FilmArray RP EZ Control Panel M265

K161573 · Maine Molecular Quality Controls, Inc. · PMN · Sep 2, 2016 · Microbiology

Device Facts

• Record ID: K161573
• Device Name: FilmArray RP EZ Control Panel M265
• Applicant: Maine Molecular Quality Controls, Inc.
• Product Code: PMN · Microbiology
• Decision Date: Sep 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Indications for Use

FilmArray RP EZ Control Panel M265 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/ Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B, Parainfluenza Virus, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae on the FilmArray RP EZ assay performed on the FilmArray systems. FilmArray RP Positive Control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the FilmArray RP EZ assay. This product is not intended to replace manufacturer controls provided with the device.

Device Story

FilmArray RP EZ Control Panel M265 provides external positive and negative quality control materials for the FilmArray RP EZ assay. Positive control consists of synthetic RNA transcripts representing all respiratory pathogens detected by the assay; negative control consists of non-specific RNA in buffer. Controls are processed by laboratory personnel identically to patient nasopharyngeal swab samples in Viral Transport Media. The device is used on the FilmArray 2.0 instrument to monitor qualitative amplification, detection, and identification steps. Results are reviewed by clinicians to verify assay performance and ensure validity of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Reproducibility study (3 sites, 182 controls) showed 100% agreement for positive controls and 97.78% for negative controls. Internal precision and lot-to-lot studies confirmed consistent performance across operators, lots, and days, with stable Crossing Point (Cp) values.

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. Designed for use with FilmArray 2.0 EZ Configuration system. Monitors extraction, reverse transcription, amplification, detection, and identification steps.

Indications for Use

Indicated for use as external positive and negative quality control material for in vitro nucleic acid testing of respiratory pathogens (Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A/B, Parainfluenza, RSV, B. pertussis, C. pneumoniae, M. pneumoniae) using the FilmArray RP EZ assay. Intended for clinical laboratory use.

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

• Amplichek II (DEN150058)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K161573

B. Purpose for Submission:
To obtain a substantial equivalence determination for the FilmArray RP EZ Control Panel M265.

C. Measurand:
Multi-analyte quality control materials

D. Type of Test:
FilmArray RP EZ Control Panel M265 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 RP EZ assay on the FilmArray 2.0 instrument, which detects respiratory pathogens: 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*.

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

F. Proprietary and Established Names:
FilmArray RP EZ Control Panel M265

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 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.

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

3. Special instrument requirements:
The FilmArray RP EZ Control Panel M265 was evaluated on FilmArray 2.0 instrument.

I. Device Description:
FilmArray RP EZ Control Panel M265 is a quality control panel consisting of two controls: FilmArray RP EZ Positive Control and FilmArray RP EZ Negative Control. The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA in buffers, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the FilmArray RP EZ assay (see Table below) on the FilmArray instrument 2.0 EZ Configuration system. The RNA in the Negative Control is non-specific RNA in buffers, stabilizers and preservatives. Each liquid control of FilmArray RP EZ Control Panel M265 is processed separately according to FilmArray RP EZ assay manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

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The FilmArray RP EZ Positive Control M265 is prepared nucleic acid concentrations of 3X-10X LoD for each of the organisms detected by the FilmArray RP EZ assay.

| Respiratory pathogens detected by FilmArray RP EZ assay | |
| --- | --- |
| Adenovirus | Influenza A H1-2009 |
| Coronavirus | Influenza B |
| Human Metapneumovirus | Parainfluenza Virus |
| Human Rhinovirus/ Enterovirus | Respiratory Syncytial Virus |
| Influenza A | Bordetella pertussis |
| Influenza A subtype H1 | Chlamydophila pneumoniae |
| Influenza A subtype H3 | Mycoplasma pneumoniae |

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Amplichek II, Bio-Rad Laboratories

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

DEN150058

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | FilmArray RP EZ Control Panel M265 (K161573) | Amplichek II (DEN150058) |

