The liaison® xl murex hbsag qual assay is an in vitro chemiluminescent immunoassay for the qualitative detection of hepatitis b surface antigen (hbsag) in human adult and pediatric (2 to 21 years) serum and plasma (lithium and sodium heparin, sodium citrate and potassium edta) including separator tubes, on the liaison® xl analyzer. Assay results in conjunction with other hepatitis b virus (hbv) serological 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 may also be used to screen for hbv infection in pregnant women to identify neonates who are at risk for acquiring hepatitis b during the perinatal period. The liaison® xl murex control hbsag qual (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the liaison® xl murex hbsag qual assay. The performance characteristics of liaison® controls have not been established for any other assays or instrument platforms different from liaison® xl. For details, refer to the analyzer operator's manual. The liaison® xl murex hbsag confirmatory is an in vitro neutralization assay for confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum and plasma samples found repeatedly reactive for hbsag by the liaison® xl murex hbsag qual ([ref] 318250).
| Device | LIAISON XL MUREX HBsAg Qual, LIAISON MUREX Control HBsAg, and LIAISON XL MUREX HBsAg Confirmatory Test |
| Generic Name | Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm) |
| Applicant | DiaSorin Inc |
| Date Received | 2019-06-28 |
| Decision Date | 2020-08-29 |
| PMA | P190017 |
| 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 |
|---|---|---|
| P190017 | Original Filing | |
| S010 | 2022-11-10 | 30-day Notice |
| S009 | ||
| S008 | 2022-09-21 | Real-time Process |
| S007 | ||
| S006 | 2022-04-05 | Real-time Process |
| S005 | 2022-04-05 | 30-day Notice |
| S004 | 2022-02-04 | Real-time Process |
| S003 | 2021-11-19 | Real-time Process |
| S002 | 2021-05-27 | Real-time Process |
| S001 |