← Product Code [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN) · K190222

# FilmArray Pneumonia/Pneumoniaplus Control (K190222)

_Maine Molecular Quality Controls, Inc. · PMN · May 3, 2019 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K190222

## Device Facts

- **Applicant:** Maine Molecular Quality Controls, Inc.
- **Product Code:** [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN.md)
- **Decision Date:** May 3, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3920
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

FilmArray Pneumonia/Pneumoniaplus Control 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 bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray® Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray® systems. FilmArray Pneumonia/Pneumoniaplus Control is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer controls provided with the device.

## Device Story

FilmArray Pneumonia/Pneumoniaplus Control is a quality control material consisting of a positive control (synthetic DNA/RNA in buffers/stabilizers) and a negative control (buffers/stabilizers). It is used in clinical laboratories to monitor the performance of FilmArray Pneumonia Panel and Pneumonia Panel plus assays. The user processes the liquid control samples similarly to patient sputum samples by loading them into the FilmArray pouch. The FilmArray system performs automated nucleic acid extraction, reverse transcription, PCR amplification, and detection. The control provides a known result to verify that the assay system is functioning correctly, including the detection of specific respiratory pathogens and antimicrobial resistance genes. This helps ensure the reliability of patient test results and aids in clinical decision-making by confirming the validity of the testing process.

## Clinical Evidence

No clinical data. Bench testing only. Reproducibility study (n=185) across three sites showed 96.8% agreement for positive controls and 97.8% for negative controls. Internal precision study (n=63) showed 95% agreement for positive controls and 100% for negative controls. Lot-to-lot reproducibility and shipping stability studies were also performed and found acceptable.

## Technological Characteristics

Ready-to-use liquid control panel. Positive control contains synthetic DNA and RNA transcripts in buffers, stabilizers, and preservatives. Negative control contains buffers, stabilizers, and preservatives. Single-use format. Designed for use with FilmArray 2.0 and Torch systems. Storage at -20°C or colder.

## 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.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
K190222

B. Purpose for Submission:
To obtain a substantial equivalence determination for the FilmArray Pneumonia/Pneumoniaplus Control, P/N M340

C. Measurand:
Multi-analyte quality control materials

D. Type of Test:
FilmArray Pneumonia/Pneumoniaplus Control 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 Pneumonia Panel/Pneumonia plus Panel on the FilmArray systems, which detects respiratory pathogens: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus.

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

F. Proprietary and Established Names:
FilmArray Pneumonia/Pneumoniaplus Control, P/N M340
FilmArray Pneumonia/Pneumoniaplus Control

G. Regulatory Information:
1. Regulation section:

{1}

21 CFR 866.3920, Assayed quality control material for clinical microbiology assays

2. Classification:
Class II (Special Controls)

3. Product code:
PMN

4. Panel:
83- Microbiology

H. Indication(s) for use:

1. Indications for use(s):
FilmArray Pneumonia/Pneumoniaplus Control 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 bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray systems. FilmArray Pneumonia/Pneumoniaplus Control is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. 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:
FilmArray Pneumonia/Pneumoniaplus Control Panel was evaluated on the FilmArray 2.0 instrument.

{2}

# I. Device Description:

FilmArray Pneumonia/Pneumoniaplus Control, P/N M340, is a quality control panel consisting of 2 controls, FilmArray Pneumonia/Pneumoniaplus Positive (Positive Control), P/N M34235, and FilmArray Pneumonia/Pneumoniaplus Negative, (Negative Control), P/N M34135. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA and RNA in buffers, stabilizers and preservatives. The DNA and RNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the respiratory pathogens and antimicrobial resistance genes detected and identified by the FilmArray Pneumonia Panel and Pneumonia Panel plus assays (see Table 1 below) on the FilmArray systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray Pneumonia/Pneumoniaplus Control is processed separately according to FilmArray Pneumonia Panel or Pneumonia Panel plus assays manufacturer's Instructions for Use for patient samples (Sputum) obtained from individuals suspected of lower respiratory tract infection. Each tube of control contains sufficient liquid for a single use.

