Clearance Summary
Xpert Carba-R received FDA 510(k) clearance under submission number K261867, sponsored by Cepheid®. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-07-02.
- Submission: K261867
- Applicant / Sponsor: Cepheid®
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1640
- Decision date: 2026-07-02
Classification & Regulation
This clearance is catalogued under FDA product code POC and 21 CFR 866.1640, within the Microbiology review panel as a Class II device.