Not Cleared Direct

DEN170041 - GeneSTAT.MDx Coccidioides Assay (FDA 510(k) Clearance)

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

DEN170041 · Dxna, LLC · Microbiology device
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Nov 2017
Decision
120d
Days
Class 2
Risk

DEN170041 is an FDA 510(k) submission (not cleared) for the GeneSTAT.MDx Coccidioides Assay. Classified as Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens (product code QAA), Class II - Special Controls.

Submitted by Dxna, LLC (St George, US). The FDA issued a Not Cleared (DENG) decision on November 29, 2017 after a review of 120 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3376 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

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Submission Details

510(k) Number DEN170041 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 01, 2017
Decision Date November 29, 2017
Days to Decision 120 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 102d · This submission: 120d
Pathway characteristics

Device Classification

Product Code QAA Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3376
Definition A Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens Is A Qualitative Test For The Detection Of Coccidioides Spp. Nucleic Acids Directly In Clinical Respiratory Specimens From Patients With Signs And Symptoms Of Coccidioidomycosis And Suspicion Of Infection.
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.