Not Cleared Direct

DEN200066 - BioFire Joint Infection (JI) Panel (FDA 510(k) Clearance)

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

DEN200066 · Biofire Diagnostics, LLC · Microbiology device
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Apr 2022
Decision
549d
Days
Class 2
Risk

DEN200066 is an FDA 510(k) submission (not cleared) for the BioFire Joint Infection (JI) Panel. Classified as Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System (product code QSN), Class II - Special Controls.

Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on April 29, 2022 after a review of 549 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3988 - 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 549 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.

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Submission Details

510(k) Number DEN200066 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 27, 2020
Decision Date April 29, 2022
Days to Decision 549 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
447d slower than avg
Panel avg: 102d · This submission: 549d
Pathway characteristics

Device Classification

Product Code QSN Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3988
Definition A Qualitative Nucleic Acid Assay That Detects And Identifies Microbial Organisms And Antimicrobial Resistance Markers In Clinical Specimens To Aid In The Diagnosis Of Orthopedic Infections.
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.