ARCHITECT HBsAg Next Qualitative/Next Confirmatory
by Abbott Laboratories PMA
Active
PMA P210003
Overview
The ARCHITECT HBsAg Next Qualitative/Confirmatory is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection and confirmation of hepatitis B surface antigen (HBsAg) in human serum, serum separator tubes, and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, sodium heparin). It is designed for use on the ARCHITECT i System and is intended for adult and pediatric patients aged 2 years to 21 years. The assay provides 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 supplied as a reagent kit, including qualitative and confirmatory assays, calibrators, controls, and a manual diluent for specimen preparation. It is intended for use in microbiology laboratories and is not single-use; components are designed for repeated use within the ARCHITECT i System’s workflow. The system is not MRI-safe, and the device operates under FDA_PMA authorization (PMA Number: P210003). Storage and handling conditions are specified in the accompanying instructions for use, which must be followed to maintain assay validity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP210003 | Date10 Aug 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit
- 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
- APRL
Other devices from Abbott Laboratories
Questions
What types of patient samples can the ARCHITECT HBsAg Next Qualitative/Confirmatory assay test for hepatitis B surface antigen (HBsAg)?
The assay is designed to detect HBsAg in human serum, serum separator tubes, and plasma collected with dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, or sodium heparin. It is intended for use in both adult and pediatric patients aged 2 years to 21 years, making it versatile for a broad range of clinical settings.
How is the ARCHITECT HBsAg Next system supplied, and is it single-use or reusable?
The device is supplied as a reagent kit, including qualitative and confirmatory assays, calibrators, controls, and a manual diluent for specimen preparation. Unlike single-use devices, the components are designed for repeated use within the workflow of the ARCHITECT i System, allowing for efficient testing in microbiology laboratories.
What is the intended clinical use of the ARCHITECT HBsAg Next Qualitative/Confirmatory assay, and how does it support diagnosis?
The assay provides presumptive evidence of hepatitis B virus (HBV) infection when used alongside other laboratory results and clinical information. It is not meant to determine the state of infection or associated disease but can help screen for HBV in patients aged 2–21 years, including pregnant women to identify neonates at risk during perinatal transmission. Confirmatory testing is required for samples repeatedly reactive in the qualitative assay.
What system does the ARCHITECT HBsAg Next Qualitative/Confirmatory assay run on, and are there any special handling requirements?
The assay is exclusively designed for use on the ARCHITECT i System. Storage and handling must strictly follow the instructions for use to maintain assay validity, though specific details like temperature or expiration are not provided in the data. The system is not MRI-safe, so proper placement in clinical environments is important.
What regulatory pathway was followed for the approval of the ARCHITECT HBsAg Next Qualitative/Confirmatory assay?
The device was approved through the FDA’s Premarket Approval (PMA) process, as indicated by the PMA Number (P210003). This pathway is typically used for higher-risk medical devices, ensuring rigorous evaluation of safety and effectiveness before market authorization.