Clearance Summary
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems received FDA 510(k) clearance under submission number K161619, 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 2016-08-29.
- Submission: K161619
- Applicant / Sponsor: Cepheid
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.3860
- Decision date: 2016-08-29
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.