← Product Code [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN) · K202196

# BioFire RP2.1/RP2.1plus Control Panel M441 (K202196)

_Maine Molecular Quality Controls, Inc. · PMN · Jun 24, 2021 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K202196

## Device Facts

- **Applicant:** Maine Molecular Quality Controls, Inc.
- **Product Code:** [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN.md)
- **Decision Date:** Jun 24, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3920
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

BioFire RP2.1/RP2.1plus Control Panel M441 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 H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1 plus) and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays performed on BioFire FilmArray® systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1, BioFire RP2.1plus and BioFire RP2.1-EZ assays. This product is not intended to replace manufacturer controls provided with the device.

## Device Story

BioFire RP2.1/RP2.1plus Control Panel M441 consists of two ready-to-use liquid controls: a positive control containing synthetic RNA transcripts of respiratory pathogens and a negative control containing buffer/preservatives. Used in clinical laboratories to monitor the qualitative amplification, detection, and identification steps of BioFire Respiratory Panel 2.1, 2.1plus, and 2.1-EZ assays on BioFire FilmArray systems. The control is processed identically to patient nasopharyngeal swab samples in Viral Transport Media. Healthcare providers use the control results to verify the performance of the nucleic acid testing procedure. Successful detection of the control targets confirms the assay is functioning correctly, ensuring reliable patient test results.

## Clinical Evidence

No clinical data. Bench testing only. External and internal precision studies were conducted using three lots of control material and three lots of assay pouches on FilmArray 2.0 and Torch systems. Results showed 100% agreement with expected results for both positive and negative controls. Crossing point (Cp) values demonstrated acceptable reproducibility across operators, days, and lots. Stability studies confirmed 24-month shelf life at -20°C and stability after shipping delays.

## Technological Characteristics

Ready-to-use liquid control. Positive control: synthetic RNA transcripts in buffer, stabilizers, and preservatives. Negative control: buffer and preservatives. Monitors reverse transcription, amplification, detection, and identification steps of BioFire FilmArray assays. No electronic components or software algorithms; functions as a biological/chemical reference material.

## 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 RP2/RP2plus Control Panel ([K173171](/device/K173171.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:
K202196

B. Purpose for Submission:
To obtain a substantial equivalence determination for the BioFire RP2.1/RP2.1plus Control Panel M441

C. Measurand:
Multi-analyte quality control materials

D. Type of Test:
BioFire RP2.1/RP2.1plus 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, BioFire RP2.1 and RP2.1plus assays on the BioFire FilmArray Systems, 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, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae

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

F. Proprietary and Established Names:
BioFire RP2.1/RP2.1plus Control Panel M441
BioFire RP2.1/RP2.1plus Control

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):

BioFire RP2.1/RP2.1plus Control Panel M441 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 H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1 plus (RP2.1plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assays performed on BioFire FilmArray systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1, BioFire RP2.1plus and BioFire RP2.1-EZ 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:

The BioFire RP2.1/RP2.1plus Control Panel was evaluated on the FilmArray 2.0 instrument.

I. Device Description:

BioFire RP2.1/RP2.1plus Control Panel M441, P/N M441, is a quality control panel consisting of 2 ready-to-use, liquid controls, BioFire RP2.1/RP2.1plus Positive (Positive Control) and BioFire RP2.1/RP2.1plus Negative, (Negative Control). The Positive Control contains non-infectious surrogate control material; a solution of synthetic RNA transcripts in

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buffer, stabilizers and preservatives. The RNA carries segments of all respiratory pathogens detected by the BioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1plus (RP2.1plus), and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assays (Table 1. below) on the BioFire FilmArray systems, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). BioFire RP2.1/RP2.1plus Negative contains buffer and preservatives with no RNA. Each liquid control of BioFire RP2.1/RP2.1plus.

Control Panel M441 is processed separately according to BioFire RP2.1, RP2.1plus, and RP2.1-EZ assays manufacturer's Instructions for Use for patient samples (nasopharyngeal swabs) obtained from individuals suspected of respiratory tract infection and placed in Viral Transport Media (VTM)).

Table 1: Pathogens Detected by BioFire RP2.1, RP2.1plus, and RP2.1-EZ assays.

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

*Detected by BioFire RP2.1plus assay only.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

FilmArray RP2/RP2plus Control Panel, Maine Molecular Quality Controls, Inc.

