← Back to catalogue

Legionella ELISA Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K970149

by Zeus Scientific, Inc.

Identifiers

510(k) Number
K970149 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 Legionella ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of total antibody (IgG, IgM, IgA) to Legionella pneumophila Groups 1–6 in human serum. It functions as an immunoassay to identify immune responses to Legionella bacteria, aiding in the diagnosis of legionellosis. The system employs antibody-based detection to differentiate between different immunoglobulin classes, providing a rapid and sensitive method for serological testing.

This test system is supplied as a manual or automated reagent kit for in vitro diagnostic use in clinical microbiology laboratories. It is intended for single-use per test strip or well, with no sterilisation requirements beyond standard laboratory hygiene. The product is classified under FDA regulation 866.3300 and holds a 510(k) clearance (K970149) for substantial equivalence in microbiology applications. Storage conditions and lot-specific instructions must be followed as per the accompanying documentation.

Frequently asked questions

What is the Legionella ELISA Test System used for?

This test system detects total antibodies (IgG, IgM, IgA) against *Legionella pneumophila* Groups 1–6 in human serum. It helps identify immune responses to Legionella bacteria, supporting the diagnosis of legionellosis—a respiratory infection caused by these bacteria. The immunoassay differentiates immunoglobulin classes, enabling clinicians to assess exposure or infection status.

How is the Legionella ELISA Test System supplied, and is it single-use?

The system is supplied as a manual or automated reagent kit for in vitro diagnostic use. Each test strip or well is designed for single-use only, eliminating the need for sterilization beyond standard laboratory hygiene practices. This ensures consistency and reduces cross-contamination risk in clinical settings.

Does the test require special storage conditions?

Storage conditions are specified in the accompanying documentation and must be followed strictly. While exact details are not provided here, typical ELISA reagents require protection from extreme temperatures, light, and moisture. Always refer to the lot-specific instructions to maintain test validity and performance.

Is this test approved for clinical use, and under what regulatory framework?

Yes, the Legionella ELISA Test System holds FDA 510(k) clearance (K970149) under substantial equivalence in microbiology applications. It falls under FDA regulation 866.3300 and is classified as a Class II device. The clearance confirms its safety and effectiveness for detecting Legionella antibodies in human serum as intended.

What types of laboratories can use this test system?

This system is intended for use in clinical microbiology laboratories equipped to perform in vitro diagnostic tests. It is designed for manual or automated processing, making it suitable for both small and larger lab settings. The kit’s single-use format and immunoassay technology align with standard serological testing workflows for respiratory infections.

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 ..., LEGIONELLA ELISA TEST SYSTEM (K970149) — FDA 510(k) | Innolitics, THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA 510(k) K970149 24 fields · synced Oct 1, 2026