510(k) K092953
K092953 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert VanA Assay". The FDA issued a decision of Substantially Equivalent on December 17, 2009. 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
- December 17, 2009
- Date Received
- September 24, 2009
- Clearance Type
- Traditional
- 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