← Product Code [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN) · K200010

# FilmArray BCID2 Control Panel M416 (K200010)

_Maine Molecular Quality Controls, Inc. · PMN · Apr 2, 2020 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K200010

## Device Facts

- **Applicant:** Maine Molecular Quality Controls, Inc.
- **Product Code:** [PMN](/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN.md)
- **Decision Date:** Apr 2, 2020
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3920
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticusbaumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire Blood Culture Identification 2 (BCID2) Panel assay on FilmArray systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device.

## Device Story

Quality control panel consisting of positive and negative liquid controls; positive control contains non-infectious synthetic DNA in buffers/stabilizers/preservatives representing genome segments of pathogens/resistance genes detected by BioFire BCID2 Panel; negative control contains only buffers/stabilizers/preservatives. Used in clinical laboratories to monitor performance of nucleic acid testing procedures (amplification, detection, identification). Clinicians/technicians process controls like patient blood culture samples according to manufacturer instructions. Output provides verification of assay performance; helps ensure accuracy of clinical diagnostic results for sepsis-suspected patients.

## Clinical Evidence

No clinical data. Performance established via analytical bench testing. Multi-site reproducibility study (n=185) demonstrated 98% overall correct call rate. Internal precision study (n=62) showed 96.8% agreement for positive controls and 100% for negative controls. Within-run and lot-to-lot reproducibility studies confirmed consistent performance across different operators, instruments, and lots.

## Technological Characteristics

Ready-to-use liquid control; contains synthetic DNA transcripts in buffers, stabilizers, and preservatives. Single-use format. Designed for use with BioFire BCID2 Panel on FilmArray 2.0/Torch systems. No active sensing or energy source; purely 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 Pneumonia/Pneumoniaplus Control ([K190222](/device/K190222.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/).

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K200010

B Applicant

Maine Molecular Quality Controls, Inc.

C Proprietary and Established Names

FilmArray BCID2 Control Panel M416

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  PMN | Class II | 21 CFR 866.3920 - Assayed Quality Control Material for Clinical Microbiology Assays | MI - Microbiology  |

## II Submission/Device Overview:

A Purpose for Submission:

To obtain a substantial equivalence determination for the FilmArray BCID2 Control Panel M416

B Measurand:

Multi-analyte quality control materials

C Type of Test:

FilmArray BCID2 Control Panel M416 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 BCID2 Panel on the FilmArray 2.0 or FilmArray Torch systems. The BioFire BCID2 Panel on the FilmArray 2.0 or FilmArray Torch system detects multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance from positive blood cultures. Gram Positive Bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp. (with specific differentiation of Staphylococcus aureus, Staphylococcus epidermidis, and Staphylococcus

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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lugdunensis), Streptococcus spp. (with specific differentiation of Streptococcus agalactiae (Group B), Streptococcus pneumoniae, and Streptococcus pyogenes (Group A)), Gram-negative Bacteria: Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Haemophilus influenzae, Neisseria meningitidis (encapsulated), Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Enterobacterales (with specific differentiation of Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., and Serratia marcescens), Yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gatti, Resistance Markers: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B and VIM

## Intended Use/Indications for Use:

### Intended Use(s):

FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticusbaumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire Blood Culture Identification 2 (BCID2) Panel assay on FilmArray systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device.

### Indication(s) for Use:

See Intended Use.

### Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

For in vitro diagnostic use only

### Special Instrument Requirements:

The FilmArray BCID2 Control Panel was evaluated on the FilmArray 2.0 instrument.

### Device/System Characteristics:



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# A Device Description:

FilmArray BCID2 Control Panel M416, P/N M416, is a quality control panel consisting of 2 controls, FilmArray BCID2 Positive Control, P/N M41718, and FilmArray BCID2 Negative Control, P/N M41818. The Positive Control contains non-infectious surrogate control material; a solution of synthetic DNA in buffers, stabilizers and preservatives. The DNA in the Positive Control carries nucleic acid corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected and identified by the BioFire Blood Culture Identification 2 (BCID2) Panel assay (see table below) on the FilmArray systems. The Negative Control contains only buffers, stabilizers and preservatives. Each liquid control of FilmArray BCID2 Control Panel M416 is processed separately according to BioFire BCID2 Panel assay manufacturer's Instructions for Use for patient samples (positive blood cultures) obtained from individuals suspected of sepsis. Each tube of control contains sufficient liquid for a single use.