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

K173171

3. Comparison with predicate:

Similarities

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device: BioFire RP2.1/RP2.1plus Control (K202196) | Prdeciate: FilmArray Pneumonia/Pneumoniaplus Control (K173171)  |
|  **Intended Use** | BioFire RP2.1/RP2.1plus Control Panel M441 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 H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BioFire Respiratory Panel 2.1 (RP2.1) and BioFire Respiratory Panel 2.1plus (RP2.1plus) assays performed on the BioFire FilmArray 2.0 and Torch systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire RP2.1 assay and BioFire RP2.1plus assay. This product is not intended to replace manufacturer internal controls provided with the device. | 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.  |
|  **Physical Format** | Same | Ready-to-Use Liquid  |
|  **Directions for Use** | Same | Process like patient sample  |
|  **Assay Steps Monitored** | Same | Reverse transcription, amplification, detection, identification  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Number of Targets | Same | Multiple  |
|  Composition | Same | Synthetic RNA & DNA transcripts  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device: BioFire RP2.1/RP2.1plus Control (K202196) | Prdeciate: FilmArray Pneumonia/Pneumoniaplus Control (K173171)  |
|  Targets | 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, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae | 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  |

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. External Site Precision:

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An external site precision study was performed with the BioFire RP2.1/RP2.1plus Control Panel on FilmArray instrument 2.0 and FilmArray Torch systems. Multiple operators participated using three lots each of external control material and three lots of BioFire RP2.1 assays pouch lots were tested across all sites. A total of 52 external controls were tested (27 positive and 25 negative). The results are shown in the Tables 2 below:

Table 2: BioFire RP2.1/RP2.1plus Control Panel External Precision Study Summary

|  Category | #expected results/# tested1 | % Agreement with Expected Result 1 | Overall Percent Agreement | 95% Confidence Interval  |
| --- | --- | --- | --- | --- |
|  BioFire RP2.1/RP2.1plus Positive Control | 26/27* | 100% | 100% 26/26 | 87.1% to 100%%  |
|  BioFire RP2.1/RP2.1plus Negative Control | 25/25 | 100% | 100% 25/25 | 86.7% to 100%  |

* 1 Invalid sample was not included in the Percent Correct analysis.

Table 3: External Precision Crossing Point (Cp) Summary

|  Analyte | Lot #1 |   | Lot #2 |   | Lot #3 |   | All Lot #’s  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | %CV  |
|  Adeno2 | 18.6 | 3.1 | 18.0 | 0.7 | 18.1 | 1.6 | 18.3 | 2.1 | 11.6%  |
|  Adeno3 | 18.4 | 1.4 | 17.5 | 1.7 | 19.2 | 1.6 | 18.4 | 1.6 | 8.9%  |
|  Adeno6 | 16.1 | 1.0 | 15.4 | 1.3 | 16.7 | 1.1 | 16.1 | 1.2 | 7.5%  |
|  Adeno7.1 | 15.2 | 0.6 | 15.2 | 0.8 | 15.2 | 0.6 | 15.2 | 0.6 | 4.3%  |
|  Adeno8 | 13.7 | 0.4 | 13.7 | 0.7 | 14.1 | 0.5 | 13.8 | 0.5 | 3.8%  |
|  CoV-229E | 15.8 | 0.5 | 15.9 | 0.4 | 15.8 | 0.5 | 15.8 | 0.4 | 2.7%  |
|  CoV-HKU1 | 17.2 | 0.4 | 17.3 | 0.5 | 17.3 | 0.5 | 17.3 | 0.5 | 2.6%  |
|  CoV-NL63 | 16.0 | 0.5 | 16.1 | 0.5 | 16.1 | 0.6 | 16.1 | 0.5 | 3.1%  |
|  CoV-OC43-2 | 17.2 | 0.7 | 17.3 | 0.5 | 17.1 | 0.8 | 17.2 | 0.7 | 3.8%  |
|  MERS1 | 17.0 | 0.7 | 16.9 | 0.5 | 16.9 | 0.5 | 16.9 | 0.6 | 3.3%  |
|  MERS2 | 16.2 | 0.7 | 16.2 | 0.6 | 16.3 | 0.7 | 16.3 | 0.6 | 4.0%  |
|  SARSCoV2-1 | 12.4 | 0.3 | 12.4 | 0.4 | 12.2 | 0.3 | 12.4 | 0.4 | 2.9%  |
|  SARSCoV2-2 | 15.5 | 0.4 | 15.3 | 0.7 | 15.3 | 0.4 | 15.4 | 0.5 | 3.3%  |
|  hMPV | 14.5 | 0.7 | 14.3 | 0.8 | 14.3 | 0.7 | 14.4 | 0.7 | 4.8%  |
|  HRV/EV | 16.2 | 0.4 | 16.3 | 0.4 | 16.4 | 0.6 | 16.3 | 0.5 | 3.0%  |
|  FluA-H1-2 | 18.4 | 0.5 | 18.2 | 0.7 | 18.3 | 0.7 | 18.3 | 0.6 | 3.3%  |
|  FluA-H1-2009 | 17.8 | 0.5 | 17.8 | 0.5 | 17.8 | 0.5 | 17.8 | 0.5 | 2.7%  |
|  FluA-H3 | 15.3 | 0.5 | 15.5 | 0.4 | 15.4 | 0.5 | 15.4 | 0.4 | 2.8%  |
|  FluA-pan1 | 15.3 | 0.4 | 15.5 | 0.5 | 15.4 | 0.6 | 15.4 | 0.5 | 3.0%  |
|  FluA-pan2 | 16.1 | 0.4 | 16.2 | 0.5 | 16.0 | 0.7 | 16.1 | 0.5 | 3.2%  |

