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 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, Chlamydia pneumonia, and Mycoplasma pneumoniae by BioFire's FilmArray® RP2 and RP2plus assays on 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.

Device Description

FilmArray RP2/RP2plus Control Panel, P/N M315, is a quality control panel consisting of controls, FilmArray RP2/RP2plus Positive (Positive Control), P/N M31721, and FilmArray RP2/RP2plus Negative, (Negative Control), P/N M31621. The Positive Control contains noninfectious surrogate control material; a solution of synthetic RNA transcripts in buffers, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the FilmArray® RP2 and RP2plus assays (Table 1. below) on the FilmArray® 2.0 or FilmArray® Torch systems. The RNA in the Negative Control is non-specific RNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray RP2/RP2plus Control Panel M265 is processed separately according to FilmArray® RP2 and RP2plus assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

AI/ML Overview

The document describes the FilmArray RP2/RP2plus Control Panel, an assayed quality control material for clinical microbiology assays. The acceptance criteria and the study proving the device meets these criteria are detailed, focusing on its performance in monitoring BioFire's FilmArray® RP2 and RP2plus assays.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FilmArray RP2/RP2plus Control Panel are implied by the performance metrics reported in the summary tables. The primary acceptance criteria appear to be:

Correct Positive Control Result: All respiratory pathogen analytes in the Positive Control should be correctly detected.
Correct Negative Control Result: No respiratory pathogens should be detected.
Low Invalid Rate: A low or zero percentage of invalid results.

Acceptance Criteria	Reported Device Performance (Internal & External Studies Combined)
Percent Correct Positive Control Results	100% (150/150)
Percent Correct Negative Control Results	99.4% (150/151)
Percent Invalid Results	0% (0/301)

2. Sample Size and Data Provenance

The study involved both an internal and an external study.

Internal Study (MMQCI):
- Sample Size: 121 tests (60 Positive Controls, 61 Negative Controls)
- Provenance: Retrospective data from MMQCI (Saco, Maine, USA) over 20 days, involving 4 pouch lots and 4 operators.
External Study (Clinical Sites):
- Sample Size: 180 tests (90 Positive Controls, 90 Negative Controls)
- Provenance: Retrospective data from 3 CLIA-certified clinical sites (country not specified, but likely USA given FDA submission) between July and August 2017, over a period of 10 days, using 3 FilmArray RP2 pouch lots and multiple operators.

Combined Test Set Sample Size: 301 total tests (150 Positive Control, 151 Negative Control)

3. Number of Experts and Qualifications for Ground Truth

This device is an assayed quality control material for an in vitro diagnostic (IVD) test, not an AI or imaging device requiring expert interpretation of medical images. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of medical image interpretation (e.g., radiologists) does not apply here.

The "ground truth" for this device is the known composition of the control panel:

Positive Control: Contains synthetic RNA transcripts for specific respiratory pathogens. The ground truth is that these pathogens should be detected.
Negative Control: Contains non-specific RNA. The ground truth is that no specific respiratory pathogens should be detected.

The performance of the device is evaluated against this pre-defined, engineered ground truth. There are no "experts" establishing clinical diagnoses for the test set.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is pre-defined by the engineered composition of the control material, not through human interpretation or adjudication processes like 2+1 or 3+1 that are common in AI or diagnostic studies where human agreement is required to establish a consensus diagnosis for real patient data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The device is a quality control material, not a diagnostic device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its evaluation.

6. Standalone Performance

Yes, the performance data presented is for the standalone performance of the FilmArray RP2/RP2plus Control Panel when run on the BioFire FilmArray® RP2 and RP2plus assays. The results indicate how well the control panel itself triggers the expected (positive or negative) outcome on the assay. The study assesses the characteristics of the control material, not how the control material assists humans in interpreting an assay result. The control material validates the assay's performance, ensuring its reliability.

7. Type of Ground Truth Used

The ground truth used is the engineered composition or known content of the control materials.

For the Positive Control, the ground truth is the presence of specific synthetic RNA sequences designed to be detected by the FilmArray® RP2/RP2plus assays.
For the Negative Control, the ground truth is the absence of these specific RNA sequences.

This is a form of analytical gold standard based on the intentional design and manufacturing of the control reagents.

