# K200010: FilmArray BCID2 Control Panel M416

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: Apr 2, 2020 after 91 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: 3 generations back to DEN150058 (2016). 3 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K190222: FilmArray Pneumonia/Pneumoniaplus Control, Maine Molecular Quality Controls, Inc. (2019) Summary page 4.

## Most influential descendants
- 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
- K254166: MDx-Chex for BCN (2026), 0 descendants of its own

## Indications for use
FilmArray BCID2 Control Panel M416 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire® Blood Culture Identification 2 (BCID2) Panel on the FilmArray® systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K200010
Methodology: https://510kreport.com/methodology