Clearance Summary
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV received FDA 510(k) clearance under submission number K171552, 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 2017-12-19.
- Submission: K171552
- Applicant / Sponsor: Cepheid
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2017-12-19
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.