Legionella Pneumophila Igg/Igm
by Trinity Biotech USA 510(k)
Active
510(k) K033051
Overview
This device is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of total antibodies (IgG and IgM) to Legionella pneumophila serogroups 1–6, classified under Microbiology diagnostic reagents. It is designed to aid in the serological identification of Legionella infection in patient serum samples, supporting diagnostic workflows for suspected Legionnaires’ disease.
The Legionella Pneumophila IgG/IgM ELISA is supplied as a single-use in vitro diagnostic test and is regulated under 21 CFR Part 866.3300 as a Class II device. It requires no special storage conditions beyond refrigeration (2–8°C) and is intended for use in clinical microbiology laboratories. Authorized for commercial distribution in the U.S. via FDA 510(k) clearance (K033051), it adheres to standard sterility and performance validation protocols for serological assays.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033051 | Date26 Nov 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MJH
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3300
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Trinity Biotech USA
Questions
What clinical purpose does the Legionella Pneumophila IgG/IgM ELISA serve in diagnosing infections?
This ELISA test detects total antibodies (IgG and IgM) against *Legionella pneumophila* serogroups 1–6 in patient serum samples. It aids in the serological identification of *Legionella* infection, helping clinicians confirm suspected cases of Legionnaires’ disease by identifying immune responses to the bacteria.
Is this test single-use or reusable, and how should it be stored?
The Legionella Pneumophila IgG/IgM ELISA is designed for single-use only per kit. Storage is simple: refrigerate between 2–8°C—no additional conditions are required. Always check the label for expiration dates before use.
Where is this device authorized for use, and what regulatory pathway was followed?
The test is authorized for commercial distribution in the U.S. via an FDA 510(k) clearance (K033051), classified as a Class II device under 21 CFR Part 866.3300. It was deemed *substantially equivalent* to a predicate device through a traditional review process by the FDA’s Microbiology (MI) Advisory Committee.
What type of laboratory setting is this test intended for, and are there any special handling requirements?
This ELISA is intended for use in clinical microbiology laboratories with standard diagnostic workflows. It requires no specialized infrastructure beyond typical lab equipment for serological assays. Since it’s single-use, ensure proper disposal of used components per biohazard protocols.