BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

K243885 · Biofire Diagnostics, LLC · PCH · Jan 16, 2025 · Microbiology

Device Facts

• Record ID: K243885
• Device Name: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
• Applicant: Biofire Diagnostics, LLC
• Product Code: PCH · Microbiology
• Decision Date: Jan 16, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3990
• Device Class: Class 2

Indications for Use

The BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid is an automated qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE® FILMARRAY® Systems. The BIOFIRE FILMARRAY GI Panel Mid is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria, parasites, and viruses are identified using the BIOFIRE FILMARRAY GI Panel Mid: Campylobacter (C. jejuni/C. coli/ C. upsaliensis), Clostridioides (Clostridium) difficile (toxin A/B), Salmonella, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, Shigella/Enteroinvasive E. coli (EIEC), Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), Yersinia enterocolitica, Cryptosporidium, Cyclospora cayetanensis, Giardia lamblia (also known as G. intestinalis and G. duodenalis), Norovirus GI/GII. The BIOFIRE FILMARRAY GI Panel Mid is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the BIOFIRE FILMARRAY GI Panel Mid. The agent detected may not be the definite cause of the disease. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. This device is not intended to monitor or guide treatment for C. difficile infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica were established primarily with retrospective clinical specimens. Performance characteristics for Vibrio (V. parahaemolyticus, V. vulnificus, and Vibrio cholerae) was established primarily using contrived clinical specimens. Negative BIOFIRE FILMARRAY GI Panel Mid results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Device Story

Multiplex nucleic acid-based assay; detects 11 gastrointestinal pathogens from stool samples; utilizes BIOFIRE FILMARRAY System; modification of previously cleared BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367); modification involves software masking to report subset of 22 original targets; intended for clinical laboratory use; aids diagnosis of GI infections; results integrated with clinical evaluation and lab findings.

Clinical Evidence

Prospective clinical evaluation (2013) and additional Norovirus data (2023). Sensitivity/PPA ranged from 94.5% to 100% for detected analytes; Specificity/NPA ranged from 96.5% to 100%. Bench testing confirmed LoD (1.0E+02-8.0E+04 CFU/mL for bacteria; 5.0E+01-5.0E+03 units/mL for parasites; 1.0E+04 RNA copies/mL for Norovirus). Reproducibility studies demonstrated high precision across sites, operators, and systems.

Technological Characteristics

Nested multiplex PCR; high-resolution melt curve analysis. Reagents stored in freeze-dried format within disposable pouch. Automated mechanical lysis and magnetic bead purification. Compatible with BIOFIRE 2.0 and TORCH systems. Connectivity: Standalone instrument. Software: Pouch-specific module for automated interpretation.

Indications for Use

Indicated for individuals with signs/symptoms of gastrointestinal infection to detect and identify specific bacteria, viruses, and parasites from stool samples in Cary Blair transport media. Not intended to monitor or guide C. difficile treatment.

Regulatory Classification

Identification

A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Special Controls

*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).

Predicate Devices

• BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel (K242367)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243885

B Applicant

BioFire Diagnostics, LLC

C Proprietary and Established Names

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PCH | Class II | 21 CFR 866.3990 - Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This minor changes to the software and labeling of the previously cleared BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367) was to mask and then report out only 11 of the 22 targets on the BIOFIRE GI Menu. No new performance data were reviewed.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

4. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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