B Pathogens and antimicrobial resistance genes found in FilmArrayBCID2 Control Panel M416, detected by BioFire BCID2 Panel assay.

|  Antimicrobial resistance genes  |   |
| --- | --- |
|  CTX-M | mecA/C and MREJ (MRSA)  |
|  IMP | NDM  |
|  KPC | OXA-48-like  |
|  mcr-1 | vanA/B  |
|  mecA/C | VIM  |
|  Gram Positive Bacteria  |   |
|  Enterococcus faecalis | Streptococcus spp.  |
|  Enterococcus faecium | Streptococcus agalactiae (Group B)  |
|  Listeria monocytogenes | Streptococcus pneumoniae  |
|  Staphylococcus spp. | Streptococcus pyogenes (Group A)  |
|  Staphylococcus aureus |   |
|  Staphylococcus epidermidis |   |
|  Staphylococcus lugdunensis |   |
|  Gram Negative Bacteria  |   |
|  Acinetobacter calcoaceticus-baumannii complex | Enteric bacteria  |
|  Bacteroides fragilis | Enterobacter cloacae complex  |
|  Haemophilus influenzae | Escherichia coli  |
|  Neisseria meningitidis | Klebsiella aerogenes  |
|  Pseudomonas aeruginosa | Klebsiella oxytoca  |
|  Stenotrophomonas maltophilia | Klebsiella pneumoniae group  |
|   | Salmonella spp  |
|   | Serratia marcescens  |
|  Yeast  |   |
|  Candida albicans | Candida parapsilosis  |
|  Candida auris | Candida tropicalis  |
|  Candida glabrata | Cryptococcus neoformans/gattii  |
|  Candida krusei |   |

K200010 - Page 3 of 11

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C Principle of Operation:

Not applicable

V Substantial Equivalence Information:

A Predicate Device Name(s):

FilmArray Pneumonia/Pneumoniaplus Control

B Predicate 510(k) Number(s):

K190222

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K200010 | K190222  |
| --- | --- | --- |
|  Device Trade Name | FilmArray BCID2 Control Panel M416 | FilmArray Pneumonia/Pneumoniaplus Control  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | FilmArray BCID2 Control Panel M416 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 antimicrobial resistance genes: CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram-negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus baumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, | 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  |

K200010 - Page 4 of 11

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K200010 - Page 5 of 11
|   | Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire Blood Culture Identification 2 (BCID2) Panel assay on FilmArray systems. FilmArray BCID2 Control Panel M416 is composed of synthetic DNA specifically designed for and intended to be used solely with the BioFire BCID2 Panel assay. This product is not intended to replace manufacturer controls provided with the device. | 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  |
|  Number of targets monitored in one assay | Multiple, >30 targets | Same  |
|  General Device Characteristic Differences |  |   |
|  Targets | CTX-M, IMP, KPC, mcr-1, mecA/C, mecA/C and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram-negative bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus baumannii complex, Bacteroides fragilis, Enteric bacteria, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria | 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  |

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|   | meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii |   |
| --- | --- | --- |
|  Composition | Synthetic DNA transcripts | Synthetic DNA, and RNA transcripts  |

VI Standards/Guidance Documents Referenced:

None Referenced

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

A multi-site reproducibility study was performed with the FilmArray BCID2 Control Panel 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 different days. Multiple operators participated in testing at each of the three locations. Three lots each of external control material and three lots of BioFire BCID2 Panel pouch lots were tested across all sites, a total of 185 external controls were tested. Of the 185 controls tested, 2 gave an Invalid result and were retested according to BioFire Instructions for Use. Correct results were obtained for the retests. The Invalids were not included in the Percent Correct analysis in the table below. Out of 183 tests with valid pouch controls, the correct analytes were detected (for positive controls) or not detected (for negative controls) in 180 tests, for an overall correct call rate of 98%. Additional precision data can be found in the product labeling.

The results suggest that there are no significant differences between different users and different sites on different days. External reproducibility studies for the FilmArray BCID2 Control Panel are acceptable.

