Cleared Dual Track

K232954 - BIOFIRE SPOTFIRE Respiratory/Sore Throa...

K232954 is the FDA 510(k) clearance for BIOFIRE SPOTFIRE Respiratory/Sore Throa... by Biofire Diagnostics, LLC. It is a Class 2 Microbiology device (product code QOF) cleared through the Dual Track 510(k) pathway after a 187-day FDA review.

K232954 · Biofire Diagnostics, LLC · Microbiology device
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Mar 2024
Decision
187d
Days
Class 2
Risk

K232954 is an FDA 510(k) clearance for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel. 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 Cleared decision on March 26, 2024 after a review of 187 days - an extended review cycle.

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 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 Diagnostics, LLC devices

Submission Details

510(k) Number K232954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2023
Decision Date March 26, 2024
Days to Decision 187 days
Submission Type Dual Track
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
85d slower than avg
Panel avg: 102d · This submission: 187d
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 Consultant

bioMerieux, Inc.
Kevin Bourzac

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K232954.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · Hologic, Inc. · Jul 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
K241194 · Biofire Diagnostics, LLC · May 2024
QIAstat-Dx® Respiratory Panel Plus
K233100 · QIAGEN GmbH · May 2024
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
K231758 · Luminex Molecular Diagnostics, Inc. · Mar 2024
LIAISON PLEX Respiratory Flex Assay
K233410 · Luminex Corporation · Mar 2024
Xpert Xpress CoV-2/Flu/RSV plus
K231481 · Cepheid · Aug 2023