K092953 is an FDA 510(k) clearance for the Xpert VanA Assay. This device is classified as a System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (Class II - Special Controls, product code NIJ).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on December 17, 2009, 84 days after receiving the submission on September 24, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. 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.
| 510(k) Number | K092953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2009 |
| Decision Date | December 17, 2009 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NIJ — System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | 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 |