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# FDA Clears Gold Standard Diagnostics Lyme Assay
- URL: https://www.fdaweb.com/fda-clears-gold-standard-diagnostics-lyme-assay/
- Published: 2018-06-13T12:00:00.000Z
- Updated: 2026-09-15T00:12:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141674

FDA has cleared a Gold Standard Diagnostics 510(k) for its *Borrelia burgdorferi* IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC-recommended two-step testing for evidence of antibodies against the Lyme disease bacteria. Both steps can be performed using the same blood sample, according to the company. It screens for *B. burgdorferi* strains B31 and 2591, as well as VIsE, an immunogenic lipoprotein, it says.