510(k) K243405
K243405 is an FDA 510(k) premarket notification submitted by Cepheid® for the device "Xpert vanA". The FDA issued a decision of Substantially Equivalent on November 21, 2024. The device falls under product code NIJ (System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species), a Class II device regulated under 21 CFR 866.1640. Cepheid® has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2024
- Date Received
- November 1, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology