Not Cleared Direct

DEN200040 - OMNIgene GUT Dx (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200040 · DNA Genotek, Inc. · Microbiology device
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Nov 2021
Decision
506d
Days
Class 2
Risk

DEN200040 is an FDA 510(k) submission (not cleared) for the OMNIgene GUT Dx. Classified as Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples (product code QPO), Class II - Special Controls.

Submitted by DNA Genotek, Inc. (Ottawa, CA). The FDA issued a Not Cleared (DENG) decision on November 3, 2021 after a review of 506 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2952 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 506 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all DNA Genotek, Inc. devices

Submission Details

510(k) Number DEN200040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 15, 2020
Decision Date November 03, 2021
Days to Decision 506 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
404d slower than avg
Panel avg: 102d · This submission: 506d
Pathway characteristics

Device Classification

Product Code QPO Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2952
Definition A Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples Is A Device That Consists Of A Container And Reagents Intended To Stabilize Microbial Nucleic Acids For The Subsequent Assessment Of The Relative Abundance Of Microbial Nucleic Acids (i.e., Microbiome) In Human Specimens By An Assay Validated For Use With The Device. The Device May Also Be Indicated For Sample Collection. The Device Is Not Intended For Preserving Morphology Or Viability Of Microorganisms.
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.