# K213954: BIOFIRE SPOTFIRE Respiratory (R) Panel

- Pathway: 510(k) (Dual Track)
- Applicant: Biofire Diagnostics
- Decided: Feb 3, 2023 after 413 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: 1 generation back to DEN200031 (2021). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200031: BioFire Respiratory Panel 2.1 (RP2.1), Biofire Diagnostics, LLC (2021) Summary page 5.

## Most influential descendants
- K232954: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel (2024), 2 descendants of its own
- K230719: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (2023), 2 descendants of its own
- K241194: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini (2024), 1 descendant of its own
- K251978: Liaison Nes Flu a/B, RSV & Covid-19 (2025), 0 descendants of its own
- K243544: BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini (2025), 0 descendants of its own

## Indications for use
The BIOFIRE® SPOTFIRE® Respiratory (R) Panel (SPOTFIRE R Panel) is a 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) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. The following organism types and subtypes are identified and differentiated using the SPOTFIRE R Panel: Viruses: Adenovirus Coronavirus (seasonal) Coronavirus SARS-CoV-2 Human metapneumovirus Human rhinovirus/enterovirus Influenza A virus Influenza A virus A/H1-2009 Influenza A virus A/H3 Influenza B virus Parainfluenza virus Respiratory syncytial virus Bacteria: Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae Nucleic acids from the viral and bacterial organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection are 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 may be due to infection with pathogens that are not detected by this test, or lower respiratory tract infection that may not be detected by an NPS specimen. Positive results do not rule out coinfection with other organisms. The agent(s) detected by the SPOTFIRE R Panel 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.

Source page: https://510kreport.com/device/K213954
Methodology: https://510kreport.com/methodology