← Product Code [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN) · K173171

# FilmArray RP2/RP2plus Control Panel (K173171)

_Maine Molecular Quality Controls, Inc. · PMN · Nov 24, 2017 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K173171

## Device Facts

- **Applicant:** Maine Molecular Quality Controls, Inc.
- **Product Code:** [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN.md)
- **Decision Date:** Nov 24, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3920
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## 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, 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.

## Regulatory 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](/device/K161573.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K173171

B. Purpose for Submission:
To obtain a substantial equivalence determination for the FilmArray RP2/RP2plus Control Panel, P/N M315

C. Measurand:
Multi-analyte quality control materials

D. Type of Test:
FilmArray RP2/RP2plus Control Panel is intended for *in vitro* diagnostic use as external assayed quality control materials to monitor the qualitative amplification, detection and identification steps of the laboratory nucleic acid test, FilmArray RP2/RP2plus assay on the FilmArray 2.0 instrument or FilmArray Torch system, which detects respiratory pathogens: 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*.

E. Applicant:
Maine Molecular Quality Controls, Inc. (MMQCI)

F. Proprietary and Established Names:
FilmArray RP2/RP2plus Control Panel, P/N M315

G. Regulatory Information:
1. Regulation section:
21 CFR 866.3920, Assayed quality control material for clinical microbiology assays
2. Classification:
Class II (Special Controls)

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3. Product code:
PMN

4. Panel:
83- Microbiology

H. Indication(s) for use:

1. Indications for use(s):
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 internal controls provided with the test system.

2. Special conditions for use statement(s):
For in vitro diagnostic use only
For prescription use only

3. Special instrument requirements:
FilmArray RP2/RP2plus Control Panel was evaluated on FilmArray 2.0 instrument.

I. Device Description:
FilmArray RP2/RP2plus Control Panel is a quality control panel consisting of two controls: FilmArray RP2/RP2plus Positive Control and FilmArray RP2/RP2plus Negative Control. The Positive Control contains non-infectious 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 (see Table 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

2

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(nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

The FilmArray RP2/RP2plus Positive Control is prepared nucleic acid concentrations of 5X-10X LoD for each of the organisms detected by the FilmArray RP2/RP2plus assay.

|  Respiratory pathogens detected by FilmArray RP2 and RP2plus assay  |   |
| --- | --- |
|  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*  |   |

*Detected by FilmArray RP2plus assay only.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

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

2. Predicate 510(k) number(s):

K161573

3. Comparison with predicate:

There are no differences between the intended uses of the predicate (K161573) and the new device which raise new questions of safety and effectiveness.

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | FilmArray RP2/RP2plus Control Panel M315 | FilmArray RP EZ Control Panel M265 (K161573)  |
|  **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, 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 internal controls provided with the test system. | FilmArray RP EZ Control Panel M265 is intended for use as external positive and negative, surrogate assayed quality control materials 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 pneumonia on the FilmArray RP EZ assay performed on the FilmArray systems. The control panel also contains a negative control. This product is not intended to replace manufacturer controls provided with the device.  |
|  **Format** | Ready-to-Use Liquid | Same  |
|  **Directions for Use** | Process like patient sample Same | Same  |
|  **Composition** | Synthetic RNA transcripts | Same  |
|  **Assay Steps Monitored** | Reverse transcription, amplification, detection, identification | Same  |
|  **Number of Targets** | Multiple | Same  |

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K. Standard/Guidance Document Referenced (if applicable):

None were referenced

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Reproducibility:

A multi-site reproducibility study was performed with the FilmArray RP2/RP2plus Control Panel on FilmArray instrument 2.0. Testing consisted of three positive and three negative controls run per day, and spanned a period of 10 days (total of 60 control runs per site). Multiple operators participated in testing at each of the three locations. Three lots each of external control material and three lots of FilmArray RP2 pouches were tested across all sites. A total of 180 external controls were tested (90 positive and 90 negative). The results are shown in the tables below:

|  FilmArray RP2/RP2plus Control Panel Summary of External Reproducibility Test Results  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Category | SITE |   |   |   |   |   | All Sites | All Sites  |
|   |  Site #1 |   | Site #2 |   | Site #3 |   | Overall Percent Agreement | 95% Confidence Interval  |
|   |  #expected results/# tested¹ | % Agreement with Expected Result¹ | #expected results/# tested | % Agreement with Expected Result¹ | #expected results/# tested | % Agreement with Expected Result¹  |   |   |
|  FilmArray RP2/RP2 plus Positive Control | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 100% 90/90 | 95.9% to 100%  |
|  FilmArray RP2/RP2 plus Negative Control | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 100% 90/90 | 95.9% to 100%  |

