Cleared Traditional

K213362 - BioFire Global Fever Special Pathogens Panel (FDA 510(k) Clearance)

Also includes:
BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213362 · Biofire Defense, LLC · Microbiology device
Download Printable Device Report (PDF)
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Mar 2023
Decision
526d
Days
Class 2
Risk

K213362 is an FDA 510(k) clearance for the BioFire Global Fever Special Pathogens Panel. Classified as Multiplex Nucleic Acid Detection System For Biothreat Agents (product code QVR), Class II - Special Controls.

Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 22, 2023 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.4000 - 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.

View all Biofire Defense, LLC devices

Submission Details

510(k) Number K213362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2021
Decision Date March 22, 2023
Days to Decision 526 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
424d slower than avg
Panel avg: 102d · This submission: 526d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4000
Definition A Multiplex Nucleic Acid Detection System For Biothreat Agents Is A Qualitative In Vitro Diagnostic Test For Detection And Identification Of Nucleic Acids From Biothreat Pathogens In Human Clinical Specimens
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.