Clearance Summary
Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) received FDA 510(k) clearance under submission number K151226, sponsored by Cepheid. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2015-12-03.
- Submission: K151226
- Applicant / Sponsor: Cepheid
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2015-12-03
Classification & Regulation
This clearance is catalogued under FDA product code OCC and 21 CFR 866.3980, within the Microbiology review panel as a Class II device.