Not Cleared Direct

DEN200031 - BioFire Respiratory Panel 2.1 (RP2.1) (FDA 510(k) Clearance)

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

DEN200031 · Biofire Diagnostics, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
302d
Days
Class 2
Risk

DEN200031 is an FDA 510(k) submission (not cleared) for the BioFire Respiratory Panel 2.1 (RP2.1). Classified as Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents (product code QOF), Class II - Special Controls.

Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Not Cleared (DENG) decision on March 17, 2021 after a review of 302 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - 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 302 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 Biofire Diagnostics, LLC devices

Submission Details

510(k) Number DEN200031 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 19, 2020
Decision Date March 17, 2021
Days to Decision 302 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 102d · This submission: 302d
Pathway characteristics

Device Classification

Product Code QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3981
Definition A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The Sars-cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-target Test Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 And Other Microbial Agents When In A Multi-target Test In Human Clinical Respiratory Specimens From Patients Suspected Of Respiratory Infection Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. The Device Is Intended To Aid In The Diagnosis Of Respiratory Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.
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 - QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

All 30
Devices cleared under the same product code (QOF) and FDA review panel - the closest regulatory comparables to DEN200031.
VELO Respiratory Test
K251742 · Lex Diagnostics Limited · Feb 2026
LIAISON NES FLU A/B, RSV & COVID-19
K251978 · Diasorin Molecular, LLC · Dec 2025
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)
K252387 · Diasorin Molecular, LLC · Oct 2025
QIAstat-Dx Respiratory Panel Plus
K250080 · QIAGEN GmbH · Aug 2025
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
K243544 · Biofire Diagnostics, LLC · Aug 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
K243455 · Roche Molecular Systems, Inc. · Jul 2025