VIDAS Lyme IgG

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K122986 ↗

FDA Product Code

LSR

Device Class

Class II

Regulation

21 CFR Part 866.3830

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomerieux S.A. →

• What is the VIDAS Lyme IgG reagent used for in clinical settings?

  The VIDAS Lyme IgG is a reagent designed for the detection of antibodies to Borrelia burgdorferi, the bacterium responsible for Lyme disease. It is used as part of serological testing to identify immune response markers in patient samples, aiding clinicians in the diagnostic evaluation of potential Lyme infection. The test is intended for use on VIDAS family instruments, which are automated immunoassay systems.

• Is the VIDAS Lyme IgG supplied as a single-use or reusable test kit?

  The device data does not specify whether the VIDAS Lyme IgG is supplied as single-use or reusable. However, given that it is a reagent intended for use on automated VIDAS instruments and classified as a serological reagent, it is typically provided in kit formats designed for single testing or batch runs. Users should consult the manufacturer’s package insert or product documentation for detailed information on kit configuration, reusability, and intended number of tests per unit.

• What instrument compatibility is required for using VIDAS Lyme IgG?

  The VIDAS Lyme IgG is intended for use on VIDAS family instruments. These are automated immunoassay systems developed by bioMérieux for clinical laboratory use. The reagent is formulated and validated specifically for these platforms, ensuring proper calibration, sample handling, and result interpretation. Users must ensure their laboratory is equipped with a compatible VIDAS instrument model to perform the test.

• How should the VIDAS Lyme IgG reagent be stored prior to use?

  The device data does not include specific storage conditions such as temperature requirements or shelf life. However, serological reagents of this type are typically stored under controlled conditions, often at 2–8°C, to maintain reagent stability and performance. For accurate storage instructions, including freeze-thaw protocols and expiration dating, laboratories should refer to the manufacturer’s labeling or product insert accompanying the reagent kit.

• What regulatory pathway was followed for the clearance of this device?

  The VIDAS Lyme IgG received FDA 510(k) clearance under product code LSR and regulation number 866.3830. The submission was reviewed under the traditional clearance pathway, with a decision of substantial equivalence to a predicate device. The review was conducted by the Microbiology advisory committee, and the clearance was granted on March 5, 2013, under K-number K122986. This indicates the device met the regulatory criteria for safety and effectiveness through comparison to an existing legally marketed device.