Approval for the liaison xl murex anti-hbc assay is an in vitro chemiluminescent immunoassay (clia) for the qualitative detection of igg and igm (total) antibodies to hepatitis b core antigen (anti-hbc) in human adult and pediatric serum and plasma (lithium and sodium heparin, sodium citrate and k2 edta) including separator tubes, on the liaison xl analyzer. Assay results in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis b virus (hbv) infection in patients with symptoms of hepatitis or who may be at risk for hbv infection. The assay is not intended for use in screening blood, plasma or tissue donors. The liaison xl murex control anti-hbc (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the liaison xl murex anti-hbc assay. The performance characteristics of liaison xl murex control anti-hbc have not been established for any other assays or instrument platforms.
| Device | LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc. |
| Date Received | 2018-09-26 |
| Decision Date | 2020-01-02 |
| PMA | P180038 |
| 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 |
|---|---|---|
| P180038 | Original Filing | |
| S014 | 2022-11-10 | 30-day Notice |
| S013 | ||
| S012 | 2022-04-05 | Real-time Process |
| S011 | 2022-04-05 | 30-day Notice |
| S010 | 2022-02-04 | Real-time Process |
| S009 | 2021-11-23 | 30-day Notice |
| S008 | 2021-11-23 | 30-day Notice |
| S007 | 2021-11-23 | 30-day Notice |
| S006 | ||
| S005 | 2021-05-27 | Real-time Process |
| S004 | ||
| S003 | 2020-07-16 | 30-day Notice |
| S002 | 2020-06-18 | Real-time Process |
| S001 | 2020-02-13 | Real-time Process |