8. Sample Size for the Training Set

Not applicable. The FilmArray RP2/RP2plus Control Panel is a manufactured reagent product, not an AI algorithm that requires a training set. The performance studies described are for validation and verification of the manufactured product's consistency and effectiveness as a quality control.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device. The "ground truth" for the control materials is inherent in their design and manufacturing specifications.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 24, 2017

Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072

Re: K173171

Trade/Device Name: FilmArray RP2/RP2plus Control Panel Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: September 27, 2017 Received: September 29, 2017

Dear Joan Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Uwe Scherf -S

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173171

Device Name FilmArray RP2/RP2plus Control Panel

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in bold, capitalized letters, with "MAINE MOLECULAR QUALITY CONTROLS, INC." written in smaller font beneath it. A stylized, golden brushstroke-like design is placed to the left of the text, adding a visual element to the logo.

23 Mill Brook Road Mill Brook Business Park Saco, Maine 04072 www.mmaci.com Phone: 207-885-1072 Fax: 207-885-1079

510 (k) Summary

510(k) Number: K173171

Purpose for submission: New product

Applicant Information:

Applicant:	Maine Molecular Quality Controls, Inc.
Address:	23 Mill Brook RoadSaco, Maine 04072

Contact Person:	Joan Gordon, President MMQCI
Phone:	207-885-1072 extension 201
Fax:	207-885-1079
Email Address:	jgordon@mmqci.com

Preparation Date: September 27, 2017

Device

Device Trade Name:	FilmArray RP2/RP2plus Control Panel
Device Common Name:	Quality Control Material for Microbiology Assays
Device Type:	Assayed quality control material for clinical microbiology assays
Class:	Class II (Special controls)
Regulation:	21 CFR 866.3920
Panel:	Microbiology - 83
Product code:	PMN

Predicate Device

K161573; FilmArray RP EZ Control Panel M265, Maine Molecular Quality Controls, Inc.

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MM" in a dark red color, followed by "QCI" in gold. To the left of the letters is a gold, abstract design that looks like a brush stroke. Below the letters is the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", in a smaller font.

separately according to FilmArray® RP2 and RP2plus assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

Respiratory Pathogens
Adenovirus	Parainfluenza Virus 1
Coronavirus 229E	Parainfluenza Virus 2
Coronavirus HKU1	Parainfluenza Virus 3
Coronavirus NL63	Parainfluenza Virus 4
Coronavirus OC43	Respiratory Syncytial Virus
Human Metapneumovirus	Bordetella parapertussis (IS001)
Human Rhinovirus/ Enterovirus	Bordetella pertussis (ptxP)
Influenza A, subtypes H1, H1-2009, H3	Chlamydia pneumoniae
Influenza B	Mycoplasma pneumoniae
Middle East Respiratory Syndrome Coronavirus*

Table 1. Respiratory pathogens detected by FilmArray RP2 and RP2plus assays

*Detected by FilmArray RP2plus assay only.

Device Intended 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, 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.

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Image /page/5/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the acronym "MMQCI" in a stylized font, with "MM" in a dark red color and "QCI" in a slightly lighter shade of red. Below the acronym, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.", is written in a smaller, sans-serif font. A golden, abstract graphic element is positioned to the left of the text, adding a visual flair to the logo.

Substantial Equivalence

Characteristic	Candidate Device:FilmArray RP2/RP2plusControl Panel	Predicate Device:FilmArray RP EZControl Panel M265(K161573)
Intended Use	External assayed qualitycontrol to monitor in vitrolab nucleic acid test	Same
Physical format	Ready-to-Use Liquid	Same
Directions for Use	Process like patient sample	Same
Composition	Synthetic RNA transcripts	Same
Assay Steps Monitored	Reverse transcription.amplification, detection,identification	Same
Number of targetsmonitored in one assay	Multiple	Same

Summary Performance Data

All Test Results

Three lots of FilmArray RP2/RP2plus Control Panel, FilmArray RP2/RP2plus Positive (Positive Control), P/N M31721, and FilmArray RP2/RP2plus Negative Control), P/N M31621, were manufactured by MMQCI. Internal and external studies were performed by testing the 3 lots with the FilmArray® RP2plus assay on the FilmArray System.

The internal study was performed by testing the 3 lots at MMQCI (Saco, Maine) over 20 days with 4 pouch lots by four operators. An external study was performed to assess performance of the FilmArray RP2/RP2plus Control Panel in a clinical setting. The external performance study tested the 3 lots of FilmArray RP2/RP2plus Control Panel at 3 CLIA-certified clinical sites over a period of 10 days using 3 FilmArray pouch lots, incorporating multiple operators.

