FilmArray GI Control Panel M238

K251526 · Maine Molecular Quality Controls, Inc. · PMN · Aug 14, 2025 · Microbiology

Device Facts

• Record ID: K251526
• Device Name: FilmArray GI Control Panel M238
• Applicant: Maine Molecular Quality Controls, Inc.
• Product Code: PMN · Microbiology
• Decision Date: Aug 14, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Intended Use

The FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on the BIOFIRE FILMARRAY systems. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays qualitatively detect the following targets: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. The FilmArray GI Control Panel M238 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE FILMARRAY GI Panel and the BIOFIRE FILMARRAY GI Panel Mid assays. This product is not intended to replace manufacturer internal controls provided with these devices.

Device Story

FilmArray GI Control Panel M238 consists of two single-use, ready-to-use liquid controls (M239, M240) containing synthetic RNA transcripts of GI pathogens; used as external positive/negative controls for BIOFIRE FILMARRAY GI Panel and GI Panel Mid assays. Controls are processed like patient samples on BIOFIRE FILMARRAY Torch or 2.0 systems. System performs reverse transcription, amplification, and detection; software automatically reports results as 'Detected', 'Undetected', or 'INVALID'. Healthcare providers use output to verify assay performance and monitor system integrity. Benefits include ensuring accurate diagnostic testing for gastrointestinal pathogens.

Clinical Evidence

Bench testing only. Study evaluated 165 samples (79 M239, 86 M240) across 2 sites using 20 reagent lots, 9 operators, and multiple BIOFIRE FILMARRAY 2.0/Torch systems. Results showed 100% (165/165) correct performance with no invalid results, confirming robust reproducibility.

Technological Characteristics

Ready-to-use liquid control; synthetic RNA transcripts in non-infectious buffer/preservative solution. Single-use format. Designed for use on BIOFIRE FILMARRAY 2.0 and Torch systems. Monitors reverse transcription, amplification, and detection steps of nucleic acid assays.

Indications for Use

Indicated for use as external positive and negative assayed quality control to monitor performance of BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and GI Panel Mid assays on BIOFIRE FILMARRAY systems. For prescription use only.

Regulatory Classification

Identification

An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.

Special Controls

An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; (ii) Expected values; (iii) Analyte source; (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays; (C) Stating if the material is a surrogate control; and (D) The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.” (iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”

Predicate Devices

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

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 14, 2025

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

Re: K251526
Trade/Device Name: FilmArray GI Control Panel M238
Regulation Number: 21 CFR 866.3920
Regulation Name: Assayed Quality Control Material For Clinical Microbiology Assays
Regulatory Class: Class II
Product Code: PMN
Dated: May 16, 2025
Received: May 19, 2025

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251526 - Joan Gordon
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K251526 - Joan Gordon
Page 3

Sincerely,

Bryan M. Digitally signed by Bryan M. Grabias -S
Date: 2025.08.14 09:27:26 -04'00'

Bryan Grabias, Ph.D.
Acting Branch Chief
Bacterial Respiratory and Medical Countermeasures Branch
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K251526

Device Name
FilmArray® GI Control Panel M238 (M238)

Indications for Use (Describe)
The FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on the BIOFIRE FILMARRAY systems. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays qualitatively detect the following targets: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. The FilmArray GI Control Panel M238 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE FILMARRAY GI Panel and the BIOFIRE FILMARRAY GI Panel Mid assays. This product is not intended to replace manufacturer internal controls provided with these devices.

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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510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

510(k) Number: K251526

Applicant Information:

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

Contact Person: Joan Gordon, President, MMQCI
Phone: [phone]
Email Address: [e-mail]

Preparation Date: August 1, 2025

Device

Device Trade Name: FilmArray® GI Control Panel M238 (M238)
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
Product code: PMN

Predicate Device

K202196; BioFire® RP2.1/RP2.1plus Control Panel

Device Description

FilmArray GI Control Panel M238, P/N M238, is a quality control panel consisting of 2 single use, ready-to-use, liquid controls, FilmArray GI Control M239, P/N M239, and FilmArray GI Control M240, P/N M240. Each kit of FilmArray GI Control Panel M238 is comprised of 6 tubes of M239 and 6 tubes of M240. Together the 2 controls contain synthetic RNA corresponding to genome segments of all the pathogens detected by the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and BIOFIRE FILMARRAY GI Panel Mid assays, suspended in a non-infectious solution of buffers, preservatives and stabilizers.

Each liquid control of FilmArray GI Control Panel M238 is processed separately according to the BIOFIRE GI Panel and BIOFIRE GI Panel Mid manufacturer’s Instructions for Use for patient

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samples, stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

Table 1. Bacteria, Viruses, and Parasites Detected by the BIOFIRE FILMARRAY GI Panel

| Bacteria | Viruses |
| --- | --- |
| Campylobacter (C. jejuni/C. coli/ C. upsaliensis) | Adenovirus F 40/41 |
| Clostridium difficile (toxin A/B) | Astrovirus |
| Plesiomonas shigelloides | Norovirus GI/GII |
| Salmonella | Rotavirus A |
| Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae) | Sapovirus (Genogroups I, II, IV, and V) |
| V. cholerae | |
| Yersinia enterocolitica | |
| Diarrheagenic E. coli/Shigella | Parasites |
| Enteroaggregative E. coli (EAEC) | Cryptosporidium |
| Enteropathogenic E. coli (EPEC) | Cyclospora cayetanensis |
| Enterotoxigenic E. coli (ETEC) lt/st | Entamoeba histolytica |
| Shiga-like toxin-producing E. coli (STEC) stx1/stx2 | Giardia lamblia |
| E. coli O157 | |
| Shigella/Enteroinvasive E. coli (EIEC) | |

