# K202196: BioFire RP2.1/RP2.1plus Control Panel M441

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: Jun 24, 2021 after 323 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.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173171: FilmArray RP2/RP2plus Control Panel, Maine Molecular Quality Controls, Inc. (2017) Summary page 4.

## Most influential descendants
- K221253: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control (2023), 3 descendants of its own
- K230868: SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control (2023), 2 descendants of its own
- K251526: FilmArray GI Control Panel M238 (2025), 1 descendant of its own
- K233611: SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) (2024), 1 descendant of its own
- K260577: FilmArray TF Control Panel M527 (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K202196
Methodology: https://510kreport.com/methodology