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BioPlex 2200 Lyme Total

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183446

by Bio-Rad Laboratories

Identifiers

510(k) Number
K183446 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)

The BioPlex 2200 Lyme Total Assay is a Reagent, Borrelia Serological Reagent designed for the detection of antibodies to Borrelia burgdorferi. This multiplexed immunoassay measures total IgG and IgM antibodies, enabling simultaneous screening for Lyme disease across multiple infection stages. It is classified under Medical Specialty: Microbiology and adheres to regulatory standards outlined in 21 CFR 866.3830.

This assay is intended for use in clinical laboratories equipped with the BioPlex 2200 System, a fully automated, random-access platform. Supplied as a reagent kit, it requires no sterilization beyond standard laboratory aseptic techniques and is intended for single-use per test run. The device is not MRI-compatible and must be stored according to manufacturer instructions to maintain stability. Authorized under FDA 510K clearance (K183446), it is classified as a Class II device under the FDA’s regulatory framework.

Frequently asked questions

What is the BioPlex 2200 Lyme Total Assay used for?

This assay detects total IgG and IgM antibodies to *Borrelia burgdorferi*, the bacterium responsible for Lyme disease. By measuring both antibody classes simultaneously, it helps clinicians screen for infection across early, late, or persistent stages of Lyme disease in a single test. The multiplexed design improves efficiency in clinical microbiology laboratories equipped with the BioPlex 2200 System.

How is the BioPlex 2200 Lyme Total Assay supplied and prepared for use?

The assay is supplied as a reagent kit, designed for single-use per test run on the BioPlex 2200 System. No additional sterilization is required beyond standard laboratory aseptic techniques, as the kit is intended for in vitro diagnostic use in controlled environments. The system automates sample processing, reducing manual handling and potential contamination risks.

Is the BioPlex 2200 Lyme Total Assay reusable or single-use?

The assay itself is intended for single-use per test run, as specified in the kit instructions. However, the BioPlex 2200 System hardware is reusable and designed for high-throughput, random-access testing. This approach ensures cost efficiency for laboratories while maintaining precision and consistency in diagnostic results.

What storage conditions are required for the BioPlex 2200 Lyme Total Assay?

The reagent kit must be stored according to the manufacturer’s instructions to preserve stability and performance. While specific temperature or humidity requirements are not detailed in the provided data, adherence to standard laboratory protocols for immunoassay reagents—typically refrigerated (2–8°C) and protected from light—is recommended. Always refer to the included documentation for exact storage guidelines.

Does the BioPlex 2200 Lyme Total Assay require any special handling or compatibility considerations?

The assay is not MRI-compatible, meaning it should not be exposed to magnetic resonance imaging environments. It is exclusively compatible with the BioPlex 2200 System, a fully automated platform, and cannot be used with other diagnostic devices. Laboratories must ensure proper system calibration and maintenance to achieve accurate results, as the assay relies on the platform’s integrated immunoassay technology.

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: BioPlex 2200 Lyme Total - Bio-Rad, Bio-Rad | lymetotal, BioPlex 2200 System for Autoimmune Testing — Bio-Rad, A Fully Automated Multiplex Assay for Diagnosis of Lyme Disease with ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA 510(k) K183446 24 fields · synced Oct 1, 2026