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 and MREJ (MRSA), NDM, OXA-48-like, vanA/B, VIM; Gram positive and Gram negative bacteria: Enterococcus faccalis, Enterococcus faccium, Listeria monocytogenes, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococus spp., Streptococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenzae, Neisseria meningitidis, Pseudomonas aeruginosa and Stenotrophomonas maltophilia; and yeast pathogens: Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Cryptococcus neoformans/gattii on the BioFire® Blood Culture Identification 2 (BCID2) Panel on the 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 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 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 1. 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 contains sufficient liquid for a single use.

AI/ML Overview

This document describes the FilmArray BCID2 Control Panel M416, an assayed quality control device. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall correct result rate of 98.4% for Reproducibility study	Overall Correct Result Rate: 98.4% (300 correct results out of 305 valid tests) Details from Table 2:- Correct Positive Control Result: 150 - Incorrect Positive Control Result: 5 (96.8% correct for positive controls)- Correct Negative Control Result: 150- Incorrect Negative Control Result: 0 (100.0% correct for negative controls)- Invalid Results: 2 (excluded from percentage calculation, re-tested per BioFire instructions) Total Tests: 307

Acceptance Criteria

Reported Device Performance

Overall correct result rate of 98.4% for Reproducibility study

Overall Correct Result Rate: 98.4% (300 correct results out of 305 valid tests) Details from Table 2:- Correct Positive Control Result: 150 - Incorrect Positive Control Result: 5 (96.8% correct for positive controls)- Correct Negative Control Result: 150- Incorrect Negative Control Result: 0 (100.0% correct for negative controls)- Invalid Results: 2 (excluded from percentage calculation, re-tested per BioFire instructions) Total Tests: 307

2. Sample size used for the test set and the data provenance

Test Set Sample Size: 307 total tests were performed for the reproducibility study. After excluding 2 invalid results, 305 valid tests were used for the percentage calculation.
- Internal Testing (MMQCI): 122 tests (20 samples * 3 lots, with 2 repeats)
- External Testing (3 Clinical Laboratories): 186 tests (10 samples * 3 lots * 3 sites, with 6 repeats)
Data Provenance: The study involved both internal testing at MMQCI (Saco, Maine, USA) and external testing at 3 CLIA-certified clinical laboratories. The study was prospective in nature, as new lots of the control panel were manufactured and then tested according to a predefined protocol.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The device is a quality control material for nucleic acid testing, which typically has an objective ground truth based on the known composition of the synthetic DNA targets. The performance is assessed against the expected positive or negative result for each control.

4. Adjudication method for the test set

This information is not explicitly provided. Given the nature of a quality control material, the results are expected to be either positive or negative for predefined analytes. "Incorrect" results (positive controls) were retested, and those retested correctly are not included in the main performance summary (e.g., "The incorrect Positive controls were all correct upon retesting."). This suggests a form of retesting for discrepant results, rather than an expert adjudication panel.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This document describes a quality control material for in vitro diagnostic assays, not an AI-powered diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This device is a quality control material, not an algorithm. Its performance is evaluated by its ability to elicit the correct positive or negative response from the BioFire BCID2 Panel assay.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this quality control material is known composition.

Positive Control: Contains synthetic DNA corresponding to the genome segments of all the pathogens and antimicrobial resistance genes detected by the BioFire BCID2 Panel assay. Therefore, the expected ground truth for the positive control is the detection of all these targets.
Negative Control: Contains only buffers, stabilizers, and preservatives. The expected ground truth for the negative control is the absence of any detected targets.

8. The sample size for the training set

Not Applicable. This device is a quality control material, not a machine learning algorithm that requires a training set. Its manufacturing and testing involve standard analytical performance studies.

9. How the ground truth for the training set was established

Not Applicable. As explained above, there is no training set for this type of device.

Summary

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April 2, 2020

Maine Molecular Quality Controls, Inc. Joan Gordon President 23 Mill Brook Road Saco, Maine 04072

Re: K200010

Trade/Device Name: FilmArray BCID2 Control Panel M416 Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed Quality Control Material for Clinical Microbiology Assays Regulatory Class: Class II Product Code: PMN Dated: December 30, 2019 Received: January 2, 2020

Dear Joan Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kristian Roth, Ph.D. Branch Chief Bacterial Multiplex and Medical Counter Measures Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200010

Device Name

FilmArray BCID2 Control Panel M416

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a combination of maroon and yellow colors. The word "MAINE MOLECULAR QUALITY CONTROLS, INC." is written in smaller font below the letters. A yellow abstract design is placed to the left of the letters.

23 Mill Brook Road Saco, Maine 04072 www.mmaci.com hone: 207-885-1072 Fax: 207-885-1079

Section 5: 510 (k) Summary

510(k) Number:

Purpose for submission: New product

Applicant Information:

Applicant:	Maine Molecular Quality Controls, Inc.
Address:	23 Mill Brook RoadSaco, Maine 04072

Contact Person:	Joan Gordon, President MMQCI
Phone:	207-885-1072 extension 201
Fax:	207-885-1079
Email Address:	jgordon@mmqci.com

Preparation Date: December 30, 2019

Device

Device Trade Name:	FilmArray BCID2 Control Panel M416, P/N M416
Device Common Name:	Quality Control Material for Microbiology Assays
Device Type:	Assayed quality control material for clinical microbiology assays
Class:	Class II (Special controls)
Regulation:	21 CFR 866.3920
Panel:	Microbiology - 83
Product code:	PMN

Predicate Device

K190222; FilmArray Pneumonia/Pneumoniaplus Control, Maine Molecular Quality Controls, Inc.

