BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
FDA 510(k) K241194 · Biofire Diagnostics, LLC
Submission
- Device name
- BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
- Applicant
- Biofire Diagnostics, LLC
Salt Lake City, UT, US - Received
- April 30, 2024
- Decision date
- May 30, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3981
- Specialty
- Microbiology
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…
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| K252932 | Fast PCR Mini Respiratory PanelQOF · Dual Track | Autonomous Medical Devices Incorporated | 06/12/2026SE |
| K252269 | FINDER Flu A&B/SARS-CoV-2 TestQOF · Dual Track | Baebies, Inc. | 03/30/2026SE |
| K251742 | VELO Respiratory TestQOF · Dual Track | Lex Diagnostics Limited | 02/13/2026SE |
| K251978 | Liaison Nes Flu A/B, RSV & COVID-19QOF · Dual Track | Diasorin Molecular, LLC | 12/23/2025SE |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV…QOF · Traditional | Diasorin Molecular, LLC | 10/30/2025SE |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional | QIAGEN GmbH | 08/27/2025SE |
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track | Biofire Diagnostics, LLC | 08/14/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | Roche Molecular Systems, Inc. | 07/31/2025SE |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plusQOF · Special | Cepheid® | 05/01/2025SE |
More from Cepheid®
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|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track | 08/14/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | 01/16/2025SE |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…PEN · Special | 12/20/2024SE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional | 11/07/2024SE |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelQOF · Dual Track | 03/26/2024SE |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniQOF · Special | 04/13/2023SE |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Special | 03/16/2023SE |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) PanelQOF · Dual Track | 02/03/2023SE |
| K222601 | FilmArray Pneumonia Panel plusQDS · Special | 10/27/2022SE |
| K212727 | FilmArray Pneumonia PanelQDP · Special | 09/22/2021SE |
Questions and answers
When was BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini cleared by the FDA?
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini (K241194) received a 510(k) decision of Substantially Equivalent on May 30, 2024, 30 days after the submission was received.
What is the product code of K241194?
The FDA product code is QOF – Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, a Class II (moderate risk) device regulated under 21 CFR 866.3981.