System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
The Genotypic Detection System for Resistant Markers in Enterococcus Species is an in vitro diagnostic device 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. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NIJ and regulation 21 CFR 866.1640 in the Microbiology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- NIJ
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243405 | Xpert vanA | Nov 21, 2024 | Substantially Equivalent | Cepheid® |
| K123753 | IMDX VANR FOR ABBOTT M2000 | Jul 17, 2013 | Substantially Equivalent | Intelligent Medical Devices, Inc. |
| K102416 | BD GENEOHM VANR ASSAY | Oct 20, 2011 | Substantially Equivalent | Bd Diagnostics Science |
| K092953 | Xpert VanA Assay | Dec 17, 2009 | Substantially Equivalent | Cepheid |
| K061686 | IDI-VANR ASSAY | Aug 30, 2006 | Substantially Equivalent | Geneohm Sciences Canada, Inc. |
| K020576 | VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE | May 01, 2002 | Substantially Equivalent | Id Biomedical Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.