# K203680: BioFire JI Control Panel M420

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: Jul 22, 2022 after 582 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: 4 generations back to DEN150058 (2016). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200010: FilmArray BCID2 Control Panel M416, Maine Molecular Quality Controls, Inc. (2020) Summary page 4.

## Indications for use
BioFire JI Control Panel M420 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 gram-positive and gram-negative bacteria: Anaerococcus prevotii/vaginalis, Clostridium perfringens, Cutibacterium avidum/granulosum, Enterococcus faecalis, Enterococcus faecium, Finegoldia magna, Parvimonas micra, Peptoniphilus, Peptostreptococcus anaerobius, Staphylococcus aureus, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Bacteroides fragilis, Citrobacter, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Kingella kingae, Klebsiella aecrogenes, Klebsiella pneumoniae group, Morganella morganii, Neisseria gonorrhoeae, Proteus spp., Pseudomonas aeruginosa, Salmonella spp., and Serratia marcescens, antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM, and yeast pathogens: Candida and Candida albicans on the BioFire JI Panel assay on the BioFire systems. BioFire JI Control Panel M420 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire JI Panel assay. This product is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K203680
Methodology: https://510kreport.com/methodology