Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

K-Number: K230719 · 2023-04-13

ApplicantBiofire Diagnostics, LLC
Decision Date2023-04-13
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini is a medical device manufactured by Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2023-04-13 under approval number K230719. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini?

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini is a medical device that received FDA 510(k) clearance on 2023-04-13. It is manufactured by Biofire Diagnostics, LLC. The 510(k) number is K230719.

When was BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini approved by the FDA?

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini received FDA 510(k) clearance on 2023-04-13, under approval number K230719.

What company makes BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini?

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini is manufactured by Biofire Diagnostics, LLC.

What is the FDA product code for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini?

The FDA product code for BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini is QOF.

Related Clinical Trials

NCT07513519 Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial RECRUITING

Other Devices by Biofire Diagnostics, LLC

K152579FilmArray Respiratory Panel EZ (RP EZ) K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch K160068FilmArray Respiratory Panel (RP) for use with FilmArray Torch DEN170017FilmArray Respiratory Panel 2 plus (RP2plus)

View all 23 devices →

Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K220963Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