Athena Multi-Lyte MPO/PR3 Igg Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040111 FDA 510(k)
- FDA Product Code
- MOB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Athena Multi-Lyte MPO/PR3 Igg Test System is a multiplex, fluorescent, bead-based test system designed for the qualitative and semi-quantitative detection of IgG autoantibodies to human myeloperoxidase (MPO) and proteinase 3 (PR3). It is intended for use in the evaluation of autoimmune diseases, particularly those associated with antineutrophil cytoplasmic antibodies (ANCA).
The system is supplied as a single-use test kit and requires the AtheNA Multi-Lyte Instrument, which operates on the Luminex 100/200 System using xMAP Technology. It is not sterilized and should be stored at room temperature. The device is regulated under FDA 510(k) clearance (K040111) and is classified as a Class II medical device in the Immunology specialty.
Frequently asked questions
What is the Athena Multi-Lyte MPO/PR3 IgG Test System used for?
It is a multiplex, fluorescent, bead-based test system designed for the qualitative and semi-quantitative detection of IgG autoantibodies to human myeloperoxidase (MPO) and proteinase 3 (PR3). It is intended for use in the evaluation of autoimmune diseases, particularly those associated with antineutrophil cytoplasmic antibodies (ANCA).
How is the test system supplied and what equipment is required?
The system is supplied as a single-use test kit and requires the AtheNA Multi-Lyte Instrument, which operates on the Luminex 100/200 System using xMAP Technology.
What are the storage and sterility requirements for the device?
The device is not sterilized and should be stored at room temperature.
What is the regulatory status of this device?
The device is regulated under FDA 510(k) clearance (K040111) and is classified as a Class II medical device in the Immunology specialty.
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. Sources consulted: AtheNA Multi-Lyte<sup>®</sup> Test Systems - ZEUS Scientific, Zeus Scientific, Inc., Athena Multi-lyte Mpo/Pr3 Igg Test System ..., AtheNA Multi-Lyte<sup>®</sup> Instrument - ZEUS Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040111 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K040111 24 fields · synced Sep 26, 2026