# K170604: FilmArray Respiratory Panel 2 (RP2)

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, LLC
- Decided: May 30, 2017 after 90 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to DEN070013 (2008). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160068: FilmArray Respiratory Panel (RP) for use with FilmArray Torch, Biofire Diagnostics, LLC (2016) Summary page 6.

## Most influential descendants
- K192485: BioCode Respiratory Pathogen Panel (RPP) (2019), 1 descendant of its own
- K172629: Panther Fusion AdV/hMPV/RV Assay (2017), 1 descendant of its own
- K254139: BioCode® Respiratory Pathogen Panel (RPP) (2026), 0 descendants of its own
- K231017: Panther Fusion AdV/hMPV/RV Assay (2023), 0 descendants of its own

## Indications for use
The FilmArray® Respiratory Panel 2 (RP2) is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or 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. The following organism types and subtypes are identified using the FilmArray® RP2: • Adenovirus • Coronavirus 229E • Coronavirus HKU1 • Coronavirus NL63 • Coronavirus OC43 • 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 (IS1001) • Bordetella pertussis (ptxP) • Chlamydia pneumoniae • Mycoplasma pneumoniae The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of a respiratory infection 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 a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the FilmArray® RP2 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. Due to the genetic similarity between Human Rhinovirus and Enterovirus, the FilmArray® RP2 cannot reliably differentiate them. A positive FilmArray® RP2 Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Performance characteristics for Influenza A were established when Influenza A H1-2009 and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K170604
Methodology: https://510kreport.com/methodology