¹ Expected result for the FilmArray RP2/RP2plus Positive Control is positive. Expected result for the FilmArray RP2/RP2plus Negative Control is negative

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|  Crossing Point (Cp) Data for FilmArray RP2/RP2plus Panel External Reproducibility Study  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Respiratory Pathogen Analyte | Site 1 |   | Site 2 |   | Site 3 |   | All External Sites  |   |
|   |  Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | Ave Cp | SD  |
|  Adeno2 | 19.9 | 2.0 | 18.8 | 2.0 | 19.5 | 1.6 | 19.4 | 1.9  |
|  Adeno3 | 17.5 | 1.5 | 17.5 | 1.9 | 18.4 | 1.3 | 17.8 | 1.6  |
|  Adeno6 | 15.4 | 1.7 | 15.2 | 1.6 | 16.0 | 1.4 | 15.6 | 1.6  |
|  Adeno7.1 | 16.1 | 1.9 | 15.9 | 1.4 | 16.0 | 1.9 | 16.0 | 1.7  |
|  Adeno8 | 13.8 | 1.4 | 13.9 | 1.2 | 14.0 | 1.2 | 13.9 | 1.3  |
|  IS1001 | 18.1 | 1.2 | 18.2 | 1.4 | 18.6 | 0.9 | 18.3 | 1.2  |
|  ptxP | 14.6 | 1.4 | 14.6 | 1.4 | 15.2 | 1.2 | 14.8 | 1.4  |
|  Cpne | 15.6 | 0.9 | 15.7 | 1.1 | 15.5 | 0.7 | 15.6 | 0.9  |
|  CoV-229E | 16.1 | 1.2 | 16.2 | 1.1 | 16.1 | 0.9 | 16.1 | 1.0  |
|  CoV-HKU1 | 17.6 | 1.3 | 17.6 | 1.2 | 17.8 | 1.0 | 17.6 | 1.2  |
|  CoV-NL63 | 17.3 | 2.2 | 17.2 | 1.3 | 17.1 | 1.4 | 17.2 | 1.7  |
|  CoV-OC43-2 | 19.6 | 2.6 | 19.1 | 1.5 | 19.1 | 1.9 | 19.2 | 2.0  |
|  CoV-OC43 | 16.3 | 0.9 | 16.5 | 1.0 | 16.5 | 0.9 | 16.4 | 1.0  |
|  hMPV | 17.7 | 2.5 | 16.7 | 1.6 | 16.8 | 2.1 | 17.1 | 2.1  |
|  HRV/EV | 16.4 | 0.8 | 16.4 | 1.1 | 16.6 | 0.8 | 16.5 | 0.9  |
|  FluA-H1-2 | 19.3 | 1.8 | 19.1 | 1.1 | 19.2 | 1.7 | 19.2 | 1.5  |
|  FluA-H1-2009 | 19.0 | 1.2 | 18.8 | 1.3 | 19.2 | 1.5 | 19.0 | 1.4  |
|  FluA-H3 | 16.0 | 0.7 | 16.0 | 1.4 | 16.1 | 0.6 | 16.0 | 1.0  |
|  FluA-pan1 | 15.3 | 0.8 | 15.5 | 1.1 | 15.4 | 0.6 | 15.4 | 0.9  |
|  FluA-pan2 | 16.8 | 1.9 | 16.5 | 1.2 | 16.3 | 1.4 | 16.5 | 1.5  |
|  FluB | 15.8 | 1.1 | 15.9 | 1.1 | 15.7 | 0.7 | 15.8 | 1.0  |
|  MERS1 | 19.2 | 2.2 | 18.9 | 1.4 | 19.3 | 1.8 | 19.1 | 1.8  |
|  MERS2 | 17.2 | 1.4 | 17.3 | 1.4 | 17.6 | 1.0 | 17.4 | 1.3  |
|  Mpne | 16.5 | 1.6 | 16.5 | 1.2 | 16.5 | 1.3 | 16.5 | 1.4  |
|  PIV1 | 16.4 | 2.6 | 15.7 | 1.6 | 15.8 | 1.6 | 16.0 | 2.0  |
|  PIV2 | 19.2 | 1.8 | 19.0 | 1.3 | 19.1 | 1.7 | 19.1 | 1.6  |
|  PIV3 | 17.6 | 1.3 | 17.5 | 1.1 | 17.4 | 1.1 | 17.5 | 1.2  |
|  PIV4 | 19.1 | 1.6 | 18.7 | 1.3 | 18.8 | 1.3 | 18.9 | 1.4  |
|  RSV | 15.4 | 1.2 | 15.4 | 1.0 | 15.3 | 0.8 | 15.4 | 1.0  |

