# K263054: BIOFIRE Respiratory Panel 2.1 (RP2.1)

- Pathway: 510(k) (Special)
- Applicant: Biofire Diagnostics
- Decided: Sep 22, 2026 after 21 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.
No later device cites it as a predicate yet.
0 of 2 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 6.

## Indications for use
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY TORCH systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19. The following organism types and subtypes are identified using the BIOFIRE RP2.1: • Adenovirus • Coronavirus 229E • Coronavirus HKU1 • Coronavirus NL63 • Coronavirus OC43 • Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) • Human Metapneumovirus • Human Rhinovirus/Enterovirus • Influenza A, including subtypes H1, H1-2009, and H3 • Influenza B • Parainfluenza Virus 1 • Parainfluenza Virus 2 • Parainfluenza Virus 3 • Parainfluenza Virus 4 • Respiratory Syncytial Virus • Bordetella parapertussis • Bordetella pertussis • Chlamydia pneumoniae • Mycoplasma pneumoniae Nucleic acids from the respiratory 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 is indicative of the presence of the identified microorganism and aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. 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 BIOFIRE RP2.1 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/K263054
Methodology: https://510kreport.com/methodology