Cleared Traditional

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE

K020576 · Id Biomedical Corp. · Microbiology
May 2002
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K020576 is an FDA 510(k) clearance for the VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE, a System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (Class II — Special Controls, product code NIJ), submitted by Id Biomedical Corp. (Bothell, US). The FDA issued a Cleared decision on May 1, 2002, 69 days after receiving the submission on February 21, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K020576 FDA.gov
FDA Decision Cleared 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

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