Clearance Summary
Xpert C. difficile/Epi received FDA 510(k) clearance under submission number K243730, sponsored by Cepheid®. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-02-28.
- Submission: K243730
- Applicant / Sponsor: Cepheid®
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3130
- Decision date: 2025-02-28
Classification & Regulation
This clearance is catalogued under FDA product code OZN and 21 CFR 866.3130, within the Microbiology review panel as a Class II device.