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

Table 1. Respiratory pathogens and antimicrobial resistance genes detected by FilmArray Pneumonia Panel & Pneumonia Panel plus assays.

|  Bacteria  |   |
| --- | --- |
|  Acinetobacter calcoaceticus-baumannii complex | Pseudomonas aeruginosa  |
|  Enterobacter cloacae complex | Serratia marcescens  |
|  Escherichia coli | Staphylococcus aureus  |
|  Haemophilus influenzae | Streptococcus agalactiae  |
|  Klebsiella aerogenes | Streptococcus pneumoniae  |
|  Klebsiella oxytoca | Streptococcus pyogenes  |
|  Klebsiella pneumoniae group | Chlamydia pneumoniae  |
|  Moraxella catarrhalis | Legionella pneumophila  |
|  Proteus spp. | Mycoplasma pneumoniae  |
|  Antimicrobial Resistance Genes  |   |
|  CTX-M | NDM  |
|  IMP | OXA-48 like  |
|  KPC | VIM  |
|  mecA/C and MREJ |   |
|  Viruses  |   |
|  Adenovirus | Influenza B  |
|  Bacylglycerol | Pneumocystis jirovecii  |
|  Cytomegalovirus | Pneumocystis jirovecii  |
|  Diphtheria | Pneumocystis jirovecii  |
|  E. coli | Staphylococcus aureus  |
|  Flavobacterium | Streptococcus agalactiae  |
|  Flavobacterium | Streptococcus pyogenes  |
|  G. coli | Streptococcus pneumoniae  |
|  H. influenzae | Streptococcus pneumoniae  |
|  H. influenzae | Streptococcus pyogenes  |
|  I. coli | Streptococcus pneumoniae  |
|  K. pneumoniae | Streptococcus pneumoniae  |
|  L. pneumoniae | Streptococcus pneumoniae  |
|  M. pneumoniae | Streptococcus pneumoniae  |
|  O. pneumoniae | Streptococcus pneumoniae  |
|  P. pneumoniae | Streptococcus pneumoniae  |
|  R. pneumoniae | Streptococcus pneumoniae  |
|  S. pneumoniae | Streptococcus pneumoniae  |
|  T. pneumoniae | Streptococcus pneumoniae  |
|  V. pneumoniae | Streptococcus pneumoniae  |
|  W. pneumoniae | Streptococcus pneumoniae  |

{3}

*Detected by FilmArray Pneumonia Panel plus 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:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device: FilmArray Pneumonia/Pneumoniaplus Control (K173171) | Predicate: FilmArray RP EZ Control Panel M265 (K161573)  |
|  Intended Use | FilmArray Pneumonia/Pneumoniaplus Control 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 bacteria: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory | 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.  |

{4}

|  Similarities  |   |   |
| --- | --- | --- |
|   | Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus on the FilmArray Pneumonia Panel or Pneumonia Panel plus assays performed on FilmArray systems. FilmArray Pneumonia/Pneumoniaplus Control is composed of synthetic DNA and RNA specifically designed for and intended to be used solely with the FilmArray Pneumonia Panel and FilmArray Pneumonia Panel plus assays. This product is not intended to replace manufacturer controls provided with the device. |   |
|  Physical Format | Ready-to-Use Liquid | Same  |
|  Directions for Use | Process like patient sample | Same  |
|  Assay Steps Monitored | Reverse transcription, amplification, detection, identification | Same  |
|  Number of Targets | Multiple | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device: FilmArray Pneumonia/Pneumoniaplus Control (K173171) | Predicate: FilmArray RP EZ Control Panel M265 (K161573)  |
|  Targets | Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae; antimicrobial resistance genes: CTX-M, IMP, KPC, mecA/C and MREJ, NDM, OXA-48 like, VIM; and viruses: Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza B, Middle East Respiratory | 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  |

{5}

|  Differences  |   |   |
| --- | --- | --- |
|   | Syndrome Coronavirus (MERS-CoV), Parainfluenza Virus and Respiratory Syncytial Virus |   |
|  Composition | Synthetic RNA & DNA transcripts | Synthetic RNA transcripts  |

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 Pneumonia/Pneumoniaplus Control on FilmArray instrument 2.0 and FilmArray Torch systems. Testing consisted of three positive and three negative controls run per day and spanned a period of 10 days. Multiple operators participated in testing at each of the three locations. Three lots each of external control material and three lots of FilmArray Pneumonia/Pneumoniaplus pouch lots were tested across all sites. A total of 185 external controls were tested (93 positive and 92 negative). The results are shown in the Tables 2 below:

{6}

Table 2: FilmArray Pneumonia/Pneumoniaplus Control Reproducibility Study Summary

|  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 Positive Control | 30/30 | 100% | 30/32 | 93.8% | 30/31 | 96.8% | 96.8% 90/93 | 90.9% to 98.9%  |
|  FilmArray Negative Control | 30/31 | 96.8% | 30/31 | 96.8% | 30/30 | 100% | 97.8% 90/92 | 92.4% to 99.4%  |

Expected result for the FilmArray Pneumonia/Pneumoniaplus Positive Control is positive. Expected result for the FilmArray Pneumonia/Pneumoniaplus Negative Control is negative