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|  Analyte | Lot #1 |   | Lot #2 |   | Lot #3 |   | All Lot #'s  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | %CV  |
|  FluB | 14.8 | 0.4 | 15.2 | 0.5 | 15.1 | 0.4 | 15.0 | 0.4 | 2.9%  |
|  PIV1 | 14.0 | 0.6 | 13.8 | 0.6 | 13.9 | 0.8 | 13.9 | 0.6 | 4.4%  |
|  PIV2 | 17.4 | 0.4 | 17.5 | 0.5 | 17.4 | 0.5 | 17.4 | 0.4 | 2.5%  |
|  PIV3 | 17.1 | 0.4 | 17.3 | 0.3 | 17.2 | 0.5 | 17.2 | 0.4 | 2.2%  |
|  PIV4 | 17.3 | 0.5 | 17.5 | 0.6 | 17.4 | 0.5 | 17.4 | 0.5 | 2.8%  |
|  RSV | 14.8 | 0.2 | 15.1 | 0.4 | 15.0 | 0.5 | 14.9 | 0.4 | 2.6%  |
|  IS1001 | 17.7 | 0.8 | 17.9 | 0.7 | 18.6 | 1.1 | 18.0 | 0.9 | 5.2%  |
|  ptxP | 15.4 | 1.1 | 15.0 | 1.1 | 16.0 | 1.2 | 15.5 | 1.2 | 7.5%  |
|  Cpne | 15.2 | 0.5 | 15.4 | 0.5 | 15.3 | 0.5 | 15.3 | 0.5 | 3.0%  |
|  Mpne | 15.5 | 0.3 | 15.6 | 0.4 | 15.4 | 0.5 | 15.5 | 0.4 | 2.5%  |

The results suggest that there are no significant differences between different users and different lots on different days. The external precision study for the BioFire RP2.1/RP2.1plus Control Panel are is acceptable.

## b. Internal Precision:

An internal precision study for the BioFire RP2.1/RP2.1plus Control Panel was conducted over twenty days by testing three BioFire RP2.1/RP2.1plus Control Panel lots with three BioFire RP2.1 assay lots performed by three operators using two FilmArray 2.0 instruments. The results are shown in the Table 4 below:

Table 4: BioFire RP2.1/RP2.1plus Control Panel Internal Precision Summary

|  Category | #expected results/#tested1 | Overall Percent Agreement | 95% Confidence Interval  |
| --- | --- | --- | --- |
|  BioFire RP2.1/RP2.1plus Negative Control | 60/60 | 100% | 94% to 100%  |
|  BioFire RP2.1/RP2.1plus Positive Control | 60/60 | 100% | 94% to 100%  |

