The liaison xl murex anti-hbs is an in vitro chemiluminescent immunoassay (clia) for the qualitative and quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in human adult and pediatric (2 – 21 years) serum and plasma (lithium and sodium heparin and k2 edta) including separator tubes, on the liaison xl analyzer. Assay results in conjunction with other hepatitis b virus (hbv) serological markers and clinical information may be used as an aid in the diagnosis of hbv infection in patients with symptoms of hepatitis or who may be at risk for hbv infection. The assay results may be used as an aid in the determination of susceptibility to hbv infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. The assay is not approved for use in screening blood, plasma or tissue donors. The liaison xl murex control anti-hbs (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the liaison xl murex anti-hbs assay. The performance characteristics of liaison xl murex control anti-hbs have not been established for any other assays or instrument platforms. The liaison xl murex anti-hbs verifiers (level 1, 2, 3, and level 4) are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the liaison xl murex anti-hbs assay. The performance characteristics of liaison xl murex anti-hbs verifiers have not been established in connection with any other assay or instrument platforms.
| Device | LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc. |
| Date Received | 2018-09-26 |
| Decision Date | 2020-02-21 |
| PMA | P180039 |
| Supplement | S |
| Product Code | LOM |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DiaSorin Inc. 1951 Northwestern Avenue stillwater, MN 55082 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180039 | Original Filing | |
| S013 | 2022-11-10 | 30-day Notice |
| S012 | ||
| S011 | 2022-04-05 | Real-time Process |
| S010 | 2022-04-05 | 30-day Notice |
| S009 | 2022-02-04 | Real-time Process |
| S008 | 2021-11-23 | 30-day Notice |
| S007 | 2021-11-23 | 30-day Notice |
| S006 | 2021-11-23 | 30-day Notice |
| S005 | ||
| S004 | 2021-05-27 | Real-time Process |
| S003 | ||
| S002 | 2020-07-16 | 30-day Notice |
| S001 | 2020-06-18 | Real-time Process |