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# Zeus Scientific New Indication for 4 Lyme Disease Tests
- URL: https://www.fdaweb.com/zeus-scientific-new-indication-for-4-lyme-disease-tests/
- Published: 2019-07-29T12:00:00.000Z
- Updated: 2026-09-15T01:40:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144640

FDA has cleared 510(k)s for four previously cleared Zeus Scientific tests with new indications to aid in diagnosing Lyme disease. The tests represent the “first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-clears-new-indications-existing-lyme-disease-tests-may-help-streamline-diagnoses?ref=fdaweb.com) says. “These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients.”

The clearances are based on data from clinical studies involving the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, Zeus ELISA Borrelia burgdorferi IgG/IgM Test System, Zeus ELISA Borrelia burgdorferi IgM Test System, and the Zeus ELISA Borrelia burgdorferi IgG Test System. The data showed that this alternative approach, referred to as a modified two-tier test, is as accurate as current methods for detecting antibodies for assessing exposure to *Borrelia burgdorferi*, the causative agent of Lyme disease, over current methods, FDA says.