# K180966: FilmArray Pneumonia Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Diagnostics, LLC
- Decided: Nov 9, 2018 after 210 days
- Product code: QDP (Respiratory Panel)
- Device class: 2
- Regulation: 21 CFR 866.3985
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170047 (2018). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170047: Curetis Unyvero LRT Application, Curetis GmbH (2018) Summary page 7.

## Most influential descendants
- K212727: FilmArray Pneumonia Panel (2021), 1 descendant of its own
- K243222: BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (2024), 0 descendants of its own

## Recalls of this device
- Dec 14, 2023 · Class II · Z-0994-2024: Their is a potential for false positive results when using Pneumonia panel.
- May 8, 2023 · Class II · Z-2440-2023: Due to manufacturing issue, panels may result in false negative results.
- Jun 7, 2021 · Class II · Z-2039-2021: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
- Apr 16, 2021 · Class II · Z-1944-2021: Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

## Indications for use
The FilmArray® Pneumonia Panel is a multiplexed nucleic acid test intended for use with FilmArray®, FilmArray® 2.0, or FilmArray® Torch systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (BAL)-like specimens (BAL or mini-BAL) obtained from individuals suspected of lower respiratory tract infection. The following bacteria are reported semi-quantitatively with bins representing approximately 104 105, 10”6, or >10"7 genomic copies of bacterial nucleic acid per milliliter (copies/mL) of specimen, to aid in estimating relative abundance of nucleic acid from these common bacteria within a specimen: Bacteria reported with bins of 104 10"5, 1076, or 210”7 copies/mL * Acinetobacter calcoaceticus-baumannii complex * Enterobacter cloacae complex * Escherichia coli * Haemophilus influenzae * Klebsiella aerogenes * Klebsiella oxytoca * Klebsiella pneumoniae group * Moraxella catarrhalis * Proteus spp. * Pseudomonas aeruginosa * Serratia marcescens * Staphylococcus aureus * Streptococcus agalactiae * Streptococcus pneumoniae * Streptococcus pyogenes The following atypical bacteria, viruses, and antimicrobial resistance genes are reported qualitatively: Atypical Bacteria * Chlamydia pneumoniae * Legionella pneumophila * Mycoplasma pneumoniae Viruses * Adenovirus * Coronavirus * Human Metapneumovirus * Human Rhinovirus/Enterovirus * Influenza A * Influenza B * Parainfluenza Virus * Respiratory Syncytial Virus Antimicrobial Resistance Genes CTX-M IMP KPC NDM OXA-48-like VIM mecA/C and MREJ The detection and identification of specific viral and bacterial nucleic acids, as well as the estimation of relative abundance of nucleic acid from common bacterial analytes, within specimens collected from individuals exhibiting signs and/or symptoms of a respiratory infection, aids in the diagnosis of lower 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, pathogens below the limit of detection, or in the case of bacterial analytes, present at levels below the lowest reported 1074 copies/mL bin. Detection of analytes does not rule out co-infection with other organisms; the agent(s) detected by the FilmArray Pneumonia 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 lower respiratory tract infection. Detection of bacterial nucleic acid may be indicative of colonizing or normal respiratory flora and may not indicate the causative agent of pneumonia. Semi-quantitative bin (copies/mL) results generated by the FilmArray Pneumonia Panel are not equivalent to CFU/mL and do not consistently correlate with the quantity of bacterial analytes compared to CFU/mL. For specimens with multiple bacteria detected, the relative abundance of nucleic acids (copies/mL) may not correlate with the relative abundance of bacteria as determined by culture (CFU/mL). Clinical correlation is advised to determine significance of semi-quantitative bin (copies/mL) for clinical management. The antimicrobial resistance gene detected may or may not be associated with the agent(s) responsible for disease. Negative results for these antimicrobial resistance gene assays do not indicate susceptibility to corresponding classes of antimicrobials, as multiple mechanisms of antimicrobial resistance exist. Antimicrobial resistance can occur via multiple mechanisms. A "Not Detected" result for a genetic marker of antimicrobial resistance does not indicate susceptibility to associated antimicrobial drugs or drug classes. A "Detected" result for a genetic marker of antimicrobial resistance cannot be definitively linked to the microorganism(s) detected. Culture is required to obtain isolates for antimicrobial susceptibility testing, and FilmArray Pneumonia Panel results should be used in conjunction with culture results for determination of bacterial susceptibility or resistance. Due to the genetic similarity between human rhinovirus and enterovirus, the test cannot reliably differentiate them. A positive Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. Culture is required to identify pathogens not detected by the FilmArray Pneumonia Panel, to further speciate analytes in genus, complex, or group results if desired, to identify bacterial pathogens present below the 10”4 copies/mL bin if desired, and for antimicrobial susceptibility testing.

Source page: https://510kreport.com/device/K180966
Methodology: https://510kreport.com/methodology