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| Intended Use | 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. | Amplichek II is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. This product is only for use with assays and instruments listed in the Representative Results Chart in this labeling. |
| --- | --- | --- |
| Similarities | | |
| --- | --- | --- |
| Item | FilmArray RP EZ Control Panel M265 | Amplichek II (DEN150058) |
| Directions for Use | Process like patient sample Same | Same |
| Number of targets monitored in one assay | Multiplex | Same |
| Differences | | |
| --- | --- | --- |
| Item | FilmArray RP EZ Control Panel M265 (K161573) | Amplichek II (DEN150058) |
| Composition | Synthetic RNA | Intact microorganisms |
| Assay Steps Monitored | Same except does not monitor extraction | Extraction, reverse transcription, amplification, detection, identification |

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

None were referenced

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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 RP EZ Control Panel M265 on FilmArray instrument 2.0 EZ Configuration system at two CLIA-waived clinical sites and one simulated CLIA-waived test site (e.g., testing was performed at a laboratory with users that were screened to have training and educational backgrounds consistent with those in the CLIA-waived testing environment). 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 RP EZ pouches were tested across all sites. A total of 182 external controls were tested (91 positive and 91 negative). Two tests were excluded from the final data analysis due to Invalid results caused by internal pouch control failures. The results are shown in the tables below:

| FilmArray RP EZ 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 RP EZ Positive Control | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 100% 90/90 | 95.9% to 100% |
| FilmArray RP EZ Negative Control | 30/30 | 100% | 30/30 | 100% | 28/303 | 93.3% | 97.78% 88/90 | 92.3% to 99.4% |

1 Expected result for the FilmArray RP EZ Positive Control is positive. Expected result for the FilmArray RP EZ Negative Control is negative.
2 The 2 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.
3 Two false positives were observed with the FilmArray RP EZ Negative Control at site #3. The detected organisms were 1) Coronavirus CoV-NL63, 2) Coronavirus CoV-229E. The FilmArray RP EZ assay only reports Coronavirus as Detected or Not Detected.

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| Crossing Point (Cp) data for FilmArray RP EZ Control Panel External Reproducibility Study | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Respiratory Pathogen Analyte | Site | | Site 2 | | Site | | All Sites | |
| | Mean Cp | SD | Mean Cp | SD | Mean Cp | SD | Mean Cp | SD |
| Adeno | 22.6 | 1.2 | 22.0 | 1.3 | 22.2 | 1.2 | 22.3 | 1.2 |
| Adeno2 | 21.0 | 1.1 | 20.6 | 1.2 | 20.7 | 1.0 | 20.8 | 1.1 |
| CoV-229E¹ | 20.9 | 0.7 | 20.5 | 1.1 | 20.5 | 0.8 | 20.6 | 0.9 |
| CoV-HKU1¹ | 19.8 | 1.1 | 19.3 | 1.1 | 19.4 | 0.8 | 19.5 | 1.0 |
| CoV-NL63¹ | 19.6 | 1.5 | 18.8 | 1.0 | 18.9 | 0.7 | 19.1 | 1.1 |
| CoV-OC43¹ | 19.4 | 0.8 | 19.0 | 1.2 | 18.9 | 0.6 | 19.1 | 0.9 |
| hMPV | 21.8 | 1.3 | 21.4 | 1.4 | 21.2 | 1.0 | 21.5 | 1.2 |
| Entero1 | 20.4 | 1.0 | 20.0 | 1.1 | 20.0 | 0.8 | 20.1 | 1.0 |
| Entero2 | 20.4 | 1.2 | 20.0 | 1.1 | 20.0 | 0.8 | 20.1 | 1.0 |
| HRV1 | 17.5 | 0.7 | 17.2 | 1.1 | 16.9 | 0.7 | 17.2 | 0.8 |
| HRV2 | 18.0 | 0.7 | 17.7 | 1.0 | 17.4 | 0.7 | 17.7 | 0.8 |
| HRV3 | 22.7 | 0.9 | 22.6 | 1.3 | 21.8 | 0.7 | 22.4 | 1.0 |
| HRV4 | 19.5 | 0.9 | 19.2 | 1.0 | 18.9 | 0.6 | 19.2 | 0.8 |
| FluA-H1-2009 | 18.7 | 1.2 | 18.2 | 1.1 | 18.2 | 0.8 | 18.4 | 1.0 |
| FluA-H1-pan | 18.8 | 1.1 | 18.3 | 1.1 | 18.4 | 0.8 | 18.5 | 1.0 |
| FluA-H3 | 18.1 | 0.8 | 17.7 | 1.2 | 17.6 | 0.9 | 17.8 | 1.0 |
| FluA-pan1 | 19.7 | 0.8 | 19.2 | 1.1 | 19.1 | 0.7 | 19.3 | 0.9 |
| FluA-pan2 | 20.0 | 1.0 | 19.5 | 1.1 | 19.5 | 0.6 | 19.7 | 0.9 |
| FluB | 19.3 | 0.7 | 18.9 | 1.2 | 18.7 | 0.7 | 19.0 | 0.9 |
| PIV1 | 20.5 | 1.4 | 19.7 | 1.3 | 19.9 | 0.9 | 20.0 | 1.2 |
| PIV2 | 20.1 | 0.9 | 19.8 | 1.1 | 19.6 | 0.6 | 19.8 | 0.9 |
| PIV3 | 18.8 | 0.9 | 18.4 | 1.1 | 18.2 | 0.6 | 18.5 | 1.1 |
| PIV4 | 19.2 | 1.2 | 18.6 | 1.3 | 18.5 | 0.8 | 18.8 | 1.1 |
| RSV | 18.8 | 0.8 | 18.4 | 1.2 | 18.1 | 0.7 | 18.4 | 0.9 |
| Bper | 20.9 | 0.8 | 20.5 | 1.0 | 20.5 | 0.7 | 20.6 | 0.8 |
| Cpne | 19.0 | 0.8 | 18.5 | 1.2 | 18.4 | 0.7 | 18.6 | 0.9 |
| Mpne | 19.5 | 1.2 | 18.7 | 1.2 | 18.6 | 0.7 | 18.9 | 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 RP EZ Control Panel M265 are acceptable.

