Borrelia Burgdorferi IgM ELISA Test System
by Trinity Biotech USA 510(k)
Active
510(k) K033070
Overview
The Borrelia Burgdorferi IgM ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) reagent designed for the qualitative presumptive detection of IgM antibodies against Borrelia burgdorferi, the causative agent of Lyme disease. This in vitro diagnostic device aids in identifying early-stage infection by measuring immune responses in patient serum or plasma samples, supporting microbiological testing in clinical settings.
This system is supplied as a reagent kit for laboratory use, intended for single-use per test. It is not sterile and requires preparation in a controlled environment per manufacturer instructions. The device is classified under FDA regulation 866.3830 as a Class II medical device (Product Code: LSR) and holds a 510(k) clearance for substantial equivalence. Storage and handling must comply with standard microbiological assay protocols to ensure accuracy and reliability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033070 | 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- Withdrawn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
- LSR
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3830
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
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Questions
What is the primary purpose of the Borrelia Burgdorferi IgM ELISA Test System in clinical settings?
This test system is designed for the qualitative presumptive detection of IgM antibodies against *Borrelia burgdorferi*, the bacteria responsible for Lyme disease. It helps identify early-stage infections by measuring immune responses in patient serum or plasma samples, supporting microbiological testing in laboratory environments.
Is this test system intended for single-use or repeated use, and why?
The Borrelia Burgdorferi IgM ELISA Test System is explicitly supplied as a reagent kit for single-use per test. The manufacturer’s instructions specify preparation in a controlled environment, and the lack of sterility labeling confirms it is not intended for reuse, as repeated use could compromise accuracy and introduce contamination risks.
How should this test system be stored, and what precautions should be taken?
While the data does not specify exact storage conditions, as a microbiological assay reagent, it must be handled per standard microbiological protocols to maintain accuracy. Storage should follow the manufacturer’s guidelines (not provided here) to prevent degradation, and it should be kept in a controlled environment to avoid contamination or exposure to extreme temperatures.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The device received 510(k) clearance under the traditional review pathway, determined to be *substantially equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class II medical device (Product Code: LSR) and is authorized for laboratory use in detecting *Borrelia burgdorferi* IgM antibodies, though clearance does not imply it is intended for any specific clinical indication.
Does this test system require sterile handling, and if not, what does that imply for its use?
The Borrelia Burgdorferi IgM ELISA Test System is not sterile, as explicitly stated in the data. This means it must be prepared in a controlled, non-sterile environment (e.g., a laboratory setting) following manufacturer instructions to avoid contamination. Sterility is not required for this type of reagent-based assay, but proper aseptic technique during sample preparation is critical to ensure reliable results.