Clearance Summary
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 received FDA 510(k) clearance under submission number K162895, sponsored by Roche Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2017-01-18.
- Submission: K162895
- Applicant / Sponsor: Roche Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2017-01-18
Classification & Regulation
This clearance is catalogued under FDA product code MMI and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.