Architect HBSAG Confirmatory
by Abbott Laboratories PMA
Withdrawn
PMA P060007
Overview
The Architect HBSAG Confirmatory is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma (dipotassium EDTA). This assay is designed to provide presumptive evidence of hepatitis B virus (HBV) infection when used alongside other laboratory results and clinical information, though it does not determine the state of infection or associated disease.
The device is intended for use on the Architect i system and is supplied as part of a reagent kit, including calibrators and controls. It is approved by the FDA under PMA (P060007) and classified as a Class II medical device (product code LOM). The assay requires calibration with the provided calibrators and may be used to screen pregnant females for HBV to identify neonates at risk during the perinatal period. The device is not intended for use with other HBsAg assays.
Regulatory status
Withdrawn since 7 Sep 2006. The authorization below is no longer in force.
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP060007 | Date7 Sep 2006 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Recalls
-
- Ongoing Z-1847-2025
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Specification
- Full name
- Architect Hbsag/Hbsag Confirmatory
- Trade Name
- Architect Hbsag Reagent Kit, Calibrators, Controls, Confirmatory Reagent Kit, Confirmatory Manual Diluent
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- PMA Number
- FDA Product Code
- LOM
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3172
- Advisory Committee
- Microbiology
- FDA Decision
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What is the purpose of the Architect HBSAG Confirmatory assay?
The Architect HBSAG Confirmatory is a chemiluminescent microparticle immunoassay (CMIA) designed for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma. It provides presumptive evidence of hepatitis B virus infection when used with other laboratory results and clinical information.
What sample types can be used with this assay?
The assay is designed to work with human adult and pediatric serum and plasma samples that have been collected with dipotassium EDTA as an anticoagulant. It is not intended for use with other sample types or with other HBsAg assays.
How is the Architect HBSAG Confirmatory supplied?
The device is supplied as part of a reagent kit that includes calibrators and controls. The assay requires calibration with the provided calibrators before use. It is designed specifically for use on the Architect i system.
Can this assay be used to screen pregnant females for hepatitis B?
Yes, the assay may be used to screen pregnant females for HBV infection to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. This helps in implementing appropriate preventive measures for newborns.
What information does the assay provide about the state of infection?
The assay provides presumptive evidence of hepatitis B virus infection when used with other laboratory results and clinical information. However, it does not determine the state of infection or associated disease. Additional testing and clinical evaluation are required for a complete assessment.