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

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-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

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K251526

B Applicant

Maine Molecular Quality Controls, Inc.

C Proprietary and Established Names

FilmArray GI Control Panel M238

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 GI Control Panel M238.

B Measurand:

Multi-analyte quality control materials

C Type of Test:

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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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.

## Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) 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-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.

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

Rx - For Prescription Use Only

### D Special Instrument Requirements:

For use on the BIOFIRE FILMARRAY Torch and BIOFIRE FILMARRAY 2.0 instrument systems

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# IV Device/System Characteristics:

# A Device Description:

FilmArray GI Control Panel M238, is a quality control panel consisting of 2 single use, ready-to-use, liquid controls, FilmArray GI Control M239 and FilmArray GI Control 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 provided with the FilmArray GI Control Panel M238 is processed separately according to the manufacturer's Instructions for Use for testing patient samples on both the BIOFIRE FILMARRAY GI Panel and BIOFIRE FILMARRAY GI Panel Mid assays.

The FilmArray GI Control Panel M238 is intended for use as external positive and negative quality controls to monitor the detection and identification of the GI pathogens detected by BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (Table 1), and BIOFIRE FILMARRAY GI Panel Mid (Table 2).

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 | |

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| 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 |

When used together, both tubes detect all the organisms detected by BIOFIRE GI Panel and the BIOFIRE GI Panel Mid assays. Since there is no overlap of organisms between M239 and M240, each tube may serve as negative control for the organisms contained in the other tube.

The synthetic RNA contained in controls M239 and M240 is specifically designed for and intended to be used solely with the BIOFIRE GI Panel and the BIOFIRE GI Panel Mid on the BIOFIRE FILMARRAY Torch and the BIOFIRE FILMARRAY Systems.

Table 3. FilmArray GI Control Panel M238 Contents

| FilmArray GI Control M239 | FilmArray GI Control M240 |
| --- | --- |
| E.coli 0157 | Astrovirus |
| Enteroaggregative E. coli (EAEC) | Campylobacter 1 |
| Shiga-like toxin-producing E. coli (STEC) stx1/stx 2 | Enteropathogenic E. coli (EPEC) |
| Sapovirus (Genogroups I, II, IV, and V) | Enterotoxigenic E. coli (ETEC) lt/st 2 |
| Shigella/Enteroinvasive E. coli (EIEC) | Giardia lamblia |
| Cryptosporidium 1 | Salmonella |
| Clostridium difficile (toxin A/B) | Campylobacter 2 |
| Vibrio cholerae | Enterotoxigenic E. coli (ETEC) lt/st 1 |
| Adenovirus F 40/41 | Cyclospora cayetanensis |
| Vibrio | Enterotoxigenic E. coli (ETEC) lt/st 3 |
| Plesiomonas shigelloides | Entamoeba histolytica |
| Cryptosporidium 1 | Enterotoxigenic E. coli (ETEC) lt/st 3 |
| Yersinia enterocolitica | Rotavirus A 1 |
| | Rotavirus A 2 |
| | Norovirus GI/GII 1 |
| | Norovirus GI/GII 2 |

## B Principle of Operation:

Each liquid control provided with the FilmArray GI Control Panel M238 is processed separately according to the manufacturer's Instructions for Use for testing patient samples on both the BIOFIRE FILMARRAY GI Panel and BIOFIRE FILMARRAY GI Panel Mid assays. Results are reported automatically by the FilmArray GI Control Panel M238 Software as either "Detected", "Undetected" or "INVALID [failure reason]".

## V Substantial Equivalence Information:

## A Predicate Device Name(s):

BioFire RP2.1/RP2.1plus Control Panel M441

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B Predicate 510(k) Number(s):

K202196

# C Comparison with Predicate(s):

| Device & Predicate Device(s): | K251526 | K202196 |
| --- | --- | --- |
| 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 (Clostridioides) difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), | BioFire RP2.1/RP2.1plus Control Panel M441 is intended for use as an external positive and negative assayed quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Adenovirus, Coronavirus, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H1-2009, Influenza A subtype H3, Influenza B, Middle East Respiratory Syndrome Coronavirus, Parainfluenza Virus, Respiratory Syncytial Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma pneumoniae on the BIOFIRE Respiratory |