Precision

An internal precision study for the FilmArray BCID2 Control Panel was conducted over twenty different days by testing three FilmArray BCID2 Control Panel lots with three BioFire BCID2 Panel assay lots performed by four operators using two FilmArray 2.0 instruments. All controls gave correct results except for 2 positive controls which gave false negative results and upon retesting gave the correct result. The results are shown in the table below:

K200010 - Page 6 of 11

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Table: FilmArray BCID2 Control Precision Summary

|  Category | #expected results/#tested¹ | Overall Percent Agreement | 95% Confidence Interval  |
| --- | --- | --- | --- |
|  FilmArray BCID2BCID2 Negative Control | 60/60 | 100% | 94% to 100%  |
|  FilmArray BCID2BCID2 Positive Control | 60/62* | 96.8% | 89% to 99.1%  |

¹Expected result for the FilmArray BCID2 Positive Control is positive. Expected result for the FilmArray BCID2 Negative Control is negative.
* Two Positive controls gave initial false negative results, all produced the correct results upon a single retest

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

Within-run Testing

Within-run precision was demonstrated in a separate study conducted by one operator testing one lot of FilmArray BCID2 Control with one lot of BioFire BCID2 pouches on the FilmArray 2.0, each within one day. The results are shown in the tables below:

Table: FilmArray BCID2 Control Panel Summary of Within-run Precision

|  Control | #expected results/#tested¹ | Overall Percent Agreement | 95% Confidence Interval  |
| --- | --- | --- | --- |
|  FilmArray BCID2 Positive Control | 6/6 | 100% | 61%-100%  |
|  FilmArray BCID2 Negative Control | 6/6 | 100% | 61%-100%  |

¹Expected result for the FilmArray BCID2 Positive Control is positive. Expected result for the FilmArray BCID2 Negative Control is negative.

Within-run reproducibility studies for the FilmArray BCID2 Control are acceptable.

Lot-to-Lot Testing

Lot-to-lot reproducibility was demonstrated by testing three lots of FilmArray BCID2 Positive Control using the same pouch lot. Results are shown in the following tables.

Table: FilmArray BCID2 Control Panel Summary of Lot-to-Lot Reproducibility

|  Summary of Lot-to-Lot Testing  |   |   |   |
| --- | --- | --- | --- |
|  Control Lot # | Number of Tests | Pouch Lot | Correct Results  |
|  C19JUN19A | 6 | 604119 | 6/6  |
|  D20JUN19A | 6 | 604119 | 6/6  |
|  B24JUN19A | 6 | 604119 | 6/6  |

K200010 - Page 7 of 11

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Lot-to-Lot reproducibility studies for the FilmArray BCID2 Control Panel are acceptable. Additional data is provided in the product labeling.

2. Linearity:

Not applicable

3. Analytical Specificity/Interference:

Not applicable

4. Assay Reportable Range:

Not applicable

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Open Vial Stability

Not applicable because FilmArray BCID2 Control is packaged 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 BCID2 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 BCID2 Control on dry ice with overnight delivery (U.S.) or 4-7 days (ex-U.S.), ensuring that the control material remains cold upon receipt. The control material is then expected to be stored at 2-8°C upon receipt, as indicated in the FilmArray BCID2 Control package insert. A shipping study was performed to confirm the shipping process and to investigate the outcome of a possible shipping delay and consequent arrival with the gel packs no longer frozen or cold. The study evaluated two lots of the FilmArray BCID2 Positive control that was placed with 2 frozen gel packs. After 2 days, some vials were returned to the refrigerator at 2-8°C, and subsequently tested using the BioFire BCID2 Panel assay, thus representing usual customer receipt of product. To simulate a shipping delay, the remaining 'shipped' vials from the 2 lots of the FilmArray BCID2 Positive Control were removed from the shipping box after 2 days and stored for up to 6 days at ambient room temperature. The vials were then returned to the refrigerator and subsequently tested using the BioFire BCID2 Panel assay.

The study demonstrated that the FilmArray BCID2 Positive Control is stable for two days on frozen gel packs in MMQCI's standard shipping box. FilmArray BCID2 Positive Control is stable after six days at ambient temperatures of approximately 19-21°C. The FilmArray BCID2 Positive Control should be stored frozen (2-8°C) as indicated in the package insert.

K200010 - Page 8 of 11

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6. Detection Limit:
Not applicable

7. Assay Cut-Off:
Not applicable

## B Comparison Studies:

1. Method Comparison with Predicate Device:
Not applicable

2. Matrix Comparison:
The matrix of the FilmArray BCID2 Control Panel is synthetic, which allows for reproducible manufacturing, stability, provides a non-infectious material for the laboratory staff and carries the control DNA through the extraction process. Since the matrix is not identical to that of the routine BCID2 assay sample, blood culture media, a test was performed to investigate the effect of the matrix on the assay.

