# K173171: FilmArray RP2/RP2plus Control Panel

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: Nov 24, 2017 after 56 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: 2 generations back to DEN150058 (2016). 2 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K161573: FilmArray RP EZ Control Panel M265, Maine Molecular Quality Controls, Inc. (2016) Summary page 4.

## Most influential descendants
- K202196: BioFire RP2.1/RP2.1plus Control Panel M441 (2021), 6 descendants of its own
- 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

## Indications for use
FilmArray RP2/RP2plus Control Panel is intended for use 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 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, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae by BioFire's FilmArray® RP2 and RP2plus assays on the FilmArray® 2.0 or the FilmArray® Torch Systems. FilmArray RP2/RP2plus Control Panel is composed of synthetic RNA designed for and intended to be used solely with the FilmArray® RP2 and RP2plus assays. This product is not intended to replace manufacturer controls provided with the test system.

Source page: https://510kreport.com/device/K173171
Methodology: https://510kreport.com/methodology