Cleared Traditional

K102416 - BD GENEOHM VANR ASSAY

K102416 is an FDA 510(k) clearance for BD GENEOHM VANR ASSAY, manufactured by Bd Diagnostics Science. The device is a Class 2 Microbiology device with product code NIJ cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K102416 · Bd Diagnostics Science · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
422d
Days
Class 2
Risk

K102416 is an FDA 510(k) clearance for the BD GENEOHM VANR ASSAY. Classified as System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (product code NIJ), Class II - Special Controls.

Submitted by Bd Diagnostics Science (Sparks, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

FDA 510(k) Submission Details - K102416

510(k) Number K102416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2010
Decision Date October 20, 2011
Days to Decision 422 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 102d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NIJ Device Classification - Class 2, Special Controls

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

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K102416 · BD GENEOHM VANR ASSAY
Download PDF FDA Summary Bd Diagnostics Science