Xpert GI Panel

K251721 · Cepheid · PCH · Jan 16, 2026 · Microbiology

Device Facts

• Record ID: K251721
• Device Name: Xpert GI Panel
• Applicant: Cepheid
• Product Code: PCH · Microbiology
• Decision Date: Jan 16, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3990
• Device Class: Class 2

Indications for Use

The Xpert GI Panel, performed on the GeneXpert® Instrument Systems, is a qualitative multiplexed in vitro diagnostic test that is capable of the simultaneous detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus directly from stool samples in Cary Blair transport media obtained from individuals with signs and symptoms of gastrointestinal infection. The test utilizes automated, qualitative real time polymerase chain reaction (PCR). The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and virus are identified using the Xpert GI Panel: Pathogens Detected: Bacteria: Campylobacter (C. jejuni/C. coli), Shiga toxin-producing Escherichia coli (STEC) stx1/stx2, Salmonella, Shigella/Enteroinvasive Escherichia coli, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae Parasites: Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia), Cryptosporidium Virus: Norovirus GI/GII Pathogens Reported: Bacteria: Campylobacter, STEC stx1, STEC stx2, Salmonella, Shigella EIEC, Yersinia, V. parahaemolyticus, V. cholerae Parasites: Giardia, Cryptosporidium Virus: Norovirus Results are meant to be used in conjunction with other clinical, laboratory and epidemiological data and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out coinfection with pathogens not included in the Xpert GI Panel. The pathogen detected may not be the definite cause of the disease. Negative 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.

Device Story

The Xpert GI Panel is an automated, qualitative in vitro diagnostic test for the simultaneous detection of 11 gastrointestinal pathogens (bacteria, parasites, virus) from stool samples in Cary Blair transport media. The device uses a single-use disposable cartridge containing reagents for sample purification, reverse transcription, and nested real-time PCR amplification. The GeneXpert Instrument System (Dx, Infinity, or Touchscreen) performs hands-off processing, including nucleic acid extraction, amplification, and melt curve analysis. The system measures fluorescent signals and uses embedded algorithms to interpret results as positive or negative for each target. The test is performed in clinical laboratories by trained operators. Results are provided in ≤75 minutes and are intended to be used alongside other clinical, laboratory, and epidemiological data to aid in the diagnosis of gastrointestinal infections. The device benefits patients by providing rapid, multiplexed identification of pathogens, which can inform clinical decision-making and patient management.

Clinical Evidence

Clinical performance was evaluated in a multicenter study (19 sites) using 1,592 prospective fresh stool specimens, 103 pre-selected archived specimens, and 468 contrived samples. Performance was compared to FDA-cleared molecular assays or composite comparators. PPA ranged from 90.7% to 100% for most analytes; NPA was generally >98%. No clinical data for V. parahaemolyticus in prospective samples (0 positives).

Technological Characteristics

Nested multiplex RT-qPCR with melt curve analysis. Uses single-use disposable cartridges with integrated sample processing, nucleic acid extraction, and detection. Includes Sample Processing Control (SPC), Internal Control (IC), and Probe Check Control (PCC). Operates on GeneXpert Instrument Systems (Dx, Infinity, Touchscreen) with 10-color modules. Software-controlled automated analysis.

Indications for Use

Indicated for individuals with signs/symptoms of gastrointestinal infection. Detects/identifies DNA/RNA of specific bacteria, parasites, and viruses directly from stool samples in Cary Blair transport media.

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

• FilmArray Gastrointestinal (GI) Panel (K140407)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number

K251721

B Applicant

Cepheid

C Proprietary and Established Names

Xpert GI Panel

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PCH | Class II | 21 CFR 866.3990 - Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay | Microbiology |
| OOI | Class II | 21 CFR 862.2570 – Instrumentation for Clinical Multiplex Test Systems | CH- Chemistry |

## II Submission/Device Overview:

### A Purpose for Submission:

To obtain a substantial equivalence determination for the Xpert GI Panel performed on GeneXpert Instrument systems.

