FilmArray RP2/RP2plus Control Panel

K173171 · Maine Molecular Quality Controls, Inc. · PMN · Nov 24, 2017 · Microbiology

Device Facts

• Record ID: K173171
• Device Name: FilmArray RP2/RP2plus Control Panel
• Applicant: Maine Molecular Quality Controls, Inc.
• Product Code: PMN · Microbiology
• Decision Date: Nov 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

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.

Device Story

FilmArray RP2/RP2plus Control Panel consists of liquid positive and negative controls; positive control contains noninfectious synthetic RNA transcripts representing respiratory pathogens; negative control contains non-specific RNA in buffers/stabilizers. Used in clinical laboratories to monitor performance of BioFire FilmArray RP2/RP2plus assays on FilmArray 2.0 or Torch systems. Controls are processed by laboratory personnel identically to patient nasopharyngeal swab samples in Viral Transport Media. The device monitors the entire assay process, including reverse transcription, amplification, detection, and identification. Successful detection of control analytes confirms proper system function and reagent integrity. Benefits include verification of test accuracy and reliability for clinical diagnostic workflows.

Clinical Evidence

Bench testing performed across 3 CLIA-certified clinical sites and internal studies. Total of 301 tests conducted (180 external, 121 internal). Primary endpoints were correct detection of positive and negative control analytes. Results: 100% (150/150) correct positive control detection; 99.4% (149/150) correct negative control detection (one false positive HRV/EV observed in internal study). No invalid results reported. Study confirms reproducibility across multiple operators, pouch lots, and control lots.

Technological Characteristics

Ready-to-use liquid control panel. Positive control: synthetic RNA transcripts in buffers, stabilizers, and preservatives. Negative control: non-specific RNA in buffers, stabilizers, and preservatives. Single-use packaging. Storage at -20°C or colder. No specific ASTM standards cited.

Indications for Use

Indicated for use as external positive and negative assayed quality control materials for laboratory nucleic acid testing of respiratory pathogens (Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A/B, MERS-CoV, Parainfluenza, RSV, Bordetella, Chlamydia pneumoniae, Mycoplasma pneumoniae) using BioFire FilmArray RP2/RP2plus assays. For prescription use only.

Regulatory Classification

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.

Special Controls

An assayed quality control material for clinical microbiology assays must comply with the following special controls: (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; Expected values: (ii) Analyte source: (iii) (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., realtime 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 in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(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; (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 21 CFR 809.10(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."

*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.”

Predicate Devices

• FilmArray RP EZ Control Panel M265 (K161573)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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: [phone] Fax: [phone]

510 (k) Summary

### 510(k) Number: K173171

Purpose for submission: New product

### Applicant Information:

| Applicant: | Maine Molecular Quality Controls, Inc. |
|------------|-----------------------------------------|
| Address: | 23 Mill Brook Road<br>Saco, Maine 04072 |

| Contact Person: | Joan Gordon, President MMQCI |
|-----------------|------------------------------|
| Phone: | 207-885-1072 extension 201 |
| Fax: | 207-885-1079 |
| Email Address: | [e-mail] |

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

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

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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:<br>FilmArray RP2/RP2plus<br>Control Panel | Predicate Device:<br>FilmArray RP EZ<br>Control Panel M265<br>(K161573) |
|---------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | External assayed quality<br>control to monitor in vitro<br>lab 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.<br>amplification, detection,<br>identification | Same |
| Number of targets<br>monitored 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 | | | | | | | | |
|-------------------------------------------------------------------|----------------|---------|------------------------------------------|--------------------------------------------|-------------------------------------------|------------------------------------------|--------------------------------------------|-------------------------------------------|
| Number<br>of Sites | Total<br>Tests | Invalid | Correct<br>Positive<br>Control<br>Result | Incorrect<br>Positive<br>Control<br>Result | Percent<br>Correct<br>Positive<br>Control | Correct<br>Negative<br>Control<br>Result | Incorrect<br>Negative<br>Control<br>Result | Percent<br>Correct<br>Negative<br>Control |
| 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 | | | | | | | | |
|---------------------------------------------------------|----------------|---------|------------------------------------------|--------------------------------------------|-------------------------------------------|------------------------------------------|--------------------------------------------|-------------------------------------------|
| External<br>Site | Total<br>Tests | Invalid | Correct<br>Positive<br>Control<br>Result | Incorrect<br>Positive<br>Control<br>Result | Percent<br>Correct<br>Positive<br>Control | Correct<br>Negative<br>Control<br>Result | Incorrect<br>Negative<br>Control<br>Result | Percent<br>Correct<br>Negative<br>Control |
| 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 |
|-----------------------------------|---------------|-----------------|-----------------|-----------|-----------------|
| FilmArray<br>RP2/RP2plus Positive | G12JUN17A | 6 | 8/23/2017 | 606817 | 6/6 |
| FilmArray<br>RP2/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. of<br>Tests | Invalid | Correct<br>Results | Incorrect<br>Results | Percent<br>Correct |
| 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% |