## b. Precision:

An internal precision study for the FilmArray RP EZ Control Panel M265 was conducted over multiple days by testing three FilmArray RP EZ Control Panel lots with four FilmArray RP EZ assay lots performed by one operator. The results are shown in the table below:

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| FilmArray RP EZ Control Panel Summary of Internal Precision Test Results | | | | |
| --- | --- | --- | --- | --- |
| Category | Operator #1 | | Combined | |
| | #expected results/#tested¹ | % Agreement with Expected Result¹ | Overall Percent Agreement | 95% Confidence Interval |
| FilmArray RP EZ Positive Control | 39/39 | 100% | 100% | 91% to 100% |
| FilmArray RP EZ Negative Control | 49/49 | 100% | 100% | 92.7% to 100% |
| Crossing Point (Cp) data for FilmArray RP EZ Control Panel External Precision Study | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Respiratory Pathogen Analyte | Control Lot#: M40DEC15A | | Control Lot#: A28DEC15A | | Control Lot#: A06JAN16A | | All Lots | |
| | Mean Cp | SD | Mean Cp | SD | Mean Cp | SD | Mean Cp | SD |
| Adeno | 22.1 | 1.1 | 21.9 | 1.4 | 21.6 | 0.6 | 21.4 | 0.5 |
| Adeno2 | 20.2 | 0.7 | 19.9 | 1.1 | 19.7 | 0.4 | 19.5 | 0.3 |
| CoV-229E¹ | 19.7 | 0.6 | 19.5 | 0.6 | 19.4 | 0.5 | 19.2 | 0.1 |
| CoV-HKU1¹ | 18.5 | 0.7 | 18.4 | 0.6 | 18.2 | 0.4 | 18.0 | 0.2 |
| CoV-NL63¹ | 18.1 | 0.4 | 18.0 | 0.5 | 17.9 | 0.4 | 17.8 | 0.3 |
| CoV-OC43¹ | 18.1 | 0.3 | 17.9 | 0.5 | 17.9 | 0.4 | 17.8 | 0.4 |
| hMPV | 21.4 | 0.8 | 21.0 | 1.0 | 21.1 | 0.4 | 21.1 | 0.4 |
| Entero1 | 19.1 | 0.7 | 19.1 | 0.8 | 18.9 | 0.4 | 19.1 | 0.3 |
| Entero2 | 19.0 | 0.6 | 19.0 | 0.8 | 18.9 | 0.4 | 19.1 | 0.3 |
| HRV1 | 16.2 | 0.1 | 16.0 | 0.4 | 16.0 | 0.4 | 16.0 | 0.3 |
| HRV2 | 17.1 | 0.2 | 16.8 | 0.4 | 16.9 | 0.4 | 16.8 | 0.3 |
| HRV3 | 24.9 | 1.6 | 23.6 | 1.9 | 23.8 | 1.7 | 22.9 | 0.5 |
| HRV4 | 19.9 | 0.5 | 19.6 | 0.7 | 19.9 | 0.4 | 20.0 | 0.4 |
| FluA-H1-2009 | 17.2 | 0.6 | 17.1 | 0.6 | 16.8 | 0.4 | 16.6 | 0.3 |
| FluA-H1-pan | 18.1 | 0.8 | 17.8 | 0.8 | 17.5 | 0.5 | 17.3 | 0.4 |
| FluA-H3 | 17.6 | 0.5 | 17.2 | 0.6 | 17.3 | 0.3 | 17.2 | 0.3 |
| FluA-pan1 | 18.5 | 0.4 | 18.2 | 0.4 | 18.4 | 0.4 | 18.5 | 0.4 |
| FluA-pan2 | 19.0 | 0.5 | 18.7 | 0.4 | 18.6 | 0.3 | 18.5 | 0.3 |
| FluB | 18.1 | 0.4 | 17.9 | 0.4 | 17.8 | 0.5 | 17.6 | 0.4 |
| PIV1 | 18.8 | 0.7 | 18.8 | 0.8 | 18.3 | 0.3 | 18.2 | 0.3 |
| PIV2 | 19.0 | 0.3 | 18.8 | 0.4 | 18.8 | 0.6 | 18.4 | 0.4 |
| PIV3 | 17.9 | 0.5 | 17.4 | 0.5 | 17.6 | 0.4 | 17.5 | 0.4 |
| PIV4 | 19.2 | 0.7 | 18.7 | 0.9 | 18.9 | 0.5 | 18.9 | 0.7 |
| RSV | 17.6 | 0.2 | 17.4 | 0.5 | 17.5 | 0.4 | 17.4 | 0.4 |
| Bper | 19.9 | 0.4 | 19.7 | 0.8 | 19.7 | 0.4 | 19.6 | 0.4 |
| Cpne | 17.6 | 0.2 | 17.4 | 0.3 | 17.6 | 0.4 | 17.5 | 0.4 |
| Mpne | 17.8 | 0.2 | 17.6 | 0.4 | 17.7 | 0.5 | 17.6 | 0.4 |

