510(k) · Cleared
ClearedBioFire RP2.1/RP2.1plus Control Panel M441
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 Jun 24, 2021 as substantially equivalent to K173171 (Maine Molecular Quality Controls, Inc., 2017) after a 323-day review. Its family tree reaches back 3 generations to 2016. 6 later devices descend from it.
- Decided
- Jun 24, 2021
- Review
- 323 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN150058 (2016). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 2 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 1 generation backK173171 FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017
- This deviceK202196 BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK221253 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK230868 SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control…Maine Molecular Quality Controls, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK251526 FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK233611 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive…Maine Molecular Quality Controls, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260577 FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. · 2023 · cites it directly3descendants
- K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative…Maine Molecular Quality Controls, Inc. · 2023 · 2 generations on2descendants
- K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc. · 2025 · cites it directly1descendant
- K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…Maine Molecular Quality Controls, Inc. · 2024 · 3 generations on1descendant
- K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −2 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −1 | K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | 2017 | — |
| 0 (this device) | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021 | — |
| +1 | K221253 | SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2023 | — |
| +2 | K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE®… | Maine Molecular Quality Controls, Inc. | 2023 | — |
| +1 | K251526 | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | 2025 | — |
| +3 | K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control… | Maine Molecular Quality Controls, Inc. | 2024 | — |
| +2 | K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K173171 | FilmArray RP2/RP2plus Control PanelSummary page 4…Regulation: 21 CFR 866.3920 Panel: Microbiology - 83 Product code: PMN Predicate Device K173171; FilmArray RP2/RP2plus Control Panel, P/N 315 Device Description BioFire RP2.1/RP2.1plus Control Panel M441, P/N M441, is a qual… | 2017 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221253 (Maine Molecular Quality Controls, Inc., 2023) has gone furthest, with 3 descendants of its own.
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. 2021, 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 RP2.1/RP2.1plus Control Panel M441 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 Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome…
Read the full statement (151 words)
BioFire RP2.1/RP2.1plus Control Panel M441 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 Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1 plus (RP2.1plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assay performed on the BioFire FilmArray systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1, BioFire RP2.1plus and BioFire RP2.1-EZ 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/K202196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202196: BioFire RP2.1/RP2.1plus Control Panel M441.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202196
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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