# K190222: FilmArray Pneumonia/Pneumoniaplus Control

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: May 3, 2019 after 87 days
- Product code: PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150058 (2016). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161573: FilmArray RP EZ Control Panel M265, Maine Molecular Quality Controls, Inc. (2016) Summary page 4.

## Most influential descendants
- K200010: FilmArray BCID2 Control Panel M416 (2020), 7 descendants of its own
- K212576: MDx-Chex for BCID2 (2022), 5 descendants of its own
- K231221: MDx-Chex for BC-GP (2023), 1 descendant of its own
- K231223: MDx-Chex for BC-GN (2023), 1 descendant of its own
- K260041: MDx-Chex for BCP (2026), 0 descendants of its own

## Indications for use
FilmArray Pneumonia/Pneumoniaplus Control is intended for use as an external positive and negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of bacteria: 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, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray systems. FilmArray Pneumonia/Pneumoniaplus Control is composed of synthetic DNA and RNA designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer internal controls provided with the test system.

Source page: https://510kreport.com/device/K190222
Methodology: https://510kreport.com/methodology