510(k) · Cleared
ClearedSPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
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 May 30, 2024 as substantially equivalent to K233611 (Maine Molecular Quality Controls, Inc., 2024) after a 23-day review. Its family tree reaches back 7 generations to 2016.
- Decided
- May 30, 2024
- Review
- 23 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN150058 (2016). No later device cites it as a predicate yet.
- Root · 7 generations backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- 6 generations backK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
- 5 generations backK173171 FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017
- 4 generations backK202196 BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc. · 2021
- 3 generations backK221253 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. · 2023
- 2 generations backK230868 SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control…Maine Molecular Quality Controls, Inc. · 2023
- 1 generation backK233611 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive…Maine Molecular Quality Controls, Inc. · 2024
- This deviceK241289 SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| −6 | K161573 | FilmArray RP EZ Control Panel M265 | Maine Molecular Quality Controls, Inc. | 2016 | — |
| −5 | K173171 | FilmArray RP2/RP2plus Control Panel | Maine Molecular Quality Controls, Inc. | 2017 | — |
| −4 | K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021 | — |
| −3 | 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 | K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control… | Maine Molecular Quality Controls, Inc. | 2024 | — |
| 0 (this device) | K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE…Summary page 6…www.mmqci.com SECTION 4: Special 510(k) Summary 510(k) Number: Purpose for submission: Changes to existing device (reference K233611) are the addition of BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini to the intended use of SPOTFIRE R… | 2024 |
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 8 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 7 ancestors has a recall.
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. 2024, 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?
The SPOTFIRE® RSP Pos & Neg Controls kit is intended for use (as applicable) 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 Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus, Coronavirus…
Read the full statement (395 words)
The SPOTFIRE® RSP Pos & Neg Controls kit is intended for use (as applicable) 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 Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus, Coronavirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini on the BIOFIRE SPOTFIRE System. SPOTFIRE RSP Pos & Neg Controls is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel, and BIOFIRE SPOTFIRE R/ST Panel Mini assays. The SPOTFIRE RSP Positive Control contains synthetic RNA transcripts in stabilizing solution, and the SPOTFIRE RSP Negative Control contains buffers and preservatives. This product is not intended to replace manufacturer internal controls provided with these devices.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
SPOTFIRE® RSP Negative Control is intended for use (as applicable) as an external negative assayed quality control to monitor performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Streptococcus dysgalactiae (Group C/G Strep), Streptococcus pyogenes (Group A Strep), Adenovirus, Coronavirus SARS-CoV-2, Coronavirus (seasonal), Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A Subtype H1-2009, Influenza A Subtype H3, Influenza B, Parainfluenza Virus and Respiratory Syncytial Virus using the BIOFIRE® SPOTFIRE Respiratory (R) Panel, BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, and BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini on the BIOFIRE SPOTFIRE System. SPOTFIRE RSP Negative Control is designed for and intended to be used solely with the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel, and BIOFIRE SPOTFIRE R/ST Panel Mini assays. SPOTFIRE RSP Negative Control is comprised of a solution of buffer and preservatives that does not contain target analytes. This product is not intended to replace manufacturer internal controls provided with these devices.
Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241289 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241289: SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241289
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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