Table 3: Reproducibility External Crossing Point (Cp) Summary

|  Analyte | Site 1 |   | Site 2 |   | Site 3 |   | All External Sites  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | %CV  |
|  Acinetobacter | 15.3 | 0.6 | 16.0 | 0.8 | 16.0 | 1.0 | 15.6 | 0.9 | 5.6%  |
|  Adenovirus 2 | 11.6 | 0.9 | 12.2 | 0.9 | 12.3 | 1.5 | 11.9 | 1.2 | 9.8%  |
|  Adenovirus 3 | 10.7 | 0.8 | 11.3 | 0.8 | 11.4 | 1.4 | 11.0 | 1.0 | 9.4%  |
|  Adenovirus 7 | 11.8 | 0.7 | 12.1 | 1.1 | 11.9 | 1.0 | 11.8 | 1.0 | 8.1%  |
|  C. pneumoniae | 12.4 | 0.6 | 12.2 | 0.6 | 12.6 | 0.7 | 12.3 | 0.6 | 5.3%  |
|  Coronavirus | 16.7 | 1.1 | 16.6 | 0.8 | 17.1 | 0.9 | 16.6 | 0.9 | 5.6%  |
|  CTX-M | 12.9 | 0.9 | 13.6 | 0.8 | 13.7 | 1.4 | 13.3 | 1.1 | 8.4%  |
|  E. coli | 12.3 | 0.6 | 12.7 | 0.9 | 12.8 | 1.2 | 12.6 | 0.9 | 7.5%  |
|  Enterobacter 1 | 13.4 | 0.8 | 14.0 | 1.0 | 14.1 | 1.4 | 13.7 | 1.1 | 8.2%  |
|  Enterobacter 2 | 13.0 | 0.8 | 13.6 | 1.0 | 13.6 | 1.2 | 13.3 | 1.0 | 7.8%  |
|  H. influenzae | 13.8 | 0.9 | 14.2 | 1.3 | 14.1 | 1.2 | 13.9 | 1.2 | 8.7%  |
|  K. oxytoca | 13.0 | 0.7 | 13.7 | 1.0 | 13.8 | 1.4 | 13.4 | 1.1 | 8.1%  |
|  K. pneumoniae | 15.2 | 0.8 | 15.8 | 0.9 | 15.9 | 1.3 | 15.5 | 1.0 | 6.7%  |
|  M. catarrhalis | 13.1 | 0.7 | 13.6 | 1.0 | 13.5 | 1.1 | 13.3 | 1.0 | 7.3%  |
|  P. aeruginosa | 14.8 | 0.8 | 15.5 | 0.9 | 15.6 | 1.5 | 15.1 | 1.2 | 7.7%  |
|  Proteus | 14.2 | 0.7 | 14.8 | 0.9 | 14.8 | 0.9 | 14.4 | 0.9 | 6.2%  |
|  S. marcescens | 15.0 | 0.6 | 15.4 | 0.9 | 15.4 | 1.0 | 15.1 | 0.9 | 5.8%  |
|  hMPV | 16.0 | 0.8 | 15.7 | 0.8 | 16.3 | 1.1 | 15.8 | 0.9 | 5.9%  |
|  HRV/EV | 14.2 | 0.7 | 14.0 | 0.8 | 14.6 | 0.9 | 14.1 | 0.8 | 5.7%  |
|  IMP | 10.7 | 0.7 | 11.1 | 1.0 | 11.0 | 1.0 | 10.8 | 0.9 | 8.5%  |
|  Flu A | 15.4 | 1.4 | 15.3 | 1.3 | 15.9 | 1.3 | 15.4 | 1.3 | 8.7%  |
|  Flu B | 14.2 | 0.7 | 14.0 | 0.7 | 14.5 | 0.7 | 14.1 | 0.7 | 5.0%  |
|  KPC | 16.6 | 0.8 | 16.6 | 0.8 | 17.3 | 1.2 | 16.7 | 1.0 | 5.9%  |