### B Measurand:

Targeted nucleic acid sequences of the following bacteria, parasites, and viruses:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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Bacteria:
Campylobacter (C. jejuni/C. coli)
Shiga toxin-producing Escherichia coli (STEC) stx1/stx2
Salmonella spp.
Shigella/Enteroinvasive Escherichia coli (shigella EIEC)
Yersinia enterocolitica
Vibrio parahaemolyticus
Vibrio cholerae

Parasites:
Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia)
Cryptosporidium

Virus:
Norovirus GI/GII

C Type of Test:
The Xpert GI panel is performed on the Cepheid GeneXpert Instrument systems equipped with 10-color modules and utilizes automated, qualitative real time polymerase chain reaction (PCR). The Xpert GI Panel simultaneously detects and identifies DNA and RNA from multiple bacteria or parasites as well as Norovirus using reverse transcription real-time polymerase chain reaction (PCR) with a nested PCR set-up. The first PCR involves qualitative reverse transcription followed by PCR, and the second PCR is a real-time PCR. The Xpert GI Panel test results are interpreted by GeneXpert Instrument Systems from measured fluorescent signals and embedded calculation algorithms and will be reported as positive or negative for each of the analytes.

III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

B Indication(s) for Use:
The Xpert GI Panel, performed on the GeneXpert Instrument Systems, is a qualitative multiplexed in vitro diagnostic test that is capable of the simultaneous detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus directly from stool samples in Cary Blair transport media obtained from individuals with signs and symptoms of gastrointestinal infection. The test utilizes automated, qualitative real time polymerase chain reaction (PCR). The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and virus are identified using the Xpert GI Panel:

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| Pathogens Detected | | Pathogens Reported |
| --- | --- | --- |
| Bacteria | Campylobacter (C. jejuni/C. coli) | Campylobacter |
| | Shiga toxin-producing Escherichia coli (STEC) stx1/stx2 | STEC stx1 |
| | | STEC stx2 |
| | Salmonella | Salmonella |
| | Shigella/Enteroinvasive Escherichia coli | Shigella EIEC |
| | Yersinia enterocolitica | Yersinia |
| | Vibrio parahaemolyticus | V. parahaemolyticus |
| | Vibrio cholerae | V. cholerae |
| Parasites | Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia) | Giardia |
| | Cryptosporidium | Cryptosporidium |
| Virus | Norovirus GI/GII | Norovirus |

Results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with pathogens not included in the Xpert GI Panel. The pathogen detected may not be the definite cause of the disease. Negative 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.

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

Rx - For Prescription Use Only

## D Special Instrument Requirements:

The Xpert GI panel is performed on Cepheid GeneXpert Instrument systems equipped with GeneXpert 10 color modules:

- GeneXpert Dx system (software version Dx 6.4 or higher)
- GeneXpert Infinity system (software version Xpertise 7.1 or higher)
- GeneXpert with Touchscreen (software version OS 2.1 or higher)

## IV Device/System Characteristics:

## A Device Description:

The Xpert Gastrointestinal (GI) Panel test, performed on Cepheid GeneXpert Instrument Systems equipped with 10-color modules, is an automated in vitro diagnostic test for qualitative detection and differentiation of eleven (11) pathogens in stool in Cary Blair specimens collected from individuals suspected of gastrointestinal infection. The results from the Xpert GI Panel test will be available in ≤75 mins.

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B Principle of Operation:

The Xpert GI Panel is performed on the Cepheid GeneXpert Instrument Systems equipped with GeneXpert 10-color modules running software version 6.4 and higher (GeneXpert Dx), software version Xpertise 7.1 or higher (GeneXpert Infinity) or software version OS 2.1 or higher (GeneXpert with Touchscreen). The GeneXpert Instrument Systems automate and integrate sample purification, nucleic acid amplification, and detection of the target sequences from clinical specimens using reverse transcription (conversion of RNA template into DNA) followed by real-time polymerase chain reaction (real-time PCR) and melt curve analysis. The systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. Each test requires the use of a single-use disposable GeneXpert cartridge that contains target-specific reagents and carries out the reverse transcription and PCR processes.

The Xpert GI Panel test includes reagents needed: (i) for sample preparation and (ii) to detect the different bacteria, parasites and virus. A Sample Processing Control (SPC), an Internal Control (IC) and a Probe Check Control (PCC) are also included in the cartridge. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability. The IC is present to ensure adequate processing of RNA targets and monitor the presence of inhibitor(s) in the PCR reaction. The SPC is present to control for adequate extraction and processing of the target sequences in the PCR reaction. The SPC also acts as a control for functionality of melt curve analysis.

