Cleared Traditional

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE (K020576) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K020576 · Id Biomedical Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
69d
Days
Class 2
Risk

K020576 is an FDA 510(k) clearance for the VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE. Classified as System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (product code NIJ), Class II - Special Controls.

Submitted by Id Biomedical Corp. (Bothell, US). The FDA issued a Cleared decision on May 1, 2002 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Id Biomedical Corp. devices

Submission Details

510(k) Number K020576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2002
Decision Date May 01, 2002
Days to Decision 69 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 102d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Devices cleared under the same product code (NIJ) and FDA review panel - the closest regulatory comparables to K020576.
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