The liaison® xl murex hbc igm assay is an in vitro chemiluminescent immunoassay (clia) for the qualitative detection of igm antibodies to hepatitis b virus core antigen (hbc igm) in human adult and pediatric (2 to 21 years) 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 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 presence of anti-hbc igm is indicative of acute or recent hbv infection. This assay is not approved for use in screening blood, plasma or tissue donors. The liaison® xl murex control hbc igm (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the liaison® xl murex hbc igm assay. The performance characteristics of liaison® xl murex control hbc igm have not been established for any other assays or instrument platforms.
| Device | LIAISON XL MUREX HBc IgM, LIAISON MUREX Control HBc IgM |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc. |
| Date Received | 2018-12-06 |
| Decision Date | 2020-08-29 |
| PMA | P180045 |
| 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 |
|---|---|---|
| P180045 | Original Filing | |
| S011 | 2022-11-10 | 30-day Notice |
| S010 | ||
| S009 | 2022-04-05 | Real-time Process |
| S008 | 2022-04-05 | 30-day Notice |
| S007 | 2022-02-04 | Real-time Process |
| S006 | 2021-11-23 | 30-day Notice |
| S005 | 2021-11-23 | 30-day Notice |
| S004 | 2021-11-23 | 30-day Notice |
| S003 | ||
| S002 | 2021-05-27 | Real-time Process |
| S001 |