The results suggest that there are no significant differences between different users and different sites on different days. External reproducibility studies for the FilmArray RP2/RP2plus Panel are acceptable.

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b. Precision:

An internal precision study for the FilmArray RP2/RP2plus was conducted over twenty days by testing three FilmArray RP2/RP2plus Control Panel lots with four FilmArray RP2/RP2plus assay lots performed by four operators using two FilmArray 2.0 instruments. The results are shown in the table below:

|  FilmArray RP2/RP2plus Control Panel Summary of Internal Precision Test Results  |   |   |   |
| --- | --- | --- | --- |
|  Category | #expected results/#tested^{1} | Overall Percent Agreement | 95% Confidence Interval  |
|  FilmArray RP2/RP2plus Positive Control | 60/60 | 100% | 94% to 100%  |
|  FilmArray RP2/RP2plus Negative Control | 60/61 | 98.4% | 91.3% to 99.7%  |

Expected result for the FilmArray RP2/RP2plus Positive Control is positive. Expected result for the FilmArray RP2/RP2plus Negative Control is negative.

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|  Crossing Point (Cp) data for FilmArray RP2/RP2plus Control Panel Internal Precision Study  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Respiratory Pathogen Analyte | C11MAY17 |   | G12JUN17 |   | B21JUN17 |   | All Lots | All Lots | All Lots  |
|   |  Mean Cp | SD | Mean Cp | SD | Mean Cp | SD | Mean Cp | SD | %CV  |
|  Adeno2 | 19.0 | 1.4 | 19.2 | 1.2 | 18.9 | 1.4 | 18.9 | 1.3 | 7.0%  |
|  Adeno3 | 17.1 | 1.5 | 17.6 | 1.5 | 17.6 | 1.3 | 17.5 | 1.5 | 8.4%  |
|  Adeno6 | 15.1 | 1.3 | 15.4 | 1.4 | 15.5 | 1.2 | 15.4 | 1.4 | 8.8%  |
|  Adeno7.1 | 15.5 | 1.3 | 15.5 | 1.3 | 16.0 | 1.1 | 15.7 | 1.3 | 8.3%  |
|  Adeno8 | 13.5 | 0.8 | 13.7 | 1.1 | 14.1 | 0.8 | 13.8 | 0.9 | 6.7%  |
|  IS1001 | 18.1 | 1.0 | 18.3 | 1.0 | 18.2 | 1.0 | 18.2 | 1.0 | 5.5%  |
|  ptxP | 14.5 | 1.1 | 15.0 | 1.1 | 15.0 | 1.0 | 14.9 | 1.1 | 7.5%  |
|  Cpne | 15.3 | 0.5 | 15.4 | 0.6 | 15.2 | 0.5 | 15.3 | 0.5 | 3.4%  |
|  CoV-229E | 16.3 | 0.8 | 16.7 | 1.0 | 16.5 | 0.7 | 16.6 | 0.8 | 5.1%  |