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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 two lots of FilmArray RP EZ Control Panel M265 with one lot of FilmArray RP EZ pouches on the FilmArray 2.0, each within one day. The results are shown in the tables below:

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| FilmArray RP EZ Control Panel Summary of Within-run Reproducibility Results | | | | |
| --- | --- | --- | --- | --- |
| Control | Control Lot# | No. of Tests | Pouch Lot | Correct Results |
| FilmArray RP EZ Positive Control | A06JAN16A | 6 | 239115 | 6/6 (100%) |
| FilmArray RP EZ Negative Control | M41DEC15A | 5 | 239115 | 5/5 (100%) |
| Crossing Point (Cp) data for FilmArray RP EZ Control Panel Within-run Reproducibility | | |
| --- | --- | --- |
| Respiratory Pathogen Analyte | FilmArray RP EZ Positive Control (Lot A06JAN16A) | |
| | Mean Cp | SD |
| Adeno | 21.4 | 0.5 |
| Adeno2 | 19.5 | 0.3 |
| CoV-229E1 | 19.2 | 0.1 |
| CoV-HKU11 | 18.0 | 0.2 |
| CoV-NL631 | 17.8 | 0.3 |
| CoV-OC431 | 17.8 | 0.4 |
| hMPV | 21.1 | 0.4 |
| Entero1 | 19.1 | 0.3 |
| Entero2 | 19.1 | 0.3 |
| HRV1 | 16.0 | 0.3 |
| HRV2 | 16.8 | 0.3 |
| HRV3 | 22.9 | 0.5 |
| HRV4 | 20.0 | 0.4 |
| FluA-H1-2009 | 16.6 | 0.3 |
| FluA-H1-pan | 17.3 | 0.4 |
| FluA-H3 | 17.2 | 0.3 |
| FluA-pan1 | 18.5 | 0.4 |
| FluA-pan2 | 18.5 | 0.3 |
| FluB | 17.6 | 0.4 |
| PIV1 | 18.2 | 0.3 |
| PIV2 | 18.4 | 0.4 |
| PIV3 | 17.5 | 0.4 |
| PIV4 | 18.9 | 0.7 |
| RSV | 17.4 | 0.4 |
| Bper | 19.6 | 0.4 |
| Cpne | 17.5 | 0.4 |
| Mpne | 17.6 | 0.4 |

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Within-run reproducibility studies for the FilmArray RP EZ Control Panel M265 are acceptable.

