Submission Details
| 510(k) Number | K102416 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2010 |
| Decision Date | October 20, 2011 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BD GENEOHM VANR ASSAY
Oct 2011
Decision
422d
Days
Class 2
Risk
About This 510(k) Submission
K102416 is an FDA 510(k) clearance for the BD GENEOHM VANR ASSAY, a System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (Class II — Special Controls, product code NIJ), submitted by Bd Diagnostics Science (Sparks, US). The FDA issued a Cleared decision on October 20, 2011, 422 days after receiving the submission on August 24, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.
Device Classification
| 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 |
Manufacturer
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