Clearance Summary
Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit received FDA 510(k) clearance under submission number K151565, sponsored by Cepheid. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2015-10-16.
- Submission: K151565
- Applicant / Sponsor: Cepheid
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.3860
- Decision date: 2015-10-16
Classification & Regulation
This clearance is catalogued under FDA product code OUY and 21 CFR 866.3860, within the Immunology review panel as a Class II device.