{7}

|  Analyte | Site 1 |   | Site 2 |   | Site 3 |   | All External Sites  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | %CV  |
|  L. pneumophila | 13.8 | 0.8 | 13.7 | 0.7 | 14.4 | 0.9 | 13.8 | 0.8 | 6.0%  |
|  mecA/C | 14.5 | 0.9 | 15.1 | 1.2 | 15.0 | 1.1 | 14.7 | 1.1 | 7.5%  |
|  MREJ | 14.2 | 0.8 | 14.7 | 1.3 | 14.5 | 1.2 | 14.3 | 1.1 | 7.8%  |
|  S. aureus1 | 13.5 | 0.7 | 14.0 | 1.0 | 13.8 | 1.1 | 13.6 | 1.0 | 7.1%  |
|  S. aureus 2 | 14.3 | 0.7 | 14.8 | 1.0 | 14.7 | 1.0 | 14.5 | 0.9 | 6.5%  |
|  MERS 1 | 15.7 | 1.1 | 15.6 | 0.8 | 16.3 | 1.1 | 15.7 | 1.0 | 6.7%  |
|  MERS 2 | 14.5 | 1.3 | 14.4 | 1.0 | 15.0 | 1.2 | 14.5 | 1.2 | 8.1%  |
|  M. pneumoniae | 13.6 | 0.6 | 13.4 | 0.6 | 13.8 | 0.8 | 13.5 | 0.7 | 4.9%  |
|  NDM | 12.3 | 1.0 | 13.1 | 1.0 | 13.3 | 1.3 | 12.8 | 1.1 | 8.9%  |
|  OXAa | 13.8 | 0.7 | 13.5 | 0.7 | 14.1 | 0.8 | 13.6 | 0.7 | 5.4%  |
|  PIV | 13.7 | 0.6 | 13.5 | 0.7 | 14.0 | 0.6 | 13.6 | 0.7 | 4.9%  |
|  S. agalactiae | 12.6 | 0.7 | 13.1 | 1.0 | 13.0 | 1.0 | 12.8 | 0.9 | 7.3%  |
|  S. pneumoniae | 12.6 | 0.7 | 13.0 | 0.9 | 13.0 | 0.9 | 12.7 | 0.9 | 6.9%  |
|  S. pyogenes | 13.0 | 0.6 | 13.3 | 0.9 | 13.3 | 0.9 | 13.0 | 0.9 | 6.6%  |
|  VIM | 13.0 | 0.7 | 13.6 | 0.9 | 13.6 | 1.2 | 13.3 | 1.0 | 7.3%  |
|  RSV | 12.0 | 0.5 | 11.8 | 0.6 | 12.2 | 0.7 | 11.9 | 0.6 | 5.3%  |

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

## b. Precision:

An internal precision study for the FilmArray Pneumonia/Pneumoniaplus Control was conducted over sixty days by testing three FilmArray Pneumonia/Pneumoniaplus Control Panel lots with three FilmArray Pneumonia/Pneumoniaplus assay lots performed by three operators using two FilmArray 2.0 instruments. All Positive Controls gave correct results except for 3 which gave false negative results. Repeat tests gave correct results on the first retest. All Negative Controls gave correct results. The results are shown in the Table 4 below:

{8}

Table 4: FilmArray Pneumonia/Pneumoniaplus Control Precision Summary

|  Category | #expected results/#tested1 | Overall Percent Agreement | 95% Confidence Interval  |
| --- | --- | --- | --- |
|  FilmArray Pneumonia/Pneumoniaplus Negative Control | 60/60 | 100% | 94% to 100%  |
|  FilmArray Pneumonia/Pneumoniaplus Positive Control | 60/63* | 95% | 86.9% to 98.4%  |

Expected result for the FilmArray Pneumonia/Pneumoniaplus Positive Control is positive. Expected result for the FilmArray Pneumonia/Pneumoniaplus Negative Control is negative.
* Three Positive controls gave initial false negative results, all produced the correct results upon a single retest