|  CoV-HKU1 | 17.5 | 0.6 | 17.5 | 0.8 | 17.7 | 0.6 | 17.6 | 0.7 | 3.9%  |
|  CoV-NL63 | 17.0 | 0.9 | 17.1 | 1.0 | 17.2 | 0.8 | 17.1 | 0.9 | 5.1%  |
|  CoV-OC43-2 | 20.3 | 1.5 | 20.5 | 1.4 | 20.9 | 1.2 | 20.8 | 1.2 | 6.0%  |
|  CoV-OC43 | 16.1 | 1.0 | 16.4 | 1.3 | 16.4 | 1.0 | 16.3 | 1.1 | 6.9%  |
|  hMPV | 17.4 | 1.3 | 17.5 | 1.4 | 17.9 | 1.0 | 17.7 | 1.3 | 7.2%  |
|  HRV/EV | 16.5 | 0.7 | 16.7 | 1.1 | 16.7 | 0.8 | 16.7 | 0.9 | 5.3%  |
|  FluA-H1-2 | 19.3 | 1.1 | 19.5 | 1.2 | 19.9 | 0.8 | 19.7 | 1.1 | 5.5%  |
|  FluA-H1-2009 | 18.8 | 0.8 | 18.7 | 1.3 | 18.8 | 0.8 | 18.8 | 1.0 | 5.3%  |
|  FluA-H3 | 15.7 | 0.4 | 15.5 | 0.7 | 15.5 | 0.6 | 15.5 | 0.6 | 3.8%  |
|  FluA-pan1 | 15.2 | 0.5 | 15.5 | 0.7 | 15.3 | 0.6 | 15.4 | 0.6 | 3.8%  |
|  FluA-pan2 | 16.5 | 1.1 | 16.7 | 1.0 | 17.0 | 0.8 | 16.8 | 1.0 | 5.9%  |
|  FluB | 15.6 | 0.5 | 15.4 | 0.6 | 15.6 | 0.5 | 15.5 | 0.5 | 3.3%  |
|  MERS1 | 19.5 | 1.1 | 19.8 | 1.3 | 19.8 | 0.9 | 19.9 | 1.1 | 5.3%  |
|  MERS2 | 17.5 | 0.9 | 17.9 | 1.1 | 17.6 | 0.9 | 17.8 | 1.0 | 5.4%  |
|  Mpne | 16.1 | 0.9 | 16.0 | 1.0 | 16.0 | 0.9 | 16.0 | 0.9 | 5.7%  |
|  PIV1 | 15.8 | 1.4 | 15.7 | 1.4 | 16.0 | 1.5 | 15.8 | 1.4 | 9.1%  |
|  PIV2 | 18.4 | 1.2 | 18.0 | 1.2 | 18.3 | 1.1 | 18.2 | 1.2 | 6.5%  |
|  PIV3 | 17.3 | 0.7 | 17.2 | 0.8 | 17.3 | 0.6 | 17.3 | 0.7 | 4.2%  |
|  PIV4 | 18.1 | 0.7 | 17.9 | 0.8 | 17.9 | 0.6 | 17.9 | 0.7 | 3.9%  |
|  RSV | 15.4 | 0.6 | 15.3 | 0.7 | 15.5 | 0.5 | 15.5 | 0.6 | 3.9%  |
|  Bper | 18.8 | 0.6 | 19.2 | 0.3 | 19.2 | 0.3 | 19.2 | 0.4 | 7.0%  |
|  Cpne | 16.0 | 1.8 | 15.6 | 1.9 | 15.9 | 1.9 | 15.7 | 1.9 | 8.4%  |
|  Mpne | 19.0 | 1.4 | 19.2 | 1.2 | 18.9 | 1.4 | 18.9 | 1.3 | 8.8%  |

There appears to be no significant differences in mean Cp value when testing different control lots on different days. Precision studies are acceptable.

c. Within-run Testing:

Within-run reproducibility was demonstrated in a separate study conducted by one operator testing one lots of FilmArray RP2/RP2plus with one lot of FilmArray RP2 pouches on the FilmArray 2.0, each within one day. The results are shown in the tables below:

