analyzers and by the elecsys anti-hbs ii immunoassay on the cobas e 601 immunoassay analyzer.
| Device | Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | Roche Diagnostics |
| Date Received | 2019-12-30 |
| Decision Date | 2021-02-23 |
| PMA | P190034 |
| Supplement | S |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Diagnostics 9115 Hague Road po Box 50416 indianapolis, IN 46250 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190034 | Original Filing | |
| S001 | 2021-11-29 | 30-day Notice |