Table 5: Precision Internal Crossing Point (Cp) Summary

|  Analyte | D04MAY18A |   | A29MAY18A |   | C12JUN18A |   | All Lots  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | %CV  |
|  Acinetobacter | 16.2 | 1.1 | 16.2 | 1.4 | 15.7 | 1.2 | 16.0 | 1.2 | 7.6%  |
|  Adenovirus 2 | 13.3 | 1.9 | 13.4 | 2.4 | 12.5 | 1.4 | 13.1 | 2.0 | 15.2%  |
|  Adenovirus 3 | 11.9 | 2.0 | 11.8 | 2.2 | 10.6 | 0.9 | 11.4 | 1.9 | 16.4%  |
|  Adenovirus 7 | 12.2 | 1.3 | 12.2 | 1.6 | 11.7 | 1.4 | 12.0 | 1.5 | 12.2%  |
|  C. pneumoniae | 12.7 | 0.6 | 12.9 | 0.7 | 12.8 | 0.4 | 12.8 | 0.6 | 4.6%  |
|  Coronavirus | 17.0 | 0.7 | 17.3 | 0.8 | 17.2 | 0.7 | 17.2 | 0.7 | 4.3%  |
|  CTX-M | 14.6 | 2.0 | 14.8 | 2.4 | 13.9 | 1.1 | 14.4 | 1.9 | 13.3%  |
|  E. coli | 13.2 | 1.7 | 13.2 | 1.9 | 12.3 | 0.9 | 12.9 | 1.6 | 12.2%  |
|  Enterobacter 1 | 14.5 | 1.9 | 14.6 | 2.2 | 13.4 | 1.2 | 14.2 | 1.9 | 13.2%  |
|  Enterobacter 2 | 13.9 | 1.7 | 14.0 | 2.1 | 13.2 | 1.2 | 13.7 | 1.7 | 12.6%  |
|  H. influenzae | 14.3 | 1.5 | 14.2 | 1.8 | 13.9 | 1.4 | 14.1 | 1.6 | 11.3%  |
|  K. oxytoca | 14.1 | 2.0 | 14.2 | 2.4 | 12.9 | 1.1 | 13.7 | 2.0 | 14.6%  |
|  K. pneumoniae | 16.1 | 1.6 | 16.2 | 1.9 | 15.0 | 0.9 | 15.7 | 1.6 | 10.3%  |
|  M. catarrhalis | 13.6 | 1.3 | 13.6 | 1.5 | 12.9 | 1.2 | 13.4 | 1.4 | 10.3%  |
|  P. aeruginosa | 16.2 | 2.2 | 16.2 | 2.5 | 15.1 | 0.9 | 15.8 | 2.0 | 12.7%  |
|  Proteus | 15.2 | 1.1 | 15.2 | 1.3 | 14.6 | 0.8 | 15.0 | 1.1 | 7.3%  |
|  S. marcescens | 15.6 | 1.2 | 15.5 | 1.5 | 14.8 | 1.0 | 15.3 | 1.3 | 8.4%  |
|  hMPV | 17.2 | 0.9 | 17.5 | 1.1 | 17.6 | 2.1 | 17.4 | 1.5 | 8.4%  |
|  HRV/EV | 14.8 | 1.3 | 15.1 | 1.4 | 14.6 | 0.5 | 14.8 | 1.2 | 7.9%  |
|  IMP | 11.5 | 1.3 | 11.4 | 1.6 | 11.1 | 1.5 | 11.4 | 1.5 | 12.8%  |
|  Flu A | 16.4 | 1.5 | 16.7 | 1.6 | 16.0 | 0.8 | 16.4 | 1.4 | 8.3%  |
|  Flu B | 14.7 | 0.7 | 15.0 | 0.7 | 14.7 | 0.4 | 14.8 | 0.6 | 4.2%  |
|  KPC | 17.5 | 1.3 | 17.8 | 1.5 | 16.9 | 0.8 | 17.4 | 1.3 | 7.4%  |
|  L. pneumophila | 14.4 | 1.0 | 14.7 | 1.0 | 14.2 | 0.5 | 14.4 | 0.9 | 6.1%  |
|  mecA/C | 15.2 | 1.2 | 15.1 | 1.5 | 14.8 | 1.2 | 15.0 | 1.3 | 8.5%  |
|  MREJ | 14.8 | 1.2 | 14.6 | 1.5 | 14.7 | 1.8 | 14.7 | 1.5 | 10.3%  |
|  S. aureus 1 | 14.0 | 1.1 | 14.0 | 1.4 | 13.7 | 1.1 | 13.9 | 1.2 | 8.5%  |

{9}

|  Analyte | D04MAY18A |   | A29MAY18A |   | C12JUN18A |   | All Lots  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  S. aureus 2 | 15.0 | 1.1 | 14.9 | 1.3 | 14.5 | 1.0 | 14.8 | 1.2 | 7.8%  |
|  MERS1 | 16.6 | 1.2 | 16.9 | 0.9 | 16.5 | 0.5 | 16.7 | 0.9 | 5.6%  |
|  MERS2 | 15.3 | 1.3 | 15.6 | 1.2 | 15.2 | 0.8 | 15.4 | 1.1 | 7.1%  |
|  M. pneumoniae | 14.0 | 0.6 | 14.2 | 0.7 | 14.2 | 0.6 | 14.1 | 0.6 | 4.4%  |
|  NDM | 13.2 | 1.8 | 13.2 | 2.2 | 12.0 | 1.0 | 12.8 | 1.8 | 14.1%  |
|  OXAa | 14.2 | 0.9 | 14.5 | 0.9 | 14.0 | 0.6 | 14.3 | 0.8 | 5.8%  |
|  PIV | 13.9 | 0.6 | 14.2 | 0.7 | 14.0 | 0.8 | 14.0 | 0.7 | 4.9%  |
|  S. agalactiae | 13.1 | 1.2 | 13.1 | 1.3 | 12.9 | 1.1 | 13.0 | 1.2 | 9.0%  |
|  S. pneumoniae | 13.2 | 1.3 | 13.2 | 1.5 | 12.5 | 1.0 | 13.0 | 1.3 | 9.8%  |
|  S. pyogenes | 13.6 | 1.0 | 13.6 | 1.3 | 13.3 | 0.9 | 13.5 | 1.1 | 7.9%  |
|  VIM | 13.9 | 1.4 | 13.8 | 1.7 | 13.0 | 0.9 | 13.5 | 1.4 | 10.2%  |
|  RSV | 12.0 | 0.6 | 12.3 | 0.6 | 12.1 | 0.7 | 12.1 | 0.6 | 5.2%  |

