# K161573: FilmArray RP EZ Control Panel M265

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: Sep 2, 2016 after 87 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: 1 generation back to DEN150058 (2016). 1 ancestor in all.
25 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150058: Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak, Bio-Rad Laboratories (2016) Summary page 4.

## Most influential descendants
- K190222: FilmArray Pneumonia/Pneumoniaplus Control (2019), 8 descendants of its own
- K200010: FilmArray BCID2 Control Panel M416 (2020), 7 descendants of its own
- K173171: FilmArray RP2/RP2plus Control Panel (2017), 7 descendants of its own
- K163522: FilmArray Warrior Control Panel M290 (2017), 7 descendants of its own
- K202196: BioFire RP2.1/RP2.1plus Control Panel M441 (2021), 6 descendants of its own

## Indications for use
FilmArray RP EZ Control Panel M265 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 H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae on the FilmArray RP EZ assay performed on the FilmArray systems. FilmArray RP Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray RP EZ assay. This product is not intended to replace manufacturer controls provided with the device.

Source page: https://510kreport.com/device/K161573
Methodology: https://510kreport.com/methodology