Table 2. Bacteria, Viruses, and Parasites Detected by the BIOFIRE FILMARRAY GI Panel Mid

| Bacteria | Viruses |
| --- | --- |
| Campylobacter (C. jejuni/C. coli/ C. upsaliensis) | Norovirus GI/GII |
| Clostridioides (Clostridium) difficile (toxin A/B) | |
| Salmonella | |
| Shiga-like toxin-producing E. coli (STEC) stx1/stx2 | Parasites |
| Shigella/Enteroinvasive E. coli (EIEC) | Cryptosporidium |
| Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae) | Cyclospora cayetanensis |
| Yersinia enterocolitica | Giardia lamblia |

# Intended Use/Indications for Use

The FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on the BIOFIRE FILMARRAY systems. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays qualitatively detect the following targets: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-

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producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. The FilmArray GI Control Panel M238 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE FILMARRAY GI Panel and the BIOFIRE FILMARRAY GI Panel Mid assays. This product is not intended to replace manufacturer internal controls provided with these devices.

## Comparison With Predicate

| Device & Predicate Device(s): | K251526 (Candidate) | K202196 (Predicate) |
| --- | --- | --- |
| Device Trade Name | FilmArray GI Control Panel M238 | BioFire RP2.1/RP2.1plus Control Panel M441 |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The FilmArray GI Control Panel M238 is intended for use as an external positive and negative assayed quality control to monitor performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays on the BIOFIRE FILMARRAY systems. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays qualitatively detect the following targets: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium | 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 |

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| Device & Predicate Device(s): | K251526 (Candidate) | K202196 (Predicate) |
| --- | --- | --- |
| | (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative_E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, and Sapovirus. The FilmArray GI Control Panel M238 contains synthetic RNA transcripts in stabilizing solution, buffers, and preservatives. The FilmArray GI Control Panel M238 is designed for and intended to be used solely with the BIOFIRE FILMARRAY GI Panel and the BIOFIRE FILMARRAY GI Panel Mid assays. This product is not intended to replace manufacturer internal controls | 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) assay performed on the 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 assay. This product is not intended to replace manufacturer controls provided with the device. |

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| Device & Predicate Device(s): | K251526 (Candidate) | K202196 (Predicate) |
| --- | --- | --- |
| | provided with these devices. | |
| Physical format | Ready-to-Use Liquid | Same |
| Directions for Use | Process like patient sample | Same |
| Composition | Synthetic RNA transcripts suspended in a non-infectious solution of buffers, preservatives and stabilizers. | Same |
| Assay steps monitored | Reverse transcription, amplification, detection, identification | Same |
| Test System | BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch | Same |
| General Device Characteristic Differences | | |
| Targets | Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus | 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 |

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| Device & Predicate Device(s): | K251526 (Candidate) | K202196 (Predicate) |
| --- | --- | --- |
| | GI/GII, Rotavirus A, and Sapovirus | |
| Number of pathogen targets monitored simultaneously in one assay | 22 | 23 |

## Standard/Special Control/Guidance Document Referenced (if applicable):

21 CFR 866.3920 Assayed quality control material for clinical microbiology assays

## Summary Performance Data

Six lots each of FilmArray GI Control M239 and FilmArray GI Control M240 were manufactured by MMQCI at MMQCI’s facility in Saco, Maine. All testing of the FilmArray GI Control Panel M238 was performed using BIOFIRE FILMARRAY Gastrointestinal (GI) Panel assay on the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems. Seventy-nine (79) samples of FilmArray GI Control M239 and eighty-six (86) samples of FilmArray GI Control M240 were tested at 2 sites, for a total of 165 tests, using 20 unique BIOFIRE FILMARRAY GI Panel reagent lots, incorporating 9 operators and multiple instruments, over several months.

## Results and Conclusions:

Of the 165 samples tested, all 165 results were valid and 100% correct. Test results demonstrate robust performance across 2 testing sites, using multiple test reagent lots, instruments and operators, confirming that FilmArray GI Control Panel M238 performs as well as, and is as effective and safe as, the predicate device, BIOFIRE RP2.1/RP2.1plus Control Panel M441 (K202196), therefore supporting substantial equivalence to that device.

## Summary of Reproducibility Study Results for 6 Control Lots at 2 Sites

| Summary of Performance Data for FilmArray GI Control Panel M238 | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Site | Total Tests | Invalid | Correct M239 Control Results | Incorrect M239 Control Results | Percent Correct M239 Control | Correct M240 Control Results | Incorrect M240 Control Results | Percent Correct M240 Control | Total Percent Correct |
| 1 | 40 | 0 | 20 | 0 | 100% | 20 | 0 | 100% | 100% |
| 2 | 125 | 0 | 59 | 0 | 100% | 66 | 0 | 100% | 100% |
| Total | 165 | 0 | 79 | 0 | 100% | 86 | 0 | 100% | 100% |

FilmArray GI Control Panel M238 performance is substantially equivalent to predicate device, BioFire RP2.1/RP2.1plus Control Panel M441 (K202196).