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 precision was demonstrated in a separate study conducted by one operator testing one lot of FilmArray Pneumonia/Pneumoniaplus Control with one lot of FilmArray Pneumonia/Pneumonia plus pouches on the FilmArray 2.0, each within one day. The results are shown in the tables below:

Table 6: FilmArray Pneumonia/Pneumoniaplus Control Panel Summary of Within-run Precision

|  Control | #expected results/#tested1 | Overall Percent Agreement | 95% Confidence Interval  |
| --- | --- | --- | --- |
|  FilmArray Pneumonia / Pneumoniaplus Positive Control | 6/6 | 100% | 61%-100%  |
|  FilmArray Pneumonia / Pneumoniaplus Negative Control | 6/6 | 100% | 61%-100%  |

Expected result for the FilmArray Pneumonia/Pneumoniaplus Positive Control is positive. Expected result for the FilmArray Pneumonia/Pneumoniaplus Negative Control is negative.

{10}

Table 7: Within-run Precision Internal Crossing Point (Cp) Summary

|  Analyte | Mean Cp | Standard Deviation  |
| --- | --- | --- |
|  Acinetobacter | 15.7 | 0.8  |
|  Adenovirus 2 | 12.8 | 1.9  |
|  Adenovirus 3 | 11.5 | 1.5  |
|  Adenovirus 7 | 11.4 | 0.5  |
|  C. pneumoniae | 12.9 | 0.2  |
|  Coronavirus | 17.8 | 0.5  |
|  CTX-M | 14.1 | 1.6  |
|  E. coli | 12.5 | 1.1  |
|  Enterobacter 1 | 13.7 | 1.2  |
|  Enterobacter 2 | 13.1 | 1.0  |
|  H. influenzae | 13.0 | 0.3  |
|  K. oxytoca | 13.2 | 1.2  |
|  K. pneumoniae | 15.9 | 1.0  |
|  M. catarrhalis | 13.1 | 0.5  |
|  P. aeruginosa | 15.6 | 1.7  |
|  Proteus | 14.5 | 0.6  |
|  S. marcescens | 15.1 | 0.6  |
|  hMPV | 17.0 | 0.7  |
|  HRV/EV | 14.6 | 0.8  |
|  IMP | 10.7 | 0.7  |
|  Flu A | 16.9 | 0.8  |
|  Flu B | 15.1 | 0.3  |
|  KPC | 17.8 | 0.6  |
|  L. pneumophila | 14.7 | 0.7  |
|  mecA/C | 14.2 | 0.4  |
|  MREJ | 13.7 | 0.3  |
|  S. aureus 1 | 13.4 | 0.4  |
|  S. aureus 2 | 14.2 | 0.4  |
|  MERS1 | 17.1 | 0.8  |
|  MERS2 | 16.1 | 0.7  |
|  M. pneumoniae | 14.1 | 0.3  |
|  NDM | 12.9 | 1.5  |
|  OXAa | 14.7 | 0.5  |
|  PIV | 14.1 | 0.3  |
|  S. agalactiae | 12.3 | 0.3  |
|  S. pneumoniae | 12.3 | 0.6  |
|  S. pyogenes | 12.9 | 0.4  |
|  VIM | 13.3 | 0.6  |
|  RSV | 12.0 | 0.1  |

Within-run reproducibility studies for the FilmArray Pneumonia/Pneumoniaplus Control are acceptable.

{11}

d. Lot-to-Lot Testing:

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

Table 8: FilmArray Pneumonia/Pneumoniaplus Control Panel Summary of Lot-to-Lot Reproducibility

|  Control Lot # | Number of Tests | Pouch Lot | Correct Results  |
| --- | --- | --- | --- |
|  D04MAY18A | 7 | 697017 | 7/7  |
|  A29MAY18A | 8 | 697017 | 7/8*  |
|  C12JUN18A | 7 | 697017 | 7/7  |