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9

|  FilmArray RP2/RP2plus Control Panel Summary of Within-run Reproducibility Results  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Control | Control Lot# | No. of Tests | Pouch Lot | Correct Results  |
|  FilmArray RP2/RP2plus Positive Control | G12JUN17A | 6 | 606817 | 6/6 (100%)  |
|  FilmArray RP2/RP2plus Negative Control | F12JUN17A | 6 | 606817 | 6/6 (100%)  |
|  Crossing Point (Cp) data for FilmArray RP2/RP2plus Control Panel Within-run Reproducibility  |   |   |
| --- | --- | --- |
|  Respiratory Pathogen Analyte | FilmArray RP2/RP2plus Positive (Lot G12JUN17A)  |   |
|   |  Mean Cp | SD  |
|  Adeno2 | 19.4 | 1.5  |
|  Adeno3 | 16.5 | 1.2  |
|  Adeno6 | 14.1 | 1.1  |
|  Adeno7.1 | 14.4 | 1.2  |
|  Adeno8 | 13.1 | 0.9  |
|  IS1001 | 17.7 | 0.9  |
|  ptxP | 14.2 | 0.8  |
|  Cpne | 15.3 | 0.5  |
|  CoV-229E | 16.7 | 0.7  |
|  CoV-HKU1 | 17.3 | 0.8  |
|  CoV-NL63 | 16.4 | 0.9  |
|  CoV-OC43-2 | 20.0 | 1.8  |
|  CoV-OC43 | 16.1 | 0.5  |
|  hMPV | 16.6 | 1.3  |
|  HRV/EV | 16.4 | 0.7  |
|  FluA-H1-2 | 18.7 | 1.1  |
|  FluA-H1-2009 | 18.4 | 1.2  |
|  FluA-H3 | 15.4 | 0.6  |
|  FluA-pan1 | 15.5 | 0.5  |
|  FluA-pan2 | 15.8 | 0.8  |
|  FluB | 15.1 | 0.4  |
|  MERS1 | 19.4 | 1.4  |
|  MERS2 | 17.8 | 1.1  |
|  Mpne | 15.2 | 0.8  |
|  PIV1 | 14.5 | 1.2  |
|  PIV2 | 16.9 | 0.9  |
|  PIV3 | 16.9 | 0.7  |
|  PIV4 | 17.6 | 0.9  |

{9}

Within-run reproducibility studies for the FilmArray RP2/RP2plus Control Panel are acceptable.

## d. Lot-to-Lot Testing:

Lot-to-lot reproducibility was demonstrated by testing three lots of FilmArray RP2/RP2plus Positive Control using the same pouch lot. Results are shown in the following tables.

|  FilmArray RP2/RP2plus Control Panel Summary of Lot-to-Lot Reproducibility Results  |   |   |   |
| --- | --- | --- | --- |
|  Control Lot # | Number of Tests | Pouch Lot | Correct Results  |
|  C11MAY17A | 5 | 455917 | 5/5 (100%)  |
|  G12JUN17A | 5 | 455917 | 5/5 (100%)  |
|  B21JUN17A | 5 | 455917 | 5/5 (100%)  |
|  Crossing Point (Cp) data for FilmArray RP2/RP2plus Control Panel Lot-to-Lot Reproducibility  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|  Respiratory Pathogen Analyte | C11MAY17A | G12JUN17A | B21JUN17A | All lots | All Lots  |
|   |  Mean Cp | Mean Cp | Mean Cp | Mean Cp | SD  |
|  Adeno2 | 18.3 | 18.7 | 18.7 | 18.6 | 0.2  |
|  Adeno3 | 18.0 | 17.8 | 18.0 | 17.9 | 0.1  |
|  Adeno6 | 16.0 | 15.7 | 16.1 | 16.0 | 0.2  |
|  Adeno7.1 | 16.4 | 16.2 | 17.0 | 16.5 | 0.4  |
|  Adeno8 | 13.7 | 13.7 | 14.2 | 13.8 | 0.3  |
|  IS1001 | 18.4 | 18.2 | 18.2 | 18.3 | 0.1  |
|  ptxP | 14.9 | 14.9 | 15.0 | 14.9 | 0.1  |
|  Cpne | 15.3 | 15.2 | 15.2 | 15.2 | 0.0  |
|  CoV-229E | 16.0 | 16.2 | 16.1 | 16.1 | 0.1  |
|  CoV-HKU1 | 17.4 | 17.2 | 17.5 | 17.4 | 0.2  |
|  CoV-NL63 | 17.6 | 17.4 | 17.7 | 17.5 | 0.1  |
|  CoV-OC43-2 | 21.0 | 20.7 | 21.4 | 21.0 | 0.3  |
|  CoV-OC43 | 15.5 | 15.5 | 15.8 | 15.6 | 0.2  |
|  hMPV | 18.1 | 17.8 | 18.6 | 18.1 | 0.4  |
|  HRV/EV | 16.2 | 16.1 | 16.2 | 16.2 | 0.1  |
|  FluA-H1-2 | 19.8 | 19.7 | 20.2 | 19.9 | 0.3  |
|  FluA-H1-2009 | 18.3 | 18.1 | 18.4 | 18.3 | 0.2  |
|  FluA-H3 | 15.4 | 15.2 | 15.3 | 15.3 | 0.1  |
|  FluA-pan1 | 15.1 | 15.1 | 15.1 | 15.1 | 0.0  |
|  FluA-pan2 | 17.3 | 17.1 | 17.6 | 17.3 | 0.2  |