The Xpert GI Panel test results are interpreted by GeneXpert Instrument Systems from measured fluorescent signals and embedded calculation algorithms and will be reported as positive or negative for each of the targets.

The Xpert GI Panel test is designed for use with stool specimens collected and transferred to Cary Blair medium according to the Cary Blair manufacturer's instructions or institutional guidelines.

The stool sample in Cary Blair medium are mixed thoroughly. The user will then dip a transfer swab (provided) for 5 seconds into the sample and then transfer the inoculated swab into the sample chamber of the Xpert GI Panel cartridge. The user will break the swab by snapping the shaft against the notch in the sample chamber opening leaving the swab tip in the sample chamber and closing the cartridge lid. The Xpert GI Panel cartridge is then loaded onto the GeneXpert instrument, which performs hands-off automated sample processing and real-time PCR for detection of the target DNA/RNA. After the melt curve analysis, software automatically calculates the melt peak temperature and melt peak height of the pathogens detected using melt curve analysis.

C Instrument Description:

1. Instrument Name:

The Xpert GI Panel test is run on the GeneXpert Instrument Systems family which comprises GeneXpert Dx system, GeneXpert System with Touchscreen, and GeneXpert Infinity System. The most recent 510(k) product clearance for the GeneXpert Dx System with GeneXpert Dx software version 6.5 and the GeneXpert System with Touchscreen with Cepheid OS software version 2.1 was K250218. The last 510(k) product clearance for the GeneXpert Infinity System with GeneXpert Infinity Xpertise software version 7.1 was Xpert C. Difficile/EPI (K243730).

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2. Specimen Identification:

Stool in Cary Blair Transport media collected from patients with suspected gastrointestinal infection.

3. Specimen Sampling and Handling:

The stool or rectal swab sample in Cary Blair medium will be mixed thoroughly. The user will then dip a transfer swab (provided) for 5 seconds into the sample and transfer the inoculated swab into the sample chamber of the Xpert GI Panel cartridge. The user will break the swab by snapping the shaft against the notch in the sample chamber opening leaving the swab tip in the sample chamber and closing the cartridge lid. The Xpert GI Panel cartridge is then loaded onto the GeneXpert instrument, which performs hands-off automated sample processing and real-time PCR for detection of the target DNA/RNA.

4. Calibration:

Please refer to K243730 Decision Summary for GeneXpert Infinity Systems Calibration information and K250218 Decision Summary for GeneXpert Dx System and GeneXpert System with Touchscreen calibration information.

5. Quality Control:

Each test includes a Sample Processing Control (SPC), an Internal Control (IC) and a Probe Check Control (PCC).

- Sample Processing Control (SPC)—The SPC is spores of *Bacillus globigii* included in each cartridge to ensure that the sample was processed correctly. The SPC verifies the lysis of hard to lyse pathogens (parasites and bacteria) if the pathogens are present and that sample processing is adequate. Additionally, this control ensures that the PCR reaction conditions (temperature and time) are appropriate for the amplification reaction, and that the PCR reagents are functional. The SPC also acts as a control for functionality of melt curve analysis. The SPC should be positive in a negative sample and can be negative or positive in a positive sample. The SPC passes if it meets the validated acceptance criteria. The test result is INVALID if all targets are reported negative and the SPC does not meet the assigned acceptance criteria.

- Internal Control (IC)—The IC is an Armored RNA that is included in each cartridge to verify adequate processing of the sample. The IC verifies release of RNA from the sample and that the sample processing is adequate. Additionally, this control detects specimen-associated inhibition of the reverse transcription and PCR reactions. The IC should be positive in a negative sample and can be negative or positive in a positive sample. The IC passes if it meets the validated acceptance criteria. The test result is INVALID if all targets are reported negative and the IC does not meet the assigned acceptance criteria.

- Probe Check Control (PCC)—Before the start of the PCR reaction, the GeneXpert System measures the fluorescence signal from the probes to monitor bead rehydration, reaction tube filling, probe integrity, and dye stability. The PCC passes if it meets the assigned acceptance criteria.