# d. Lot-to-Lot Testing:

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

| FilmArray RP EZ Control Panel Summary of Lot-to-Lot Reproducibility Results | | | |
| --- | --- | --- | --- |
| Control Lot # | Number of Tests | Pouch Lot | Correct Results |
| M40DEC15A | 4 | 238915 | 4/4 (100%) |
| A28DEC15A | 3 | 238915 | 3/3 (100%) |
| A06JAN16A | 5 (1 Invalid) | 238915 | 4/4 (100%) |
| Crossing Point (Cp) data for FilmArray RP EZ Control Panel Lot-to-Lot Reproducibility | | | | | |
| --- | --- | --- | --- | --- | --- |
| Respiratory Pathogen Analyte | M40DEC15A | A28DEC15A | A06JAN16A | All Lots | All Lots |
| | Mean Cp | Mean Cp | Mean Cp | Mean Cp | SD |
| Adeno | 21.6 | 20.8 | 21.7 | 21.4 | 0.5 |
| Adeno2 | 19.8 | 18.8 | 19.7 | 19.5 | 0.6 |
| CoV-229E1 | 19.3 | 18.8 | 19.4 | 19.2 | 0.4 |
| CoV-HKU11 | 18.1 | 17.7 | 18.4 | 18.1 | 0.4 |
| CoV-NL631 | 18.1 | 17.7 | 18.1 | 18.0 | 0.4 |
| CoV-OC431 | 18.3 | 17.5 | 18.2 | 18.0 | 0.5 |
| hMPV | 21.1 | 20.1 | 20.8 | 20.7 | 0.6 |
| Entero1 | 18.4 | 18.0 | 18.5 | 18.3 | 0.4 |
| Entero2 | 18.4 | 18.0 | 18.5 | 18.3 | 0.4 |
| HRV1 | 16.2 | 15.8 | 16.2 | 16.1 | 0.4 |
| HRV2 | 17.1 | 16.6 | 17.2 | 17.0 | 0.4 |
| HRV3 | 25.6 | 24.2 | 25.3 | 25.1 | 1.9 |
| HRV4 | 19.6 | 18.9 | 19.6 | 19.4 | 0.5 |
| FluA-H1-2009 | 16.9 | 16.4 | 16.8 | 16.7 | 0.3 |
| FluA-H1-pan | 17.8 | 17.1 | 17.7 | 17.5 | 0.4 |
| FluA-H3 | 17.4 | 16.6 | 17.4 | 17.2 | 0.5 |
| FluA-pan1 | 18.5 | 17.8 | 18.4 | 18.3 | 0.4 |
| FluA-pan2 | 18.7 | 18.3 | 18.6 | 18.5 | 0.3 |
| FluB | 17.9 | 17.4 | 18.0 | 17.8 | 0.4 |
| PIV1 | 18.5 | 18.0 | 18.3 | 18.3 | 0.4 |
| PIV2 | 19.1 | 18.4 | 19.3 | 19.0 | 0.5 |
| PIV3 | 17.8 | 17.1 | 17.8 | 17.6 | 0.4 |
| PIV4 | 19.2 | 17.9 | 18.8 | 18.7 | 0.7 |
| RSV | 17.7 | 17.1 | 17.7 | 17.6 | 0.4 |
| Bper | 19.7 | 19.1 | 19.8 | 19.6 | 0.5 |
| Bper2 | 19.7 | 19.1 | 19.8 | 19.6 | 0.5 |
| Bper3 | 19.7 | 19.1 | 19.8 | 19.6 | 0.5 |
| Bper4 | 19.7 | 19.1 | 19.8 | 19.6 | 0.5 |

