Borrelia Burgdorferi IgG/IgM ELISA Test System
by Trinity Biotech USA 510(k)
Active
510(k) K033083
Overview
This device is a Reagent, Borrelia Serological Reagent designed for the qualitative presumptive detection of total IgG/IgM antibodies to Borrelia burgdorferi in human serum. It employs an Enzyme-Linked Immunosorbent Assay (ELISA) to identify antibody presence as an initial screening tool for Lyme disease.
The system is supplied as a kit for laboratory use, with configurations available for 96 or 480 tests. It is intended for single-use and requires no sterilization beyond manufacturer-provided packaging. Regulated under FDA 510(k) clearance (K033083), it adheres to microbiological standards for serological testing and is classified as a Class II device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033083 | Date26 Nov 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LSR
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3830
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Trinity Biotech USA
Questions
What is the primary purpose of the Borrelia burgdorferi IgG/IgM ELISA Test System, and how does it function in diagnosing Lyme disease?
The Borrelia burgdorferi IgG/IgM ELISA Test System is designed as an initial screening tool for Lyme disease by qualitatively detecting total IgG and IgM antibodies to *Borrelia burgdorferi* in human serum. It uses an enzyme-linked immunosorbent assay (ELISA) to identify antibody presence, helping clinicians identify potential exposure to the bacteria responsible for Lyme disease. This test serves as a presumptive screening method, not a definitive diagnosis.
How is the Borrelia burgdorferi IgG/IgM ELISA Test System supplied, and what are the available configurations?
The test system is supplied as a laboratory kit, available in two configurations: one for 96 tests and another for 480 tests. This allows laboratories to choose the volume that best fits their testing needs, ensuring flexibility for both small and large-scale diagnostic workflows.
Is the Borrelia burgdorferi IgG/IgM ELISA Test System intended for single-use or reusable applications?
The test system is explicitly designed for single-use only. No additional sterilization beyond the manufacturer-provided packaging is required, as each component is intended to be used once and then discarded.
What regulatory pathway was followed for the FDA clearance of this device, and what class does it belong to?
The Borrelia burgdorferi IgG/IgM ELISA Test System was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process, and is classified as a Class II medical device. This classification reflects its role as a moderate-risk device requiring special controls to ensure safety and effectiveness.
How should the Borrelia burgdorferi IgG/IgM ELISA Test System be stored, and are there any special handling requirements?
While the provided data does not specify storage conditions, as a laboratory reagent, it is generally recommended to follow the manufacturer’s instructions for storage (e.g., refrigeration or room temperature) to maintain stability and accuracy. The system is packaged to ensure sterility and usability, so proper handling—such as avoiding contamination or exposure to extreme temperatures—is critical to preserving test integrity.