Advia Centaur HAV Total Assay, Advia Centaur HAV Total Quality Control Materials
by Bayer Healthcare, Diagnostics Division
PMA P040017
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP040017 | Date7 Mar 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Hepatitis a test (antibody and igm antibody)
- PMA Number
- FDA Product Code
- LOL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3310
- Advisory Committee
- Microbiology
- FDA Decision
- APRL
Overview
AI-generated summary, 20 Sep 2026
The Advia Centaur HAV Total Assay is an in vitro diagnostic immunoassay designed for the qualitative detection of total antibodies to hepatitis A virus (anti-HAV) in human serum or plasma (potassium EDTA, lithium heparin, or sodium heparin). This assay aids in diagnosing past or current hepatitis A viral infections and identifies susceptible individuals for vaccination. The Advia Centaur HAV Total Quality Control Materials are intended exclusively for monitoring the performance of the HAV Total Assay on Advia Centaur systems, ensuring assay accuracy and reliability.
The device operates on the Advia Centaur system, a laboratory platform for automated immunoassays. Supplied as a kit, it includes reagents and controls for single-use testing in clinical microbiology laboratories. The assay requires no special storage conditions beyond standard refrigeration for unopened materials and adheres to FDA-approved standards under PMA authorization (P040017). No MRI safety or reusable components are specified, and the materials are intended for in vitro diagnostic use only.
Other devices from Bayer Healthcare, Diagnostics Division
Questions
AI-generated answers, 20 Sep 2026
What types of patient samples can the Advia Centaur HAV Total Assay test, and why is this important for clinical workflows?
The Advia Centaur HAV Total Assay is designed to detect total antibodies to hepatitis A virus (anti-HAV) in human serum or plasma collected with potassium EDTA, lithium heparin, or sodium heparin. This flexibility is important for clinical workflows because it accommodates the most common sample types used in microbiology labs, reducing the need for additional processing steps and ensuring compatibility with standard specimen handling protocols.
Are the Advia Centaur HAV Total Assay and its quality control materials single-use, and how should they be stored?
Yes, the Advia Centaur HAV Total Assay and its quality control materials are single-use only, supplied as part of a kit for automated testing on the Advia Centaur system. Unopened materials require standard refrigeration—no special conditions are specified—while opened or prepared reagents should follow the manufacturer’s instructions for immediate or short-term use to maintain accuracy.
What is the primary purpose of the Advia Centaur HAV Total Quality Control Materials, and can they be used with other hepatitis A assays?
The Advia Centaur HAV Total Quality Control Materials are exclusively for monitoring the performance of the HAV Total Assay on Advia Centaur systems, ensuring assay accuracy and reliability. They are not validated for use with other hepatitis A assays, as their performance has not been established outside the Advia Centaur platform, per the manufacturer’s specifications.
How does the regulatory authorization for this device impact its use in clinical microbiology labs?
The Advia Centaur HAV Total Assay and its quality control materials are authorized under FDA PMA (Premarket Approval) with PMA number P040017, meaning they meet rigorous standards for safety and effectiveness as an in vitro diagnostic tool. This authorization ensures labs can confidently use the assay for diagnosing past or current hepatitis A infections or identifying susceptible individuals for vaccination, adhering to FDA-approved standards for immunoassay performance.