Submission Details
| 510(k) Number | K061686 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 15, 2006 |
| Decision Date | August 30, 2006 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
IDI-VANR ASSAY
Aug 2006
Decision
76d
Days
Class 2
Risk
About This 510(k) Submission
K061686 is an FDA 510(k) clearance for the IDI-VANR ASSAY, a System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (Class II — Special Controls, product code NIJ), submitted by Geneohm Sciences Canada, Inc. (Baldwin, US). The FDA issued a Cleared decision on August 30, 2006, 76 days after receiving the submission on June 15, 2006. 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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