Table 5: Precision Internal Crossing Point (Cp) Summary

|  Analyte | D24APR20A |   | F28APR20A |   | C29APR20A |   | All Lots  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | Ave Cp | SD | %CV  |
|  Adeno2 | 17.8 | 1.5 | 18.5 | 1.6 | 17.9 | 2.1 | 18.1 | 1.8 | 9.7%  |
|  Adeno3 | 18.1 | 1.5 | 18.3 | 1.5 | 17.8 | 1.7 | 18.1 | 1.6 | 8.7%  |
|  Adeno6 | 15.9 | 1.4 | 15.9 | 1.4 | 15.7 | 1.4 | 15.8 | 1.4 | 8.7%  |
|  Adeno7.1 | 16.1 | 1.8 | 16.1 | 1.2 | 15.7 | 1.3 | 16.0 | 1.4 | 9.0%  |
|  Adeno8 | 14.2 | 1.3 | 14.3 | 1.0 | 14.0 | 1.0 | 14.2 | 1.1 | 7.5%  |

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|  Analyte | D24APR20A |   | F28APR20A |   | C29APR20A |   | All Lots  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  CoV-229E | 16.3 | 0.8 | 16.8 | 0.7 | 16.2 | 0.7 | 16.4 | 0.8 | 4.7%  |
|  CoV-HKU1 | 17.7 | 1.2 | 17.9 | 0.7 | 17.6 | 0.8 | 17.7 | 0.9 | 5.1%  |
|  CoV-NL63 | 17.2 | 1.2 | 17.3 | 0.7 | 17.1 | 0.9 | 17.2 | 0.9 | 5.4%  |
|  CoV-OC43-2 | 18.3 | 1.7 | 18.4 | 0.9 | 18.3 | 1.3 | 18.3 | 1.3 | 7.2%  |
|  MERS1 | 17.9 | 1.8 | 18.0 | 0.8 | 17.9 | 1.4 | 17.9 | 1.4 | 7.6%  |
|  MERS2 | 16.9 | 1.2 | 17.2 | 0.7 | 16.9 | 1.1 | 17.0 | 1.0 | 5.9%  |
|  SARSCoV2-1 | 13.2 | 0.8 | 13.4 | 0.5 | 12.9 | 0.6 | 13.2 | 0.7 | 5.2%  |
|  SARSCoV2-2 | 16.4 | 1.3 | 16.3 | 0.6 | 16.0 | 0.9 | 16.2 | 1.0 | 5.9%  |
|  hMPV | 15.4 | 1.7 | 15.3 | 1.1 | 14.9 | 1.2 | 15.2 | 1.4 | 9.1%  |
|  HRV/EV | 16.8 | 1.0 | 17.2 | 0.7 | 16.7 | 0.8 | 16.9 | 0.9 | 5.1%  |
|  FluA-H1-2 | 19.1 | 1.4 | 19.4 | 1.0 | 18.9 | 1.1 | 19.1 | 1.2 | 6.2%  |
|  FluA-H1-2009 | 18.4 | 1.5 | 18.5 | 0.9 | 18.3 | 1.1 | 18.4 | 1.2 | 6.4%  |
|  FluA-H3 | 15.9 | 0.8 | 16.4 | 0.5 | 16.0 | 0.7 | 16.1 | 0.7 | 4.2%  |
|  FluA-pan1 | 15.7 | 0.7 | 16.1 | 0.5 | 15.6 | 0.6 | 15.8 | 0.7 | 4.2%  |
|  FluA-pan2 | 16.8 | 1.1 | 17.1 | 0.9 | 16.6 | 0.8 | 16.8 | 0.9 | 5.6%  |
|  FluB | 15.4 | 0.7 | 15.9 | 0.4 | 15.5 | 0.5 | 15.6 | 0.6 | 3.8%  |
|  PIV1 | 15.0 | 1.6 | 15.0 | 1.1 | 14.8 | 1.2 | 14.9 | 1.3 | 8.9%  |
|  PIV2 | 18.1 | 1.3 | 18.3 | 0.8 | 17.9 | 0.9 | 18.1 | 1.0 | 5.5%  |
|  PIV3 | 17.7 | 1.2 | 18.0 | 0.8 | 17.6 | 0.8 | 17.8 | 1.0 | 5.4%  |
|  PIV4 | 17.9 | 1.2 | 18.4 | 0.8 | 17.9 | 0.9 | 18.1 | 1.0 | 5.5%  |
|  RSV | 15.4 | 0.8 | 15.8 | 0.5 | 15.5 | 0.5 | 15.6 | 0.6 | 4.1%  |
|  IS1001 | 18.1 | 1.0 | 18.6 | 1.0 | 18.2 | 1.1 | 18.3 | 1.0 | 5.7%  |
|  ptxP | 15.3 | 1.3 | 15.7 | 1.2 | 15.2 | 1.3 | 15.4 | 1.3 | 8.2%  |
|  Cpne | 15.7 | 0.8 | 16.2 | 0.6 | 15.6 | 0.6 | 15.8 | 0.7 | 4.5%  |
|  Mpne | 16.2 | 1.2 | 16.4 | 0.7 | 16.0 | 0.8 | 16.2 | 0.9 | 5.8%  |

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

c. Lot-to-Lot Testing:

Lot-to-lot reproducibility was demonstrated by testing three lots of BioFire RP2.1/RP2.1plus Positive using the same pouch lot. Results are shown in the following tables.

