Cleared Traditional

K220870 - BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel (FDA 510(k) Clearance)

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

K220870 · Biofire Defense, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
209d
Days
Class 2
Risk

K220870 is an FDA 510(k) clearance for the BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global.... Classified as Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness (product code QMV), Class II - Special Controls.

Submitted by Biofire Defense, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 20, 2022 after a review of 209 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3966 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biofire Defense, LLC devices

Submission Details

510(k) Number K220870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2022
Decision Date October 20, 2022
Days to Decision 209 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 102d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3966
Definition A Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness Is Identified As A In Vitro Device Intended For The Detection And Identification Of Microbial Agents In Human Clinical Specimens From Patients With Signs And Symptoms Of Acute Febrile Illness Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. It Is Intended To Aid In The Diagnosis Of Acute Febrile Illness In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data, Including Patient Travel, Pathogen Endemicity, 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.