Architect Core Reagent Kit, Calibrator and Controls
by Abbott Laboratories PMA
Active
PMA P080023
Overview
The Architect Core Reagent Kit, Calibrator and Controls are in vitro diagnostic devices designed for the qualitative detection of IgG and IgM antibodies to Hepatitis B core antigen (Anti-HBC) in human serum, plasma (including dipotassium EDTA, lithium heparin, sodium heparin), and neonatal serum. This chemiluminescent microparticle immunoassay (CMIA) aids in diagnosing acute, chronic, or resolved Hepatitis B virus (HBV) infection when used alongside other laboratory results and clinical information.
The kit is intended for use with the Architect iSystem platform and includes a reagent kit for assay performance, a calibrator for system calibration, and controls for monitoring analytical performance. Supplied as single-use components, these devices are regulated under FDA PMA (P080023) and fall under Class II medical devices (SEI product code). They are not intended for use with other Anti-HBC assays and must be stored and handled according to manufacturer instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP080023 | Date10 Apr 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Architect Core Reagent Kit, Architect Core Calibrator and Architect Core Controls
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- PMA Number
- FDA Product Code
- SEI
- Regulation
- 21 CFR Part 866.3173
- Advisory Committee
- Microbiology
- FDA Decision
- APRL
Other devices from Abbott Laboratories
Questions
What types of samples can the Architect Core Reagent Kit test for Hepatitis B core antibodies, and why is this important for clinical use?
The Architect Core Reagent Kit is designed to test for IgG and IgM antibodies to Hepatitis B core antigen (Anti-HBC) in human serum, plasma (including dipotassium EDTA, lithium heparin, sodium heparin), and neonatal serum. This broad sample compatibility is important because it allows for flexible testing across different patient populations, including adults, pediatric patients, and newborns, ensuring comprehensive diagnostic coverage for acute, chronic, or resolved HBV infection.
Is the Architect Core Reagent Kit intended for standalone diagnosis of Hepatitis B virus infection, or does it require additional clinical information?
The kit is not intended for standalone diagnosis—it is an aid in diagnosing acute, chronic, or resolved Hepatitis B virus (HBV) infection. The manufacturer explicitly states it must be used alongside other laboratory results and clinical information for accurate interpretation, emphasizing its role as a supplementary diagnostic tool rather than a definitive test.
How are the Architect Core Reagent Kit, Calibrator, and Controls supplied, and what does this mean for laboratory workflow?
The kit, calibrator, and controls are supplied as single-use components, meaning each reagent kit, calibrator vial, and control set is designed for one-time use only. This ensures consistency in assay performance and reduces the risk of cross-contamination, which is critical for reliable diagnostic results in high-volume laboratory workflows.
Can the Architect Core Calibrator or Controls be used with other Anti-HBC assays besides the Architect Core Reagent Kit?
No, the Architect Core Calibrator and Controls are specifically validated only for use with the Architect Core Reagent Kit on the Architect iSystem platform. The manufacturer has not established their performance with any other Anti-HBC assays, so mixing or substituting them with non-Architect components could compromise accuracy and invalidate results.
What regulatory pathway was followed for the approval of this device, and what does the Class II designation imply for its use?
The device was approved via the FDA Premarket Approval (PMA) pathway (PMA #P080023), which is typically reserved for higher-risk medical devices. The Class II designation (SEI product code) indicates it is regulated under special controls to ensure its safety and effectiveness, though it does not imply routine use without clinical correlation—reaffirming the need for integration with additional diagnostic data as outlined in the labeling.