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# SpeeDx M. genitalium Test Cleared by FDA
- URL: https://www.fdaweb.com/speedx-m-genitalium-test-cleared-by-fda/
- Published: 2018-04-19T12:00:00.000Z
- Updated: 2026-09-15T00:00:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141259

FDA has cleared a SpeeDx 510(k) for its ResistancePlus MG Positive Control kit, a diagnostic test that simultaneously detects *M. genitalium* and genetic markers for antimicrobial resistance. The kit contains synthetic DNA to simulate *Mycoplasma genitalium*, as well as five mutations known to confer resistance to macrolide antibiotics. Macrolide-resistant *M. genitalium* is a challenging sexually transmitted infection, according to the company. “*M. genitalium* is very difficult to culture, and positive material for quality control can be hard to come by,” the company says. It can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it has been found to have a higher prevalence than gonorrhoea, SpeeDx adds.