{10}

|  FluB | 15.7 | 15.5 | 15.7 | 15.6 | 0.1  |
| --- | --- | --- | --- | --- | --- |
|  MERS1 | 19.8 | 19.7 | 20.0 | 19.8 | 0.2  |
|  MERS2 | 17.5 | 17.4 | 17.5 | 17.5 | 0.1  |
|  Mpne | 16.8 | 16.7 | 16.9 | 16.8 | 0.1  |
|  PIV1 | 17.1 | 16.9 | 17.8 | 17.3 | 0.4  |
|  PIV2 | 19.4 | 19.0 | 19.5 | 19.3 | 0.3  |
|  PIV3 | 17.2 | 17.0 | 17.3 | 17.2 | 0.2  |
|  PIV4 | 17.9 | 17.9 | 18.0 | 17.9 | 0.1  |
|  RSV | 15.5 | 15.2 | 15.6 | 15.4 | 0.2  |

Lot-to-Lot reproducibility studies for the FilmArray RP2/RP2plus Control Panel are acceptable.

e. Linearity/assay reportable range:

Not applicable

f. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

Not applicable

Stability:

Open Vial Stability: Not applicable because FilmArray RP2/RP2plus Control Panel is packaged for single use.

Closed Vial Real-time Stability: An accelerated stability study was performed to establish the shelf life stability claims for FilmArray RP2/RP2plus Control Panel. Based on this study, the FilmArray RP2/RP2plus Control Panel is expected to be stable until the expiration date (12 months) when stored frozen $(-20^{\circ}\mathrm{C}$ or colder) and unopened. This product is for single use.

Real-Time Stability Program: Real-time stability studies are ongoing to support product claims and to monitor potential assay modifications for which the FilmArray RP2/RP2plus Control Panel is indicated for use. Real-time stability study protocols and acceptance criteria were reviewed and found to be acceptable.

Shipping Stability: MMQCI ships the FilmArray RP2/RP2plus Control Panel on dry ice with overnight delivery, ensuring that the control material remains frozen upon receipt. The frozen control material is then to be stored at $-20^{\circ}\mathrm{C}$, as indicated in the FilmArray RP2/RP2plus Control Panel Package insert. A shipping study was performed to confirm the shipping process and to investigate the outcome of a

{11}

possible shipping delay and subsequent arrival with no dry ice. The study evaluated two (2) lots of the FilmArray RP2/RP2plus Positive Control placed in dry ice and was stored for two (2) days at ambient temperature then tested using the FilmArray RP2plus Assay. To simulate a shipping delay, two (2) lots of the FilmArray RP2/RP2plus Positive Control were stored for up to 5 days at ambient temperature and tested using the FilmArray RP2plus Assay.

The study demonstrated that the FilmArray RP2/RP2plus Positive Control is stable for two (2) days on dry ice in MMQCI's standard shipping box. FilmArray RP2/RP2plus Positive Control is stable after five (5) days at ambient temperatures of approximately  $19 - 21^{\circ}\mathrm{C}$ . The FilmArray RP2/RP2plus Positive Control should be stored frozen  $(-20^{\circ}\mathrm{C}$  or colder) as indicated in the package insert.