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| Device & Predicate Device(s): | K251526 | K202196 |
| --- | --- | --- |
| | 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. | 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. |
| Physical format | Ready-to-Use Liquid | Same |
| Directions for Use | Process like patient sample | Same |

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

VI Standards/Guidance Documents Referenced:

None referenced

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Reproducibility

A reproducibility study was conducted at two sites with the BIOFIRE FILMARRAY GI Panel on BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch systems. Testing included evaluation of seventy-nine (79) samples of FilmArray GI Control M239 and eighty-six (86) samples of FilmArray GI Control M240 with six lots each on different days across two sites using 20 unique BIOFIRE FILMARRAY GI Panel pouch lots and incorporating 9 operators and multiple instruments, for a total of 165 tests.

Of the 165 samples tested, the correct analytes were detected (for positive controls) or not detected (for negative controls) resulting in a correct call rate of 100% (Table 4).

Table 4: 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 (95% CI) | Correct M240 Results | Incorrect M240 Results | Percent Correct M240 (95% CI) | 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% (95.3% - 100%) | 86 | 0 | 100% (95.7% -100%) | 100% |

Within-run precision (Repeatability)

Two lot each of FilmArray GI Control M239 and FilmArray GI Control M240 were tested six times on two pouch lot, by the same operator and on the same day to demonstrate within-run precision on the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

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Table 5. Summary of Within-run Precision for FilmArray GI Control Panel M238

| Control | Control Lot # | Number of Tests | Correct Results |
| --- | --- | --- | --- |
| FilmArray GI Control M239 | C08JAN21B | 6 | 6/6 |
| FilmArray GI Control M239 | H11NOV21C | 6 | 6/6 |
| FilmArray GI Control M240 | F12JAN21B | 6 | 6/6 |
| FilmArray GI Control M240 | A16NOV21B | 6 | 6/6 |

Lot-to-Lot precision

A subset of the reproducibility data generated from the 125 samples of FilmArray GI Control Panel M238 tested at MMQCI was analyzed to demonstrate lot-to-lot variability. Data for 7 samples each of FilmArray GI Control M239 and FilmArray GI Control M240 were analyzed for reproducibility with one pouch lot on 1 BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch instrument at a single site (MMQCI) with 2 operators.

Table 6. Summary of FilmArray GI Control M239 and FilmArray GI Control M240 Lot-to-Lot Testing

| Control | Control Lot # | Number of Tests | Correct Results |
| --- | --- | --- | --- |
| FILMARRAY GI M239 | E14AUG23B | 7 | 7/7 |
| FILMARRAY GI M239 | B01FEB24D | 7 | 7/7 |
| FILMARRAY GI M240 | A15AUG23F | 7 | 7/7 |
| FILMARRAY GI M240 | C02FEB24C | 7 | 7/7 |

A Cp data analysis was also conducted for the precision study results and no significant difference in the mean Cp values was observed based on testing of FilmArray GI Control Panel M238 lots on different days by multiple operators at external and internal sites. The reproducibility and precision studies evaluating the FilmArray GI Control Panel M238 are acceptable.

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

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Not applicable because the FilmArray GI Control Panel M238 is packaged for single use.

## Closed Vial Real-time Stability

A closed vial real-time stability study was conducted for the FilmArray GI Control Panel M238 which tested three lots each of FilmArray GI Control M239 and FilmArray GI Control M240 stored at -25 to -15 °C up to 112 months. The real-time stability study for the FilmArray GI Control Panel M238 supports a shelf-life of 36 months under the chosen storage conditions (-25 to -15 °C).

## Shipping Stability

A shipping study conducted for the FilmArray GI Control Panel M238 evaluated performance for shipping conditions at frozen -25° to -15°C. One lot each of FilmArray GI Control M239 and FilmArray GI Control M240 were packed for shipping according to dry ice shipping instructions for a simulated 5-day delivery followed by simulating shipping/receiving condition. Testing was performed in duplicate with BIOFIRE FILMARRAY GI Panel on the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch systems. Simulated shipping studies for the FilmArray GI Control Panel M238 support shipping under dry ice conditions.

