510(k) · Cleared
ClearedBioFire JI Control Panel M420
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Molecular Quality Controls, Inc. · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on Jul 22, 2022 as substantially equivalent to K200010 (Maine Molecular Quality Controls, Inc., 2020) after a 582-day review. Its family tree reaches back 4 generations to 2016.
- Decided
- Jul 22, 2022
- Review
- 582 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN150058 (2016). No later device cites it as a predicate yet.
- Root · 4 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 3 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 2 generations backK190222 FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019
- 1 generation backK200010 FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020
- This deviceK203680 BioFire JI Control Panel M420Maine Molecular Quality Controls, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −3 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −2 | K190222 | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. | 2019 | — |
| −1 | K200010 | FilmArray BCID2 Control Panel M416 | Maine Molecular Quality Controls, Inc. | 2020 | — |
| 0 (this device) | K203680 | BioFire JI Control Panel M420 | Maine Molecular Quality Controls, Inc. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PMN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PMN device
- #1 K251526 FilmArray GI Control Panel M238score 13.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200010 | FilmArray BCID2 Control Panel M416Summary page 4…tion: 21 CFR 866.3920 Panel: Microbiology - 83 Product code: PMN Predicate Device K200010; FilmArray BCID2 Control Panel M416, P/N M416, Maine Molecular Quality Controls, Inc. Device Description BioFire JI Control P… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K200010.
How does its category compare?
All PMN devicesPMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PMN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMN
90in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PMN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMN
1in 2023
MAUDE reports naming product code PMN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 59 | 0 | 0 |
| 2019 | 6 | 71 | 1 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 582 | 0 | 0 |
| 2023 | 4 | 90 | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 85 | 0 | — |
What is it indicated for?
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…
Read the full statement (167 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203680: BioFire JI Control Panel M420.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203680
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026