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- External Controls—Following good laboratory practice, external controls, not provided in the kit, should be used in accordance with the requirements of local and state accrediting organizations, as applicable.

V Substantial Equivalence Information:

A Predicate Device Name(s):

FilmArray Gastrointestinal (GI) Panel

B Predicate 510(k) Number(s):

K140407

C Comparison with Predicate(s):

| Device & Predicate Device: | K251721 | K140407 |
| --- | --- | --- |
| Device Trade Name | Xpert GI Panel | FilmArray Gastrointestinal (GI) Panel |
| General Device Characteristic Similarities | | |
| Regulation | 21 CFR 866.3990 | Same |
| Product Code | PCH, OOI | Same |
| Intended Use/Indications For Use | The Xpert GI Panel, performed on the GeneXpert Instrument Systems, is a qualitative multiplexed in vitro diagnostic test that is capable of the simultaneous detection and identification of DNA and RNA from multiple bacteria, parasites and/or virus directly from stool samples in Cary Blair transport media obtained from individuals with signs and symptoms of gastrointestinal infection. The test utilizes automated, qualitative real time polymerase chain reaction (PCR). The following bacteria (including several | The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the FilmArray Instrument. The FilmArray GI Panel 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 FilmArray GI Panel is indicated as an aid in the diagnosis of specific |

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| Device & Predicate Device: | K251721 | K140407 |
| --- | --- | --- |
| | diarrheagenic E. coli/Shigella (pathotypes), parasites, and virus are identified using the Xpert GI Panel:

Pathogens Detected:
Bacteria: Campylobacter (C. jejuni/C. coli), Shiga toxin-producing Escherichia coli (STEC) stx1/stx2, Salmonella, Shigella/Enteroinvasive Escherichia coli, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae

Parasites: Giardia (also known as G. intestinalis, G. duodenalis & G. lamblia), Cryptosporidium

Virus: Norovirus GI/GII

Pathogens Reported:
Bacteria: Campylobacter, STEC stx1, STEC stx2, Salmonella, Shigella EIEC, Yersinia, V. parahaemolyticus, V. cholerae

Parasites: Giardia, Cryptosporidium

Virus: Norovirus | agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. The following bacteria (including several diarrheagenic E-coli/Shigella pathotypes), parasites, and viruses are identified using the FilmArray GI Panel:
* Campylobacter (C. jejuni/C. coli/C. upsaliensis)
* Clostridium difficile (C. difficile) toxin A/B
* Plesiomonas shigelloides
* Salmonella
* Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae) including specific identification of Vibrio cholerae
* Yersinia enterocolitica
* Enteroaggregative Escherichia coli (EAEC)
* Enteropathogenic Escherichia coli (EPEC)
* Enterotoxigenic Escherichia coli (ETEC) lt/st
* Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of the E. coli O157 serogroup within STEC) |

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| Device & Predicate Device: | K251721 | K140407 |
| --- | --- | --- |
| | Results are meant to be used in conjunction with other clinical, laboratory and epidemiological data and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Positive results do not rule out co-infection with pathogens not included in the Xpert GI Panel. The pathogen detected may not be the definite cause of the disease. Negative 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. | * Shigella/Enteroinvasive Escherichia coli (FIEC)
* Cryptosporidium
* Cyclospora cayetanensis
* Entamoeba histolytica
* Giardia lamblia (also known as G. intestinalis and G. duodenalis)
* Adenovirus F 40/41
* Astrovirus
* Norovirus GI/GII
* Rotavirus A
* Sapovirus (Genogroups I, II, IV, and V)
Pathogens reported:
Campylobacter
E. coli 0157
Plesiomonas shigelloides
Salmonella
Vibrio and V. cholerae
Yersinia enterocolitica
STEC (stx1/2)
ETEC
EPEC
EIEC/Shigella
EAEC
Adenovirus F 40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus
Clostridium difficile toxin A/B
Cryptosporidium
Giardia lamblia
Cyclospora cayetanensis
Entamoeba histolytica
Positive results do not rule out co-infection with organisms not included in the FilmArray GI Panel. |