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 GI Control Panel M238 is synthetic. To investigate the potential effects of the synthetic matrix on the BIOFIRE FILMARRAY GI Panel assay, equal volumes of the same concentration of Inactivated Salmonella enterica pathogen (acquired from a commercial vendor) were spiked into 270μL of FilmArray GI Control M239 and 270μL of stool in Cary Blair transport media, followed by testing with the BIOFIRE GI Panel assay on the BIOFIRE FILMARRAY 2.0 and BIOFIRE FILMARRAY Torch systems in triplicates. The acceptance criteria were correct results for all spiked stool and spiked synthetic matrix samples.

Positive expected calls were obtained for the spiked simulated clinical sample and spiked FilmArray GI Control M239 (Detected for Salmonella enterica). No inhibition was observed

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for the inactivated Salmonella enterica spiked into either the synthetic matrix or in the Cary Blair transport media.

The results indicated that the FilmArray GI Control Panel M238 matrix has no effect on the assay.

## 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.

## D Clinical Cut-Off:

Not applicable.

## E Expected Values/Reference Range:

FilmArray GI Panel M238 is a qualitative control and the expected results in the results for BIOFIRE FILMARRAY GI panel and the BIOFIRE FILMARRAY GI Panel Mid are listed in the tables below.

Table 7: BIOFIRE FILMARRAY GI Panel Result Summary

| Target | M239 Call | M240 Call |
| --- | --- | --- |
| Bacteria | | |
| Campylobacter | Not Detected | Detected |
| Clostridium difficile toxin A/B | Detected | Not Detected |
| Plesiomonas shigelloides | Detected | Not Detected |
| Salmonella | Not Detected | Detected |
| Vibrio | Detected | Not Detected |
| Vibrio cholerae | Detected | Not Detected |
| Yersinia enterocolitica | Detected | Not Detected |
| Diarrheagenic E. coli/Shigella | | |
| Enteroaggregative E. coli (EAEC) | Detected | Not Detected |
| Enteropathogenic E. coli (EPEC) | NA* | Detected |
| Enterotoxigenic E. coli (ETEC) lt/st | Not Detected | Detected |

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| Target | M239 Call | M240 Call |
| --- | --- | --- |
| Shiga-like toxin-producing E. coli (STEC) stx1/stx2 | Detected | Not Detected |
| E. coli O157 | Detected | NA** |
| Shigella/Enteroinvasive E. coli (EIEC) | Detected | Not Detected |
| Parasites | | |
| Cryptosporidium | Detected | Not Detected |
| Cyclospora cayetanensis | Not Detected | Detected |
| Entamoeba histolytica | Not Detected | Detected |
| Giardia lamblia | Not Detected | Detected |
| Viruses | | |
| Adenovirus F 40/41 | Detected | Not Detected |
| Astrovirus | Not Detected | Detected |
| Norovirus GI/GII | Not Detected | Detected |
| Rotavirus A | Not Detected | Detected |
| Sapovirus | Detected | Not Detected |

* EPEC will be reported as N/A (Not Applicable) regardless of the EPEC assay result when STEC is detected.
** E. coli O157 will be reported as N/A (Not Applicable) when STEC is not detected.

Table 8: BIOFIRE FILMARRAY GI Panel Mid Result Summary

| Target | M239 Call | M240 Call |
| --- | --- | --- |
| Bacteria | | |
| Campylobacter (C. jejuni/C. coli/C. upsaliensis) | Not Detected | Detected |
| Clostridioides (Clostridium) difficile (toxin A/B) | Detected | Not Detected |
| Salmonella | Not Detected | Detected |
| Shiga-like toxin-producing E. coli (STEC) stx1/stx2 | Detected | Not Detected |
| Shigella/Enteroinvasive E. coli (EIEC) | Detected | Not Detected |
| Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae) | Detected | Not Detected |
| Yersinia enterocolitica | Detected | Not Detected |
| Parasites | | |
| Cryptosporidium | Detected | Not Detected |
| Cyclospora cayetanensis | Not Detected | Detected |
| Giardia lamblia | Not Detected | Detected |
| Viruses | | |
| Norovirus GI/GII | Not Detected | Detected |

# VIII Proposed Labeling:

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

# IX Conclusion:

K251526 - Page 12 of 13

{12}

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

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