To confirm that the matrix has no effect on the assay or control, genomic DNA Streptococcus pneumoniae was spiked into the FilmArray BCID2 Negative Control, which contains the identical matrix found in the FilmArray BCID2 Positive Control, and tested in triplicate with the BioFire BCID2 assay. The same inactivated pathogen was spiked into BD BACTEC Ped. Plus/F Culture Vial with negative whole blood to simulate a clinical sample, which will also be tested in triplicate with the BioFire BCID2 assay.

Results demonstrated that samples prepared with FilmArray BCID2 Control whole blood showed no inhibition and/or false negative results.

## C Clinical Studies:

1. Clinical Sensitivity:
Not applicable

2. Clinical Specificity:
Not applicable

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable

K200010 - Page 9 of 11

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# D Clinical Cut-Off:

Not applicable

# E Expected Values/Reference Range:

FilmArray BCID2 Control is a qualitative control and the expected results are listed in the tables below.

Tables: FilmArray BCID2 Positive & Negative Result Summary

|  Result Summary  |   |   |
| --- | --- | --- |
|   | Positive Control | Negative Control  |
|  Antimicrobial resistance genes  |   |   |
|  CTX-M | Detected | N/A  |
|  IMP | Detected | N/A  |
|  KPC | Detected | N/A  |
|  mcr-1 | Detected | N/A  |
|  mecA/C | Detected | N/A  |
|  mecA/C and MREJ (MRSA) | Detected | N/A  |
|  NDM | Detected | N/A  |
|  OXA-48-like | Detected | N/A  |
|  vanA/B | Detected | N/A  |
|  VIM | Detected | N/A  |
|  Gram Positive Bacteria  |   |   |
|  Enterococcus faecalis | Detected | Not Detected  |
|  Enterococcus faecium | Detected | Not Detected  |
|  Listeria monocytogenes | Detected | Not Detected  |
|  Staphylococcus spp. | Detected | Not Detected  |
|  Staphylococcus aureus | Detected | Not Detected  |
|  Staphylococcus epidermidis | Detected | Not Detected  |
|  Staphylococcus lugdunensis | Detected | Not Detected  |
|  Streptococcus spp. | Detected | Not Detected  |
|  Streptococcus agalactiae (Group B) | Detected | Not Detected  |
|  Streptococcus pneumoniae | Detected | Not Detected  |
|  Streptococcus pyogenes (Group A) | Detected | Not Detected  |
|  Gram Negative Bacteria  |   |   |
|  Acinetobacter calcoaceticus-baumannii complex | Detected | Not Detected  |
|  Bacteroides fragilis | Detected | Not Detected  |
|  Enteric bacteria | Detected | Not Detected  |
|  Enterobacter cloacae complex | Detected | Not Detected  |
|  Escherichia coli | Detected | Not Detected  |
|  Klebsiella aerogenes | Detected | Not Detected  |
|  Klebsiella oxytoca | Detected | Not Detected  |
|  Klebsiella pneumoniae group | Detected | Not Detected  |
|  Proteus spp. | Detected | Not Detected  |
|  Salmonella spp. | Detected | Not Detected  |
|  Serratia marcescens | Detected | Not Detected  |
|  Haemophilus influenzae | Detected | Not Detected  |
|  Neisseria meningitidis | Detected | Not Detected  |

K200010 - Page 10 of 11

{10}

|  Result Summary  |   |   |
| --- | --- | --- |
|  Pseudomonas aeruginosa | Detected | Not Detected  |
|  Stenotrophomonas maltophilia | Detected | Not Detected  |
|  Yeast  |   |   |
|  Candida albicans | Detected | Not Detected  |
|  Candida auris | Detected | Not Detected  |
|  Candida glabrata | Detected | Not Detected  |
|  Candida krusei | Detected | Not Detected  |
|  Candida parapsilosis | Detected | Not Detected  |
|  Candida tropicalis | Detected | Not Detected  |
|  Cryptococcus neoformans/gattii | Detected | Not Detected  |

VIII Proposed Labeling:

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

IX Conclusion:

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

K200010 - Page 11 of 11

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K200010](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PMN/K200010)

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