510(k) Report

510(k) · Cleared

Cleared

FilmArray RP EZ Control Panel M265

K161573510(k) TraditionalCleared Sep 2, 201687-day reviewClass II21 CFR 866.3920

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Maine Molecular Quality Controls, Inc. · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Cleared on Sep 2, 2016 as substantially equivalent to DEN150058 (Bio-Rad Laboratories, 2016) after an 87-day review. Its family tree reaches back 1 generation to 2016. 25 later devices descend from it.

Decided
Sep 2, 2016
Review
87 days
Class
Class II
Product code
PMN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN150058 (2016). 25 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2017: 2 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 3 descendants cleared2023: 5 descendants cleared2025: 1 descendant cleared2026: 7 descendants cleared2024: 3 descendants clearedDEN150058 · 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 · 2016201620182020202220242026
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 6 descendants4 generations forward: 8 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant 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 · 20160+5
  1. Root · 1 generation backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
  2. This deviceK161573 FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. · 2016
  3. Descendant · cites it directly · 8 of its ownK190222 FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019
  4. Descendant · 2 generations on · 7 of its ownK200010 FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020
  5. Descendant · cites it directly · 7 of its ownK173171 FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017
  6. Descendant · cites it directly · 7 of its ownK163522 FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017
  7. Descendant · 2 generations on · 6 of its ownK202196 BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc. · 2021

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2017: 22019: 12020: 22021: 12022: 32023: 52024: 32025: 12026: 7
2017high 7 (2026) · low 0 (2018)2026

Most influential descendants

Showing 5 of 25 · See all
  • K190222FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc. · 2019 · cites it directly8descendants
  • K200010FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc. · 2020 · 2 generations on7descendants
  • K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. · 2017 · cites it directly7descendants
  • K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. · 2017 · cites it directly7descendants
  • K202196BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc. · 2021 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level…Bio-Rad Laboratories2016—
0 (this device)K161573FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc.2016—
+1K190222FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc.2019—
+2K200010FilmArray BCID2 Control Panel M416Maine Molecular Quality Controls, Inc.2020—
+1K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc.2017—
+1K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc.2017—
+2K202196BioFire RP2.1/RP2.1plus Control Panel M441Maine Molecular Quality Controls, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201910
202020
202110
202230
202350
202430
202510
202670
FIG. 1 — Lineage of K161573, 2016–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251526 FilmArray GI Control Panel M238score 13.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and…
Summary page 4
…Regulation: 21 CFR 866.3920 Panel: Microbiology - 83 Product code: PMN Predicate Device DEN150058; Amplichek II, Bio-Rad Laboratories Device Description FilmArray RP EZ Control Panel M265, P/N M265, is a quality control pan…
Bio-Rad Laboratories2016—

Also cleared against DEN150058: 3 other devices →

What descends from it? (25)

See all 25

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K190222FilmArray Pneumonia/Pneumoniaplus ControlMaine Molecular Quality Controls, Inc.20198
K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc.20177
K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc.20177

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?

  • Its one ancestor has no recall.
  • Of its descendants, K190222 (Maine Molecular Quality Controls, Inc., 2019) has gone furthest, with 8 descendants of its own.
  • 3 other devices also cite its predicate DEN150058.

How does its category compare?

All PMN devices

PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · PMN

1in 2025

2016: 32017: 22018: 32019: 62020: 22021: 12022: 32023: 42024: 22025: 12026 (partial year): 6
2007high 6 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PMN

90in 2023

2018: 59 days median2019: 71 days median2022: 582 days median2023: 90 days median2026 (partial year): 85 days median
2007high 582 (2022) · low 59 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PMN

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PMN

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code PMN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20163—00
20172—00
201835900
201967110
20202—00
20211—00
2022358200
202349001
20242—00
20251—00
20266850—

What is it indicated for?

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…

Read the full statement (120 words)

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.

Indications for use as stated in the FDA summary.

Also cleared against DEN150058

3 other devices cite the same predicate.

  • K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc. · 2018
  • K181711BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelMicrobiologics, Inc. · 2018
  • K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakBio-Rad Laboratories · 2016

More from Maine Molecular Quality Controls, Inc.

15 FDA decisions under this applicant name. See the company

  • K262573SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative ControlMaine Molecular Quality Controls, Inc. · 2026
  • K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc. · 2026
  • K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc. · 2025
  • K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. · 2024
  • K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative…Maine Molecular Quality Controls, Inc. · 2024

Recent decisions in PMN

The PMN category page

  • K262573SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative ControlMaine Molecular Quality Controls, Inc. · 2026
  • K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC · 2026
  • K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc. · 2026
  • K260041MDx-Chex for BCPStreck, LLC · 2026
  • K254166MDx-Chex for BCNStreck · 2026

https://510kreport.com/device/K161573 · printed Nov 5, 2026

Cite this page

510(k) Report. “K161573: FilmArray RP EZ Control Panel M265.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161573

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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