*1 false negative result for hMPV

Table 9: Lot to Lot Internal Crossing Point (Cp) Summary

|  Analyte | D04MAY18A | A29MAY18A | C12JUN18A | All lots | All Lots  |
| --- | --- | --- | --- | --- | --- |
|   |  Mean Cp | Mean Cp | Mean Cp | Mean Cp | SD  |
|  Acinetobacter | 15.5 | 15.1 | 15.0 | 15.2 | 0.5  |
|  Adenovirus 2 | 12.3 | 11.8 | 11.9 | 12.0 | 0.9  |
|  Adenovirus 3 | 10.7 | 10.4 | 10.2 | 10.5 | 0.7  |
|  Adenovirus 7 | 11.2 | 10.7 | 10.9 | 10.9 | 0.4  |
|  C. pneumoniae | 12.4 | 12.6 | 12.6 | 12.5 | 0.4  |
|  Coronavirus | 17.4 | 17.7 | 17.5 | 17.5 | 0.4  |
|  CTX-M | 13.4 | 13.1 | 13.4 | 13.3 | 0.7  |
|  E. coli | 11.9 | 11.7 | 11.6 | 11.7 | 0.5  |
|  Enterobacter 1 | 13.1 | 12.8 | 12.9 | 12.9 | 0.5  |
|  Enterobacter 2 | 12.5 | 12.3 | 12.3 | 12.4 | 0.5  |
|  H. influenzae | 12.8 | 12.4 | 12.7 | 12.7 | 0.3  |
|  K. oxytoca | 12.6 | 12.3 | 12.2 | 12.4 | 0.6  |
|  K. pneumoniae | 15.4 | 15.2 | 14.8 | 15.1 | 0.5  |
|  M. catarrhalis | 12.7 | 12.4 | 12.4 | 12.5 | 0.4  |
|  P. aeruginosa | 15.0 | 14.5 | 14.7 | 14.7 | 0.7  |
|  Proteus | 14.3 | 14.0 | 14.0 | 14.1 | 0.4  |
|  S. marcescens | 15.0 | 14.3 | 14.8 | 14.7 | 0.4  |
|  hMPV | 17.0 | 16.9 | 17.2 | 17.1 | 0.7  |
|  HRV/EV | 14.0 | 14.3 | 14.3 | 14.2 | 0.5  |
|  IMP | 10.5 | 10.0 | 10.2 | 10.2 | 0.5  |
|  Flu A | 16.6 | 16.9 | 16.1 | 16.6 | 0.7  |
|  Flu B | 14.5 | 14.8 | 14.7 | 14.7 | 0.4  |
|  KPC | 17.2 | 17.3 | 17.0 | 17.2 | 0.5  |
|  L. pneumophila | 14.2 | 14.5 | 14.2 | 14.3 | 0.6  |
|  mecA/C | 14.0 | 13.7 | 13.9 | 13.8 | 0.3  |

{12}

|  Analyte | D04MAY18A | A29MAY18A | C12JUN18A | All lots | All Lots  |
| --- | --- | --- | --- | --- | --- |
|   |  Mean Cp | Mean Cp | Mean Cp | Mean Cp | SD  |
|  MREJ | 13.6 | 13.2 | 13.7 | 13.5 | 0.4  |
|  S. aureus 1 | 13.2 | 12.8 | 13.2 | 13.1 | 0.4  |
|  S. aureus 2 | 14.2 | 13.7 | 14.1 | 14.0 | 0.4  |
|  MERS1 | 16.7 | 16.8 | 16.5 | 16.7 | 0.7  |
|  MERS2 | 15.6 | 15.9 | 15.4 | 15.6 | 0.7  |
|  M. pneumoniae | 13.7 | 13.9 | 14.1 | 13.9 | 0.5  |
|  NDM | 12.0 | 11.9 | 11.4 | 11.8 | 0.6  |
|  OXAa | 14.2 | 14.3 | 14.3 | 14.3 | 0.5  |
|  PIV | 13.6 | 13.9 | 13.9 | 13.8 | 0.4  |
|  S. agalactiae | 12.2 | 11.9 | 12.1 | 12.1 | 0.3  |
|  S. pneumoniae | 12.0 | 11.8 | 11.8 | 11.9 | 0.4  |
|  S. pyogenes | 12.7 | 12.4 | 12.7 | 12.6 | 0.4  |
|  VIM | 12.8 | 12.5 | 12.5 | 12.6 | 0.3  |
|  RSV | 11.6 | 12.0 | 11.8 | 11.8 | 0.4  |

Lot-to-Lot reproducibility studies for the FilmArray Pneumonia/Pneumoniaplus 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 Pneumonia/Pneumoniaplus Control 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 Pneumonia/Pneumoniaplus Control. Based on this study, the FilmArray Pneumonia/Pneumoniaplus Control is expected to be stable until the expiration date (24 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

{13}

Pneumonia/Pneumoniaplus Control 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 Pneumonia/Pneumoniaplus Control 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 Pneumonia/Pneumoniaplus Control 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 lots of the FilmArray Pneumonia/Pneumoniaplus Positive control that was placed in dry ice that was stored for two days at ambient temperature of approximately  $19-21^{\circ}\mathrm{C}$  and then tested using the FilmArray Pneumonia/Pneumonia plus assay. To simulate a shipping delay, additional samples of the two lots of the Positive Control that had been stored in dry ice, were removed from the dry ice and placed at ambient temperature for six days. The 'delayed' samples were tested at two and six days of ambient temperature with the FilmArray Pneumonia/Pneumonia plus assay.

