Velogene Genomic Identificationassay for Vre
510(k) K020576
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020576 | Date1 May 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NIJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Velogene Genomic Identification Assay for VRE is a genotypic detection system designed for the identification of vancomycin-resistant Enterococcus species. Classified as a System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species, this assay leverages molecular techniques to detect resistance markers associated with vancomycin resistance in clinical samples. It provides a rapid and specific method for microbiological identification, supporting targeted antimicrobial therapy decisions in hospital settings.
This assay is intended for use in microbiology laboratories and is supplied as a single-use diagnostic test. It requires no special storage conditions beyond standard laboratory refrigeration and is not intended for MRI environments. The device is cleared by the FDA under 510(k) with the classification of Class II (NIJ product code), ensuring compliance with regulatory standards for genotypic resistance testing. Usage follows the manufacturer’s instructions for genomic identification of vancomycin-resistant Enterococcus strains.
Other devices from Id Biomedical Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Velogene Genomic Identification Assay for VRE used for?
This assay is designed to identify vancomycin-resistant Enterococcus species in clinical samples through genotypic detection of resistance markers. By rapidly confirming VRE presence, it helps clinicians adjust antimicrobial therapy to improve patient outcomes in hospital settings.
How is the Velogene VRE assay supplied and intended for use?
The assay is supplied as a single-use diagnostic test, intended exclusively for microbiology laboratories. It requires no specialized storage beyond standard laboratory refrigeration and is not compatible with MRI environments. Usage follows the manufacturer’s instructions for genomic identification.
Is the Velogene VRE assay sterile and reusable?
The Velogene VRE assay is supplied as a single-use diagnostic test, meaning each kit is intended for one-time use only. Sterility is maintained through its packaging and handling per manufacturer guidelines, ensuring reliability for each test.
What regulatory clearance does the Velogene VRE assay hold?
The Velogene Genomic Identification Assay for VRE is cleared by the FDA under a 510(k) submission, classified as a Class II device under the NIJ product code. This clearance confirms its compliance with regulatory standards for genotypic resistance testing in microbiology.
Are there specific storage requirements for the Velogene VRE assay?
The assay does not require special storage conditions beyond standard laboratory refrigeration. It is designed for use in clinical microbiology labs, where typical refrigeration practices are already in place to maintain sample integrity.