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| Crossing Point (Cp) data for FilmArray RP EZ Control Panel Lot-to-Lot Reproducibility | | | | | |
| --- | --- | --- | --- | --- | --- |
| Respiratory Pathogen Analyte | M40DEC15A | A28DEC15A | A06JAN16A | All Lots | All Lots |
| | Mean Cp | Mean Cp | Mean Cp | Mean Cp | SD |
| Cpne | 17.6 | 17.1 | 17.8 | 17.5 | 0.4 |
| Mpne | 17.9 | 17.3 | 18.0 | 17.8 | 0.5 |

Lot-to-Lot reproducibility studies for the FilmArray RP EZ Control Panel M265 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 RP EZ Control Panel M265 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 RP EZ Control Panel M265. Based on this study, the FilmArray RP EZ Control Panel M265 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 RP EZ Control Panel M265 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 RP EZ 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 RP EZ Control Panel Package insert. A shipping study was performed to confirm the shipping process and to investigate the outcome of a possible shipping delay and subsequent arrival with no dry ice. The study evaluated two (2) lots of the FilmArray RP EZ Positive Control placed in dry ice and was stored for two (2) days at ambient temperature then tested using the FilmArray RP EZ Assay. To simulate a shipping delay, two (2) lots of the FilmArray RP EZ Positive Control M266 were

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stored for up to 6 days at ambient temperature and tested using the FilmArray RP EZ Assay.

The study demonstrated that the FilmArray RP EZ Positive Control M265 is stable for two (2) days on dry ice in MMQCI's standard shipping box. FilmArray RP EZ Positive Control is stable after five (5) days at ambient temperatures of approximately $19 - 21^{\circ}\mathrm{C}$ . The FilmArray RP EZ Positive Control should be stored frozen $(-20^{\circ}\mathrm{C}$ or colder) as indicated in the package insert.

# Expected Values:

FilmArray RP EZ Control Panel M265 is a qualitative control and the expected results are listed in the tables below.

FilmArray RP EZ Positive Control FilmArray Result Summary

| Multiple Organisms Detected. Influenza A – Multiple Subtypes Detected | |
| --- | --- |
| Results Summary | |
| Detected | Not Detected |
| Adenovirus | |
| Coronavirus | |
| Human Metapneumovirus Human Rhinovirus | |
| Enterovirus | |
| Influenza A H1-2009 | |
| Influenza A H3 | |
| Influenza B Parainfluenza Virus | |
| Respiratory Syncytial Virus | |
| Bordetella pertussis | |
| Chlamydophila pneumoniae | |
| Mycoplasma pneumoniae | |

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FilmArray RP EZ Negative Control FilmArray Result Summary

| Negative | |
| --- | --- |
| Results Summary | |
| Detected | Not Detected |
| | Adenovirus
Coronavirus
Human Metapneumovirus
Human Rhinovirus
Enterovirus Influenza A
Influenza B
Parainfluenza Virus
Respiratory Syncytial Virus
Bordetella pertussis
Chlamydophila pneumoniae
Mycoplasma pneumoniae |

Matrix Effects:

A study was performed to evaluate the effect of the FilmArray RP EZ Control Panel M265 in the presence of viral transport media (VTM). Equal volumes of the same concentration of inactivated Influenza A H1N1-2009 were spiked into 300μL of VTM as well as 300μL of FilmArray RP EZ Negative Control, which contains the identical matrix found in the FilmArray RP EZ Positive Control. Both sample types of the H1N1-2009 were tested in triplicate by the FilmArray RP EZ assay.

Results demonstrated that samples prepared with FilmArray RP EZ Control Panel M265 matrix generate equivalent results to samples prepared with VTM. Study results are shown in the table below:

| Respiratory Pathogen Analyte | Spiked BEI H1N1-2009 Crossing Point (Cp) Data | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | VTM | | | Mean Cp | MMQCI Matrix | | | Mean Cp |
| FluA-H1-2009 | 16.9 | 17.2 | 17.2 | 17.1 | 17.4 | 16.3 | 16.5 | 16.7 |
| FluA-H1-pan | 18.1 | 18.5 | 18.2 | 18.3 | 18.7 | 17.5 | 17.4 | 17.8 |
| FluA-pan1 | 13.9 | 13.6 | 14.5 | 14.0 | 12.4 | 12.8 | 12.7 | 12.6 |
| FluA-pan2 | 19.1 | 19.3 | 19.6 | 19.4 | 18.9 | 18.2 | 18.6 | 18.5 |

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

4. Clinical cut-off:
Not Applicable.

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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.

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