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# FDA Clears Quidel’s Sofia 2 Lyme Immunoassay
- URL: https://www.fdaweb.com/fda-clears-quidels-sofia-2-lyme-immunoassay/
- Published: 2018-08-31T12:00:00.000Z
- Updated: 2026-09-15T00:29:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142248

FDA has cleared a Quidel 510(k) for its Sofia 2 Lyme Fluorescent Immunoassay and its use with the Sofia 2 Fluorescent Immunoassay Analyzer for rapid differential detection of human IgM and IgG antibodies to *Borrelia burgdorferi* from finger-stick whole blood specimens to aid in Lyme disease diagnoses. “Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, objective and automated result in as few as three minutes,” the company says. It also is integrated with the company’s Virena data management system, which provides aggregated, de-identified testing data in near real-time.