Aptus Automated Legionella IgG/A/M ELISA Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K984123 FDA 510(k)
- FDA Product Code
- LHL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3300 FDA 510(k)
- Regulation Number
- 866.3300 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aptus Automated Legionella IgG/A/M ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of total antibodies (IgG, IgM, IgA) to Legionella pneumophila serogroups 1–6 in human serum. It functions as a diagnostic reagent system for identifying immune responses to Legionella infections, aiding in the laboratory confirmation of legionellosis. The device leverages automated application of reagents to streamline testing workflows while maintaining specificity for serological markers. Classification aligns with antibody-based immunoassays for direct and indirect fluorescent detection of microbial pathogens, as defined by regulatory nomenclature.
This system is intended for use in clinical microbiology laboratories, where it is supplied as a kit comprising reagents, controls, and disposable components. The test is performed manually or via automated instrumentation, requiring no special handling beyond standard laboratory practices. Sterility is maintained through individual packaging of consumables, and the system is classified as a Class II device under FDA regulations, with clearance granted under 510(k) number K984123. Storage conditions and shelf life are specified in accompanying documentation, adhering to manufacturer guidelines for reagent stability.
Frequently asked questions
What is the Aptus Automated Legionella IgG/A/M ELISA Test System used for?
This system is designed for the qualitative detection of total antibodies (IgG, IgM, IgA) to *Legionella pneumophila* serogroups 1–6 in human serum. It aids in confirming legionellosis by identifying immune responses to Legionella infections, helping clinicians diagnose suspected cases in clinical microbiology laboratories.
How is the Aptus Legionella ELISA Test System supplied, and is it sterile?
The system is supplied as a kit containing reagents, controls, and disposable components. Sterility is maintained through individual packaging of consumables, ensuring safe handling in standard laboratory settings without additional sterilization steps.
Can the Aptus Legionella ELISA Test System be used with automated instrumentation?
Yes, the system leverages automated application of reagents, allowing for integration with automated instrumentation to streamline workflows. While the core test process can also be performed manually, automation enhances efficiency while preserving specificity for serological markers.
Is the Aptus Legionella ELISA Test System single-use or reusable?
The disposable components of the system, such as consumables, are intended for single-use to maintain sterility and accuracy. Reusable parts, if any, are limited to non-consumable instrumentation or components explicitly designed for repeated use under manufacturer guidelines.
What regulatory clearance does the Aptus Legionella ELISA Test System hold?
The device holds FDA clearance under a 510(k) submission (K984123) and is classified as a Class II medical device. It is intended for use in clinical microbiology laboratories and adheres to regulatory standards for antibody-based immunoassays.
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: The Aptus (Automated) Application of The Legionella Igg/A/M (Elisa ..., The Aptus (Automated) Application of The Legionella Igg/A/M (Elisa ..., PDF K984123 the Aptus (Automated) Application of The Legionella Igg/A/M ..., THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984123 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K984123 24 fields · synced Oct 1, 2026