Table 6: BioFire RP2.1/RP2.1plus Positive Panel Summary of Lot-to-Lot Reproducibility

|  Control Lot # | Number of Tests | Pouch Lot | Correct Results  |
| --- | --- | --- | --- |
|  D24APR20 | 5 | 200409 | 5/5  |
|  F28APR20 | 5 | 200409 | 5/5  |
|  C29APR20 | 5 | 200409 | 5/5  |

Table 7: Lot to Lot Internal Crossing Point (Cp) Summary

{8}

|  Analyte | D24APR20 | F28APR20 | C29APR20 | All lots | All Lots  |
| --- | --- | --- | --- | --- | --- |
|   |  Mean Cp | Mean Cp | Mean Cp | Mean Cp | SD  |
|  Adeno2 | 18.9 | 18.9 | 19.0 | 18.9 | 0.1  |
|  Adeno3 | 19.3 | 19.8 | 19.4 | 19.5 | 0.3  |
|  Adeno6 | 16.8 | 17.2 | 16.7 | 16.9 | 0.2  |
|  Adeno7.1 | 16.6 | 16.9 | 16.5 | 16.7 | 0.2  |
|  Adeno8 | 14.6 | 14.9 | 14.6 | 14.7 | 0.2  |
|  CoV-229E | 16.8 | 16.9 | 16.8 | 16.8 | 0.1  |
|  CoV-HKU1 | 18.1 | 18.1 | 18.1 | 18.1 | 0.0  |
|  CoV-NL63 | 17.8 | 17.9 | 17.7 | 17.8 | 0.1  |
|  CoV-OC43-2 | 18.9 | 19.1 | 18.7 | 18.9 | 0.2  |
|  MERS1 | 18.9 | 18.8 | 18.8 | 18.8 | 0.1  |
|  MERS2 | 17.6 | 17.6 | 17.6 | 17.6 | 0.0  |
|  SARSCoV2-1 | 13.7 | 13.5 | 13.7 | 13.7 | 0.1  |
|  SARSCoV2-2 | 16.8 | 16.7 | 16.8 | 16.8 | 0.1  |
|  hMPV | 16.0 | 15.9 | 15.9 | 15.9 | 0.1  |
|  HRV/EV | 17.4 | 17.5 | 17.4 | 17.4 | 0.1  |
|  FluA-H1-2 | 19.7 | 20.0 | 19.6 | 19.7 | 0.2  |
|  FluA-H1-2009 | 18.9 | 18.9 | 18.8 | 18.8 | 0.1  |
|  FluA-H3 | 16.4 | 16.5 | 16.4 | 16.4 | 0.1  |
|  FluA-pan1 | 16.1 | 16.2 | 16.1 | 16.1 | 0.1  |
|  FluA-pan2 | 17.3 | 17.4 | 17.3 | 17.3 | 0.1  |
|  FluB | 15.7 | 15.9 | 15.8 | 15.8 | 0.1  |
|  PIV1 | 15.7 | 15.7 | 15.6 | 15.6 | 0.1  |
|  PIV2 | 18.6 | 18.7 | 18.5 | 18.6 | 0.1  |
|  PIV3 | 18.0 | 18.2 | 18.0 | 18.1 | 0.1  |
|  PIV4 | 18.4 | 18.5 | 18.3 | 18.4 | 0.1  |
|  RSV | 15.8 | 15.9 | 15.7 | 15.8 | 0.1  |
|  IS1001 | 18.9 | 19.3 | 18.9 | 19.0 | 0.3  |
|  ptxP | 16.1 | 16.5 | 16.1 | 16.3 | 0.2  |
|  Cpne | 16.1 | 16.2 | 16.1 | 16.2 | 0.1  |
|  Mpne | 16.8 | 16.7 | 16.6 | 16.7 | 0.1  |