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

# Expected Values:

FilmArray Pneumonia/Pneumoniaplus Control is a qualitative control and the expected results are listed in the tables below.

Table 10: FilmArray Pneumonia/Pneumoniaplus Positive & Negative Result Summary

|  Result Summary  |   |   |   |
| --- | --- | --- | --- |
|   | Positive M34235 |   | Negative M34135  |
|  Bacteria |   | Bin † (copies/mL) |   |
|  Acinetobacter calcoaceticus-baumannii complex | Detected | 10^5 | Not Detected  |
|  Enterobacter cloacae complex | Detected | 10^6 | Not Detected  |
|  Escherichia coli | Detected | 10^5 | Not Detected  |
|  Haemophilus influenzae | Detected | 10^5 | Not Detected  |
|  Klebsiella aerogenes | Detected | 10^5 | Not Detected  |
|  Klebsiella oxytoca | Detected | 10^5 | Not Detected  |
|  Klebsiella pneumoniae group | Detected | 10^5 | Not Detected  |
|  Moraxella catarrhalis | Detected | 10^5 | Not Detected  |
|  Proteus spp. | Detected | 10^5 | Not Detected  |
|  Pseudomonas aeruginosa | Detected | 10^5 | Not Detected  |

{14}

|  Result Summary  |   |   |   |
| --- | --- | --- | --- |
|  Serratia marcescens | Detected | 10^6 | Not Detected  |
|  Staphylococcus aureus | Detected | 10^6 | Not Detected  |
|  Streptococcus agalactiae | Detected | 10^6 | Not Detected  |
|  Streptococcus pneumoniae | Detected | 10^5 | Not Detected  |
|  Streptococcus pyogenes | Detected | 10^6 | Not Detected  |
|  Antimicrobial Resistance Genes  |   |   |   |
|  CTX-M | Detected |  | N/A  |
|  IMP | Detected |   | N/A  |
|  KPC | Detected |   | N/A  |
|  mecA/C and MREJ | Detected |   | N/A  |
|  NDM | Detected |   | N/A  |
|  OXA-48-like | Detected |   | N/A  |
|  VIM | Detected |   | N/A  |
|  Atypical Bacteria  |   |   |   |
|  Chlamydia pneumoniae | Detected |  | Not Detected  |
|  Legionella pneumophila | Detected |   | Not Detected  |
|  Mycoplasma pneumoniae | Detected |   | Not Detected  |
|  Viruses  |   |   |   |
|  Adenovirus | Detected |  | Not Detected  |
|  Coronavirus | Detected |   | Not Detected  |
|  Human Metapneumovirus | Detected |   | Not Detected  |
|  Human Rhinovirus/Enterovirus | Detected |   | Not Detected  |
|  Influenza A | Detected |   | Not Detected  |
|  Influenza B | Detected |   | Not Detected  |
|  Middle East Respiratory Syndrome Coronavirus (MERS-CoV)‡ | Detected |   | Not Detected  |
|  Parainfluenza Virus | Detected |   | Not Detected  |
|  Respiratory Syncytial Virus | Detected |   | Not Detected  |

† Bins (copies/ mL) are approximate and may vary run to run.
‡ Middle East Respiratory Syndrome Coronavirus is reported on FilmArray Pneumonia Panelplus assay only.

## Matrix Effects:

A study was performed to evaluate the effect of the FilmArray Pneumonia/Pneumoniaplus Control Panel in the presence of sputum matrix. A sputum sample positive for *M. catarrhalis* was spiked into a negative (by culture) sputum patient sample and into a negative MMQCI matrix sample and tested in triplicate by the FilmArray Pneumonia/Pneumonia plus assay. No inhibition and/or false negative results were observed with either the spiked clinical patient sample or MMQCI's negative matrix.

Results demonstrated that samples prepared with FilmArray Pneumonia/Pneumoniaplus Control sputum matrix showed no inhibition and/or false negative results were observed with either the spiked clinical patient sample or MMQCI's negative matrix.

{15}

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.

N. Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

{16}

O. Conclusion:

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

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K190222](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K190222)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com