Advia Centaur HAV IGM Ready Pack Reagents, Advia Centaur HAV IGM Quality Control Materials
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS FDA PMA
- Generic Name
- Hepatitis a test (antibody and igm antibody) FDA PMA
Identifiers
- PMA Number
- P040018 FDA PMA
- FDA Product Code
- LOL FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3310 FDA PMA
- Regulation Number
- 866.3310 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Advia Centaur HAV IGM Ready Pack Reagents and Quality Control Materials are in vitro diagnostic immunoassays designed for the qualitative detection of IgM antibodies to Hepatitis A Virus (HAV) in human serum or plasma (collected with potassium EDTA, lithium heparin, or sodium heparin). This assay is intended for use on the Advia Centaur system to aid in diagnosing acute or recent HAV infection, typically within six months of exposure. The Quality Control Materials are specifically intended for monitoring the performance of the HAV IgM assay on Advia Centaur systems and are not validated for use with other anti-HAV IgM assays.
These reagents and controls are supplied as ready-to-use materials for laboratory testing and are intended for single-use. The device is regulated under FDA Premarket Approval (PMA) and classified as a Class II medical device (regulation number 866.3310). Storage and handling conditions are not specified in the provided data, but compliance with standard in vitro diagnostic assay protocols is required. The product is authorized for use in microbiology settings, as indicated by its advisory committee classification.
Frequently asked questions
What is the primary purpose of the Advia Centaur HAV IgM Ready Pack Reagents and how does it differ from the Quality Control Materials?
The Advia Centaur HAV IgM Ready Pack Reagents are designed for the qualitative detection of IgM antibodies to Hepatitis A Virus (HAV) in human serum or plasma, collected with potassium EDTA, lithium heparin, or sodium heparin. They are intended to aid in diagnosing acute or recent HAV infection—typically within six months of exposure—when used on the Advia Centaur system. In contrast, the HAV IgM Quality Control Materials are specifically meant for monitoring the performance of the HAV IgM assay *only* on Advia Centaur systems and are not validated for use with other anti-HAV IgM assays.
Are these reagents and controls single-use, and if so, what does that mean for laboratory workflow?
Yes, the Advia Centaur HAV IgM Ready Pack Reagents and Quality Control Materials are intended for single-use only. This means each pack is designed for one test run or quality check, ensuring accuracy and preventing cross-contamination. Laboratories must use a fresh pack for each patient sample or control run, which helps maintain reliable results and adheres to standard in vitro diagnostic assay protocols.
What types of patient samples can be tested with these reagents, and are there any restrictions on sample collection?
These reagents are intended for use with human serum or plasma collected using potassium EDTA, lithium heparin, or sodium heparin. The sample must be compatible with the Advia Centaur system for accurate detection of IgM antibodies to Hepatitis A Virus. No other anticoagulants or sample types are specified for use.
How do I know if the Advia Centaur HAV IgM Quality Control Materials are compatible with my lab’s testing system?
The HAV IgM Quality Control Materials are *exclusively* validated for use with Advia Centaur systems. If your lab uses a different testing platform for anti-HAV IgM assays, these controls will not provide accurate performance monitoring. Always verify system compatibility before use to ensure reliable quality control results.
What regulatory pathway was followed for the approval of these reagents, and what class of medical device are they?
The Advia Centaur HAV IgM Ready Pack Reagents and Quality Control Materials were approved through the FDA’s Premarket Approval (PMA) process, which is a rigorous review pathway for higher-risk medical devices. They are classified as a Class II device under regulation number 866.3310, indicating a balance of moderate risk and regulatory oversight for in vitro diagnostic assays.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040018 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA PMA P040018 24 fields · synced Oct 6, 2026