Lot-to-Lot reproducibility studies for the BioFire RP2.1/RP2.1plus Positive Panel are acceptable.

e. Linearity/assay reportable range:

Not applicable

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

{9}

Traceability:

Not applicable

Stability:

Open Vial Stability: Not applicable because BioFire RP2.1/RP2.1plus Panel 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 BioFire RP2.1/RP2.1plus Panel Control. Based on this study, the BioFire RP2.1/RP2.1plus Panel Control is expected to be stable until the expiration date (24 months) when stored frozen (−20°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 BioFire RP2.1/RP2.1plus Panel 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 BioFire RP2.1/RP2.1plus Panel 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°C, as indicated in the BioFire RP2.1/RP2.1plus Panel 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 BioFire RP2.1/RP2.1plus Positive control that was placed in dry ice that was stored for two days at ambient temperature of approximately 19−21°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 BioFire RP2plus assay.

The study demonstrated that the BioFire RP2.1/RP2.1plus Positive Control is stable for two days on dry ice in MMQCI’s standard shipping box. BioFire RP2.1/RP2.1plus Positive Control is stable after six days at ambient temperatures of approximately 19−21°C. The FilmArray Pneumonia/Pneumoniaplus Positive Control should be stored frozen (−20°C or colder) as indicated in the package insert.

Expected Values:

BioFire RP2.1/RP2.1plus Panel Control is a qualitative control and the expected results are listed in the tables below.

Table 10: BioFire RP2.1/RP2.1plus Positive & Negative Result Summary
Result Summary

{10}

|  Result Summary  |   |   |
| --- | --- | --- |
|   | Positive | Negative  |
|  Viruses  |   |   |
|  Adenovirus | Detected | Not Detected  |
|  Coronavirus 229E | Detected | Not Detected  |
|  Coronavirus HKU1 | Detected | Not Detected  |
|  Coronavirus NL63 | Detected | Not Detected  |
|  Coronavirus OC43 | Detected | Not Detected  |
|  Middle East Respiratory Syndrome Coronavirus* (MERS-CoV)² | Detected | Not Detected  |
|  Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | Detected | Not Detected  |
|  Human Metapneumovirus | Detected | Not Detected  |
|  Human Rhinovirus/Enterovirus | Detected | Not Detected  |
|  Influenza A H1-2009¹ | Detected | Not Detected  |
|  Influenza A H3 | Detected | Not Detected  |
|  Influenza B | Detected | Not Detected  |
|  Parainfluenza Virus 1 | Detected | Not Detected  |
|  Parainfluenza Virus 2 | Detected | Not Detected  |
|  Parainfluenza Virus 3 | Detected | Not Detected  |
|  Parainfluenza Virus 4 | Detected | Not Detected  |
|  Respiratory Syncytial Virus | Detected | Not Detected  |
|  Bacteria  |   |   |
|  Bordetella parapertussis (IS1001) | Detected | Not Detected  |
|  Bordetella pertussis (ptxP) | Detected | Not Detected  |
|  Chlamydia pneumoniae | Detected | Not Detected  |
|  Mycoplasma pneumoniae | Detected | Not Detected  |

¹ BioFire RP2.1/RP2.1plus Positive contains both Influenza A H1 and Influenza A H1-2009. Due to BioFire FilmArray 2.0 Software calling algorithm, only Influenza A H1-2009 will report as Detected, just as if a co-infection of Influenza A H1-2009 and another Influenza A H1 has occurred. To confirm successful detection of Influenza A H1, view the melt curve by following BioFire’s Technical Note: Torch Melting Curve Analysis with FilmArray 2.0 Software. For questions related to software, please contact BioFire Technical Support.
² Middle East Respiratory Syndrome Coronavirus is reported on RP2.1plus assay only.

Matrix Effects:

A study was performed to evaluate the effect of the BioFire RP2.1/RP2.1plus Panel Control in the presence of VTM matrix. A VTM sample positive for Influenza A H1N1-2009 was spiked into a negative VTM and into a RP2/RP2plus Negative Control matrix and tested in triplicate by the FilmArray Pneumonia/Pneumonia plus assay. No inhibition and/or false negative results were observed with either the spiked sample in VTM or the RP2/RP2plus Negative Control matrix.

{11}

Results demonstrated that samples prepared with VTM matrix showed no inhibition and/or false negative results were observed with either the spiked sample or with the BioFire RP2/RP2plus Negative control matrix.

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.

{12}

N. Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

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/K202196](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K202196)

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