Cleared Traditional

K061686 - IDI-VANR ASSAY (FDA 510(k) Clearance)

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

K061686 · Geneohm Sciences Canada, Inc. · Microbiology device
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Aug 2006
Decision
76d
Days
Class 2
Risk

K061686 is an FDA 510(k) clearance for the IDI-VANR ASSAY. Classified as System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (product code NIJ), Class II - Special Controls.

Submitted by Geneohm Sciences Canada, Inc. (Baldwin, US). The FDA issued a Cleared decision on August 30, 2006 after a review of 76 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 Geneohm Sciences Canada, Inc. devices

Submission Details

510(k) Number K061686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 102d · This submission: 76d
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 K061686.
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