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a combination of maroon and yellow. To the left of the letters is a stylized graphic in yellow, resembling a brush stroke or a flowing ribbon. Below the letters, the full name of the company, "MAINE MOLECULAR QUALITY CONTROLS, INC.," is written in smaller font.

obtained from individuals suspected of sepsis. Each tube of contains sufficient liquid for a single use.

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	Proteus spp.
Enteric bacteria	Salmonella spp
Enterobacter cloacae complex	Serratia marcescens
Escherichia coli	Haemophilus influenzae
Klebsiella aerogenes	Neisseria meningitidis
Klebsiella oxytoca	Pseudomonas aeruginosa
Klebsiella pneumoniae group	Stenotrophomonas maltophilia
Yeast
Candida albicans	Candida parapsilosis
Candida auris	Candida tropicalis
Candida glabrata	Cryptococcus neoformans/gattii
Candida krusei

Table 1. Pathogens and antimicrobial resistance genes found in FilmArray BCID2 Control Panel M416, detected by BioFire BCID2 Panel assay.

Device Intended Use

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Image /page/5/Picture/0 description: The image shows the logo for Maine Molecular Quality Controls, Inc. (MMQCI). The logo features the letters "MMQCI" in a bold, serif font, with "MM" in a dark red color and "QCI" in a lighter shade of red. Below the letters, there is the text "MAINE MOLECULAR QUALITY CONTROLS, INC." in a smaller, sans-serif font. To the left of the letters, there is an abstract, curved design in a yellow color, which appears to be a stylized representation of a wave or ribbon.

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 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.

Characteristic	Candidate Device:FilmArray BCID2 ControlPanel M416	Predicate Device:FilmArrayPneumonia/PneumoniaplusControl (K190222)
Intended Use	External assayed qualitycontrol to monitor in vitrolab nucleic acid test	Same
Physical format	Ready-to-Use Liquid	Same
Directions for Use	Process like patient sample(Pipette from blood culturetube)	Process like patient sample(Pipette from sputum or BALtube)
Composition	Synthetic DNA	Synthetic DNA, and RNAtranscripts
Assay Steps Monitored	Amplification, detection,identification	Same plus reversetranscription
Number of targetsmonitored in one assay	Multiple, >30 targets	Same, >30 targets

Substantial Equivalence

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Image /page/6/Picture/0 description: The image shows the logo for MMQCI, which stands for Maine Molecular Quality Controls, Inc. The logo features the letters "MMQCI" in a serif font, with "MM" in a dark red color and "QCI" in black. Below the letters, the full name of the company is written in a smaller font. A golden, abstract brushstroke-like design is placed to the left of the letters, adding a decorative element to the logo.

Summary Performance Data

Precision: Reproducibility Testing Summary of Internal and External sites

Three lots of FilmArray BCID2 Control Panel M416 consisting of FilmArray BCID2 Positive Control and FilmArray BCID2 Negative Control were manufactured by MMQCI. Reproducibility studies were performed by testing the 3 control lots with the BioFire BCID2 Panel assay on FilmArray systems at MMQCI and 3 clinical laboratories. The lots were manufactured and tested such that routine variables including multiple lots of key manufacturing components, different operators, pouch lots, instruments, test sites, and testing over time were incorporated in the study.

Internal testing at MMQCI (Saco, Maine) was performed by testing 20 samples of each of the 3 lots on different days over approximately 6 weeks, with 3 pouch lots by 4 operators for a total of 122 (2 repeats) tests.

The external performance study to assess the FilmArray BCID2 Control Panel M416 in a clinical setting was performed by testing 10 samples of each of the 3 lots of BCID2 Control Panel M416 on different days at 3 CLIA-certified clinical sites using 3 FilmArray pouch lots and incorporating multiple operators for a total of 186 (6 repeats) tests.

Summary Results and Conclusions:

Of the total 307 tests performed for the Reproducibility study, there were 300 correct results, positive and negative as listed in Table 2. There were 2 Invalid results and 5 incorrect Positive control results. The samples that gave Invalid results were re-tested according to BioFire instructions and were not included in the Percent Correct analysis in the table below. The incorrect Positive controls were all correct upon retesting. The predetermined acceptance criteria for the FilmArray BCID2 Control Panel M416 Reproducibility study, internal and external, were met for an overall correct result rate of 98.4%.

TotalTests	Invalid*	CorrectPositiveControlResult	IncorrectPositiveControlResult	PercentCorrectPositiveControl	CorrectNegativeControlResult	IncorrectNegativeControlResult	PercentCorrectNegativeControl	TotalPercentCorrect
Summary of Reproducibility Test Results at MMQCI and 3 Clinical Laboratory Sites
307	2	150	5	96.8%	150	0	100.0%	98.4%

Table 2. FilmArray BCID2 Control Panel M416: Reproducibility results, all sites.

*The 2 Invalid samples were re-tested according to BioFire instructions and were not included in the Percent Correct analysis.

Regulation Number and Section

§ 866.3920 Assayed quality control material for clinical microbiology assays.

(a)
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.(b)
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.”