# Expected Values:

FilmArray RP2/RP2plus Control Panel is a qualitative control and the expected results are listed in the tables below.

|  FilmArray RP2/RP2plus Positive Control FilmArray Result Summary  |   |
| --- | --- |
|  Viruses  |   |
|  Detected | Adenovirus  |
|  Detected | Coronavirus 229E  |
|  Detected | Coronavirus HKU1  |
|  Detected | Coronavirus NL63  |
|  Detected | Coronavirus OC43  |
|  Detected | Human Metapneumovirus  |
|  Detected | Human Rhinovirus/ Enterovirus  |
|  Detected | Influenza A H1-2009  |
|  Detected | Influenza A H3  |
|  Detected | Influenza B  |
|  Detected | Middle East Respiratory Syndrome*  |
|  Detected | Parainfluenza Virus 1  |
|  Detected | Parainfluenza Virus 2  |
|  Detected | Parainfluenza Virus 3  |
|  Detected | Parainfluenza Virus 4  |
|  Detected | Respiratory Syncytial Virus  |
|  Bacteria  |   |
|  Detected | Bordetella parapertussis (IS1001)  |
|  Detected | Bordetella pertussis (ptxP)  |
|  Detected | Chlamydia pneumoniae  |
|  Detected | Mycoplasma pneumoniae  |

* Middle East Respiratory Syndrome Coronavirus is reported on RP2plus only

{12}

|  FilmArray RP2/RP2plus Negative Control FilmArray Result Summary  |   |
| --- | --- |
|  Viruses  |   |
|  Not Detected | Adenovirus  |
|  Not Detected | Coronavirus 229E  |
|  Not Detected | Coronavirus HKU1  |
|  Not Detected | Coronavirus NL63  |
|  Not Detected | Coronavirus OC43  |
|  Not Detected | Human Metapneumovirus  |
|  Not Detected | Human Rhinovirus/ Enterovirus  |
|  Not Detected | Influenza A H1-2009  |
|  Not Detected | Influenza A H3  |
|  Not Detected | Influenza B  |
|  Not Detected | Middle East Respiratory Syndrome*  |
|  Not Detected | Parainfluenza Virus 1  |
|  Not Detected | Parainfluenza Virus 2  |
|  Not Detected | Parainfluenza Virus 3  |
|  Not Detected | Parainfluenza Virus 4  |
|  Not Detected | Respiratory Syncytial Virus  |
|  Bacteria  |   |
|  Not Detected | Bordetella parapertussis (IS1001)  |
|  Not Detected | Bordetella pertussis (ptxP)  |
|  Not Detected | Chlamydia pneumoniae  |
|  Not Detected | Mycoplasma pneumoniae  |

* Middle East Respiratory Syndrome Coronavirus is reported on RP2plus only

# Matrix Effects:

A study was performed to evaluate the effect of the FilmArray RP2/RP2plus Control Panel in the presence of viral transport media (VTM). Equal volumes of the same concentration of inactivated Influenza A H1N1-2009 were spiked into  $370\mu \mathrm{L}$  of VTM as well as  $370\mu \mathrm{L}$  of FilmArray RP2/RP2plus Negative Control, which contains the identical matrix found in the FilmArray RP2/RP2plus Positive Control. Both sample types of the H1N1-2009 were tested in triplicate by the FilmArray RP2plus assay.

Results demonstrated that samples prepared with FilmArray RP2/RP2plus Control Panel matrix generate equivalent results to samples prepared with VTM. Study results are shown in the table below:

{13}

|  Respiratory Pathogen Analyte | Spiked BEI H1N1-2009 Crossing Point (Cp)  |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  VTM |   |   | Mean Cp | MMQCI Matrix |   |   | Mean Cp  |
|  FluA-H1-2009 | 17.7 | 19.1 | 18.3 | 18.4 | 16.9 | 18.7 | 17.9 | 17.8  |
|  FluA-pan1 | 12.8 | 13.5 | 12.9 | 13.1 | 12.0 | 12.2 | 12.3 | 12.2  |
|  FluA-pan2 | 19.1 | 19.9 | 19.8 | 19.6 | 19.0 | 19.3 | 19.7 | 19.3  |

g. Detection limit:

Not applicable

h. Analytical Reactivity (Inclusivity):

Not applicable

i. Cross Reactivity:

Not applicable

j. Interference:

Not applicable

k. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

{14}

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable.

4. Clinical cut-off:

Not Applicable.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809 and the specials controls for this device type.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

15

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K173171](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K173171)

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