All FilmArray RP2/RP2plus Positive control respiratory pathogen analytes were correctly detected in the internal and external study (Correct Positive Control Result). All but 1 FilmArray Negative Control gave Correct Negative Control Results of no respiratory pathogens detected for both studies. The incorrect Negative Control result was a false positive HRV/ EV seen when Negative Control was tested at MMQCI.

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Table 2. Summary of All Test Results: Internal and External Sites
Numberof Sites	TotalTests	Invalid	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrectPositiveControl	CorrectNegativeControlResult	IncorrectNegativeControlResult	PercentCorrectNegativeControl
4	301	0	150	0	100%	150	1	99.4%

External Site Testing

A total of 180 FilmArray RP2/RP2plus Control Panel samples were tested between July 2017 and August 2017 at 3 clinical sites. Three lots of Positive Control (C11MAY17, G12JUN17, B21JUN17) and three lots of Negative Control (B11MAY17, F12JUN17, A21JUN17) were tested on three different FilmArray RP2 pouch lots (testing was performed using an IUO pouch module that reported all analyte results; this is equivalent to the RP2plus product) across the 3 sites, incorporating multiple operators. Three Positive Controls and three Negative Controls were run per day/per site and testing spanned a period of 10 days. Not all testing days were consecutive. All 180 controls tested were successful on the first attempt (180/180, 100.0%).

Results and Conclusion:

All FilmArray RP2/RP2plus Positive controls and all FilmArray RP2/RP2plus Negative controls gave correct results. Controls performed robustly at all 3 clinical sites using multiple pouch lots and incorporating multiple operators.

Table 3. Summary of External Results for 3 Control Lots
ExternalSite	TotalTests	Invalid	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrectPositiveControl	CorrectNegativeControlResult	IncorrectNegativeControlResult	PercentCorrectNegativeControl
1	60	0	30	0	100%	30	0	100%
2	60	0	30	0	100%	30	0	100%
3	60	0	30	0	100%	30	0	100%
All Sites	180	0	90	0	100%	90	0	100%

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Image /page/7/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a serif font, with "MM" in a darker shade of brown and "QCI" in a lighter shade. To the left of the letters is a stylized, abstract design in yellow, resembling a brushstroke or a flowing ribbon. Below the letters, in a smaller font, is the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC."

Reproducibilitv

NOTE: The FilmArray 2.0 is a random access instrument. Therefore, 'run' refer to replicates tested on the same day.

Within-run Testing: Within-run reproducibility was demonstrated by 1 operator testing 1 lot each of FilmArray RP2/RP2plus Positive and FilmArray RP2/RP2plus Negative with 1 lot of FilmArray RP2 pouches on the FilmArray 2.0, each within one day at MMQCI. Conclusion: All results were correct and reproducible.

Control	Control Lot #	Number of Tests	Date of Testing	Pouch Lot	Correct Results
FilmArrayRP2/RP2plus Positive	G12JUN17A	6	8/23/2017	606817	6/6
FilmArrayRP2/RP2plus Negative	F12JUN17A	6	8/24/2017	606817	6/6

Precision Testing: Precision was demonstrated by testing 3 lots of FilmArray RP2/RP2plus Positive control and 3 lots of FilmArray RP2/RP2plus Negative control at MMQCI over 20 days with 4 pouch lots by 4 operators using two FilmArray® 2.0 instruments. All FilmArray RP2/RP2plus Positive control analytes were correctly detected. No Invalid results were seen. All FilmArray RP2/RP2plus Negative results were correct except for one false positive HRV/ EV.

Conclusion: FilmArray RP2/RP2plus Control Panel is a reproducible control set across control lots and reagent lots.

Table 5. Summary of Precision Testing for 3 Control Lots at MMQCI
Control	Control Lot #	No. ofTests	Invalid	CorrectResults	IncorrectResults	PercentCorrect
FilmArray RP2/RP2plus Positive	C11MAY17	20	0	20	0	100%
FilmArray RP2/RP2plus Positive	G12JUN17	20	0	20	0	100%
FilmArray RP2/RP2plus Positive	B21JUN17	20	0	20	0	100%
FilmArray RP2/RP2plus Negative	B11MAY17	20	0	20	0	100%
FilmArray RP2/RP2plus Negative	F12JUN17	20	0	20	0	100%
FilmArray RP2/RP2plus Negative	A21JUN17	21	0	20	1	95.2%
	TOTAL	121	0	120	1	99.2%

Regulation Number and Section

§ 866.3920 Assayed quality control material for clinical microbiology assays.

(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”