IFA Test for Antibodies to Borrelia Burgdorferi
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K871246 FDA 510(k)
- FDA Product Code
- LSR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3830 FDA 510(k)
- Regulation Number
- 866.3830 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an Indirect Fluorescent Antibody (IFA) Test for Antibodies to Borrelia Burgdorferi, classified as a Reagent for Serological Testing. It is intended for the qualitative and semi-quantitative detection of IgG and IgM antibodies in human serum, aiding in the presumptive diagnosis of Lyme disease.
The IFA Test for Antibodies to Borrelia Burgdorferi is supplied as an in vitro diagnostic (IVD) reagent system and is intended for use in clinical microbiology laboratories. It is a single-use device, requiring no special storage conditions beyond refrigeration as specified in the instructions. The device holds an FDA 510(k) clearance under the classification of Class II Medical Device (Device Class 2) and is regulated under 21 CFR 866.3830.
Frequently asked questions
What is the IFA Test for Antibodies to Borrelia Burgdorferi used for?
This device is an Indirect Fluorescent Antibody (IFA) Test designed for the qualitative and semi-quantitative detection of IgG and IgM antibodies in human serum. It aids in the presumptive diagnosis of Lyme disease by identifying antibodies to *Borrelia burgdorferi*, helping clinicians assess potential infection when used in conjunction with clinical findings.
How is the IFA Test for Borrelia Burgdorferi supplied and stored?
The test is supplied as an in vitro diagnostic (IVD) reagent system, intended for single-use in clinical microbiology laboratories. Storage requires refrigeration as outlined in the instructions for use. No additional specialized storage conditions are specified beyond standard refrigeration.
Is the IFA Test for Borrelia Burgdorferi sterile?
The device is intended for in vitro diagnostic use and is supplied as a reagent system. While the specific sterility claims are not detailed in the provided data, typical IFA tests for serological use are designed to be free from contaminants that could interfere with testing. Always follow the manufacturer’s instructions for handling and preparation to ensure accuracy.
Can this test be reused?
No, the IFA Test for Antibodies to Borrelia Burgdorferi is explicitly designed for single-use only. Reusing the reagent system could compromise test accuracy and introduce cross-contamination risks, potentially leading to false results.
What regulatory pathway does this device follow?
This device holds an FDA 510(k) clearance under the classification of Class II Medical Device (Device Class 2) and is regulated under 21 CFR 866.3830. The clearance was granted as substantially equivalent to a predicate device, following a traditional review process by the FDA’s Microbiology Advisory Committee.
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: B. burgdorferi IgG/IgM Test System - ZEUS Scientific, PDF B. burgdorferi IgG/IgM Test System IVD - zeusscientific.com, AccessGUDID - DEVICE: IFA B. burgdorferi IgG/IgM Test System ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K871246 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K871246 24 fields · synced Oct 1, 2026