# K123620: Filmarray Respiratory Panel (RP)

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, Inc.
- Decided: Feb 11, 2013 after 80 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: 5 generations back to DEN070013 (2008). 6 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103175: Filmarray Respiratory Panel (RP), Idaho Technology, Inc. (2011) Summary page 1.
- K110764: Filmarray RP Panel, Idaho Technology, Inc. (2011) Summary page 4.
- K120267: Filmarray RP Panel, Idaho Technology, Inc. (2012) Summary page 1.

## Most influential descendants
- K143080: FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System (2015), 10 descendants of its own
- K160068: FilmArray Respiratory Panel (RP) for use with FilmArray Torch (2016), 6 descendants of its own
- K133673: Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma (2014), 5 descendants of its own
- K170604: FilmArray Respiratory Panel 2 (RP2) (2017), 4 descendants of its own
- K163626: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (2017), 2 descendants of its own

## Indications for use
FilmArray® Respiratory Panel (RP) is a multiplexed nucleic acid test intended for use with the FilmArray Instrument 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 RP: Adenovirus, Coronavirus 229E, Coronavirus HKU I, Coronavirus NL63, Coronavirus 0C43, Human Metapneumnovirus, In~fluenza A, Influenza A subtype HI, Influenza A subtype H3, Influenza A subtype HI -2009, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Human Rhinovir-us/Enterovirus, Respiratory Syncytial Virus, Bordetellapertussis, Chiamydophila pneumoniae, and Mycoplasia pneutnoniae. The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and 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 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 is not detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the FilmArray RP may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, iminunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Bordetellapertussis, Coronavirus 229E, Coronavirus 0C43, Influenza A I, Influenza A H13, Influenza A i-2009, Influenza B, Mycoplasmapneumoniae,Parainfluenza Virus 1, Paraintluenza Virus 2, and Parainfluenza Virus 4 were established primarily with retrospective clinical specimens. Performance characteristics for Chiamydophilapneumoniae were established primarily using contrived clinical specimens. Due to the genetic similarity between Human Rhinovirus and Enterovimus, the FilmArray RP cannot reliably differentiate them. A positive FilmArray RP Rhinovirus/Enterovirus result should be followed-up using an alternate method (e.g., cell culture or sequence analysis). The FilmArray RtP assay for Coronavirus 0C43 may cross-react with some isolates of Coronavirus HKU L A dual positive result may be due to cross-reactivity or may indicate a co-infection. Performance characteristics for Influenza A were established when Influenza A Hl-2009, A HI, 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 e .merges,. I~f 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/K123620
Methodology: https://510kreport.com/methodology