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

AI/ML Overview

The provided FDA 510(k) clearance letter and summary discuss the validation of the FilmArray GI Control Panel M238. This device is an assayed quality control material, not an AI/ML-driven diagnostic device. Therefore, many of the requested elements the prompt is asking for (e.g., number of experts, adjudication methods, MRMC study, training sets, human-in-the-loop performance) are not applicable to this type of device.

However, I can extract and present the relevant information regarding its acceptance criteria and the study that proves it meets those criteria, focusing on the concepts applicable to quality control materials:

Device: FilmArray® GI Control Panel M238 (M238)

This device is an external positive and negative assayed quality control used to monitor the performance of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel and the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid assays. It contains synthetic RNA transcripts as targets.

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a quality control material like this is its ability to consistently produce the correct expected results (either positive or negative depending on the specific control) when tested with the target assay. The study demonstrated 100% correctness across all valid tests.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Consistency and Accuracy: The device must consistently yield the expected positive or negative results for the targets it is designed to control, ensuring reliable monitoring of the BIOFIRE FILMARRAY GI Panel and GI Panel Mid assays. This implies a very high percentage of correct results.	100% correct results were observed for both M239 (positive control) and M240 (negative control) across all valid tests (165 total tests). This demonstrates robust and accurate performance.
Validity Rate: A low invalid rate for the quality control material itself when run on the specified system.	0 invalid results out of 165 total tests, indicating high reliability and compatibility with the BIOFIRE FILMARRAY systems.
Reproducibility: Consistent performance across different lots, sites, operators, instruments, and reagent lots.	The study was conducted using 6 control lots, 2 testing sites, 20 unique BIOFIRE FILMARRAY GI Panel reagent lots, 9 operators, and multiple instruments over several months, all yielding 100% correct results. This confirms high reproducibility.

Study Details Proving Acceptance Criteria are Met

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: A total of 165 samples were tested.
* 79 samples of FilmArray GI Control M239 (positive control)
* 86 samples of FilmArray GI Control M240 (negative control)
* Data Provenance: The device was manufactured at MMQCI's facility in Saco, Maine, and tested at 2 unspecified sites. The study was prospective in nature, as it involved the creation and testing of new control lots specifically for this submission. The country of origin of the data is implicitly the USA, given the FDA filing and US company address.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
* Not applicable in the conventional sense for a quality control material. The "ground truth" for a quality control material is its pre-defined composition, meaning it is designed to contain specific targets (for the positive control) or no targets (for the negative control). The BIOFIRE FILMARRAY GI Panel itself serves as the reference against which the control material's behavior is assessed.
* The study involved 9 operators, who presumably were trained laboratory personnel using the BIOFIRE FILMARRAY system according to its Instructions for Use. Their role was in executing the tests, not in establishing a medical "ground truth" through expert review as would be the case for image-based diagnostic AI.

3. Adjudication Method for the Test Set:
* Not applicable. The results are qualitative (Positive/Negative for specific targets, or Valid/Invalid run) and are determined by the automated output of the BIOFIRE FILMARRAY system. There is no subjective interpretation requiring adjudication among experts. The "adjudication" is purely objective: did the control material yield the expected automated result on the instrument?

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret patient cases. This device is a quality control material for an in vitro diagnostic (IVD) assay, not a diagnostic imaging device, nor does it involve human interpretation of complex medical cases. The study demonstrated the device's ability to monitor the performance of the BIOFIRE FILMARRAY system itself.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* This question is more relevant to AI/ML software. In the context of this quality control material, its "standalone" performance refers to its ability to elicit the expected results from the BIOFIRE FILMARRAY system independently. The study demonstrates this functional performance, showing 100% correct results triggered by the control material when used with the instrument, which is the equivalent of "standalone" functionality for this type of product.

6. The Type of Ground Truth Used:
* Defined Composition: For quality control materials, the ground truth is the known, pre-defined composition of the control panel itself. The M239 control is designed to be positive for certain targets, and the M240 control is designed to be negative or non-reactive. The "correctness" is therefore a measure of whether the BIOFIRE FILMARRAY system, when challenged with these known controls, reports the expected results.

7. The Sample Size for the Training Set:
* Not applicable. This is a quality control material, not an AI/ML algorithm that requires a training set. The "training" for such a product implicitly involves its manufacturing and formulation process to achieve the desired composition and stability.

8. How the Ground Truth for the Training Set was Established:
* Not applicable, as there is no training set in the context of an AI/ML algorithm. For the manufacturing of the quality control material, the "ground truth" is established by the precise formulation and characterization of the synthetic RNA transcripts and other components to ensure the desired positive or negative reactivity.

Summary

FDA 510(k) Clearance Letter - FilmArray GI Control Panel M238

Page 1

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

Doc ID # 04017.08.00

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"

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K251526 - Joan Gordon Page 2

(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K251526 - Joan Gordon Page 3

Sincerely,

Bryan M. Grabias -S [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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K251526
FilmArray® GI Control Panel M238 (M238)

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K251526

Device Name
FilmArray® GI Control Panel M238 (M238)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/23) Page 1 of 1

Page 5

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: 207-885-1072
Email Address: jgordon@mmqci.com
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

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

Page 1 of 6

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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

Page 2 of 6

Page 7

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	K251526 (Candidate)	K202196 (Predicate)
	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

Page 3 of 6

Page 8

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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Page 9

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	K251526 (Candidate)	K202196 (Predicate)
	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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Page 10

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 FIMARRAY 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	Correct M239 Control Results	Percent Correct M239 Control	Correct M240 Control Results	Percent Correct M240 Control	Total Percent Correct
1	40	20	100%	20	100%	100%
2	125	59	100%	66	100%	100%
Total	165	79	100%	86	100%	100%

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

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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.”