# K243544: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

- Pathway: 510(k) (Dual Track)
- Applicant: Biofire Diagnostics, LLC
- Decided: Aug 14, 2025 after 272 days
- Product code: QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents)
- Device class: 2
- Regulation: 21 CFR 866.3981
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN200031 (2021). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241194: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini, Biofire Diagnostics, LLC (2024) Summary page 6.

## Indications for use
The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini is an automated multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE SPOTFIRE System for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab (NPS) or anterior nasal swab (ANS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19; (Respiratory menu) or in throat swab (TS) specimens from individuals with signs and symptoms of pharyngitis; (Sore Throat menu). The following analytes are identified and differentiated using the BIOFIRE SPOTFIRE R/ST Panel Mini: Respiratory Menu Viruses Coronavirus SARS-CoV-2 Human rhinovirus Influenza A virus Influenza B virus Respiratory syncytial virus Sore Throat Menu Viruses Human rhinovirus Influenza A virus Influenza B virus Respiratory syncytial virus Bacteria Streptococcus pyogenes (group A Strep) Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS/ANS/TS specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and symptoms of respiratory infection and/or pharyngitis is indicative of the presence of the identified microorganism and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness and/or pharyngitis may be due to infection with pathogens that are not detected by this test, or a respiratory tract infection that may not be detected by an NPS, ANS, or TS specimen. Positive results do not rule out co-infection with other organisms. The agent(s) detected by the BIOFIRE SPOTFIRE R/ST Panel Mini may not be the definite cause of disease. Additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection and/or pharyngitis.

Source page: https://510kreport.com/device/K243544
Methodology: https://510kreport.com/methodology