K243405 is an FDA 510(k) clearance for the Xpert vanA. 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 November 21, 2024, 20 days after receiving the submission on November 1, 2024.
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 | K243405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2024 |
| Decision Date | November 21, 2024 |
| Days to Decision | 20 days |
| Submission Type | Special |
| 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 |