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| Device & Predicate Device: | K251721 | K140407 |
| --- | --- | --- |
| | | The agent detected may not be the definite cause of the disease. |
| Specimen Type | Stool samples in Cary Blair transport media | Same |
| Test Format | Single Use | Same |
| Assay Results | Qualitative | Same |
| Time to Result | ≤75 mins | ≤75 mins |
| **General Device Characteristic Differences** | | |
| Organisms Detected | Campylobacter (C. jejuni/C. coli), Shiga toxin-producing Escherichia coli (STEC) stx1 and STEC stx2 (separate callouts), Salmonella, Shigella/Enteroinvasive Escherichia coli, Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae, Giardia, Cryptosporidium, Norovirus GI/GII | Campylobacter species: C. jejuni/C. coli/C. upsaliensis. Clostridioides (Clostridium) difficile (toxin A/B) Salmonella Yersinia enterocolitica Cryptosporidium Giardia lamblia Enterotoxigenic E. coli (ETEC) lt/st Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E. coli O157 callout Shigella/Enteroinvasive E. coli (EIEC) Norovirus Plesiomonas shigelloides. Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), V. cholerae callout Yersinia enterocolitica Adenovirus F40/41, Rotavirus A Astrovirus, Sapovirus (Genogroups I, II, IV, and V), Cyclospora cayetanensis, Entamoeba histolytica, Enteropathogenic E. coli (EPEC), and Enteroaggregative E. |

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| Device & Predicate Device: | K251721 | K140407 |
| --- | --- | --- |
| | | coli (EAEC). |
| Technology/Detection | Nested multiplex real-time reverse transcription polymerase chain reaction (RT-qPCR) with detection by amplification and melt curve analysis. | Nested multiplex RT-PCR followed by high resolution melting analysis to confirm identity of amplified product |
| Internal Control | Sample Processing Control (SPC)
Internal Control (IC)
Probe Check Control (PCC) | Two controls (RNA Process Control and PCR2 Control) are included in each reagent pouch to control for sample processing and both stages of PCR and melt analysis. |
| Instrument Systems | Cepheid GeneXpert Instrument Systems | FilmArray Instrument |
| Software | GeneXpert Dx 6.4 or higher
GeneXpert Infinity Xpertise 7.1 or higher
Cepheid OS 2.1 or higher | BioFire FilmArray Software |

## VI Standards/Guidance Documents Referenced:

### Guidance:

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, November 2, 2015.

### Standards:

| Organization | Title | Type of Use |
| --- | --- | --- |
| ASI AAMI ISO | 14971:2019 Medical Devices – Applications of risk management to medical devices | Declaration of Conformity |
| CLSI | EP12-A2 – User Protocol for Evaluation of Qualitative test performance;
Approved Guideline – Second Edition | General Use |

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| Organization | Title | Type of Use |
| --- | --- | --- |
| CLSI | EP14-A3 Evaluation of Commutability of Processed Samples; Approved Guideline -Third Edition | General Use |
| CLSI | EP15-A3- User verification of Precision and Estimation of Bias; Approved Guideline – Third Edition | General Use |
| CLSI | EP17-A2 – Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, Approved Guideline – Second Edition | General Use |
| CLSI | EP24-A2Assessment of Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline | General Use |
| CLSI | EP25-A – Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline | General Use |
| CLSI | EP05-A3 – Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition | General Use |
| CLSI | EP07 3^{rd} edition – Interference Testing in clinical Chemistry | General Use |
| CLSI | EP09c 3^{rd} Edition – Measurement Procedure Comparison and Bias Estimation Using Patient Samples | General Use |
| CLSI | MM13 2^{nd} Edition – Collection Transport Preparation and Storage of Specimens for Molecular Methods | General Use |
| CLSI | LIS08-A – Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems | General Use |
| IEC | 61326-1 Edition 3.0 2020-10 – Electrical equipment for measurement control and laboratory use – EMC requirements – Part 1: General Requirements | General Use |
| IEC | 61326-2-6 Edition 3.0 2020-10 – Electrical Equipment for Measurement control and laboratory use – EMC requirements – Part 2-6: Particular Requirements – In vitro diagnostic (IVD) medical equipment | General Use |
| ANSI AAMI IEC | 62304:2006/A1:2016 – Medical Devices software – Software life cycle processes | Declaration of conformity |
| ANSI AAMI IEC | 60601-1-2:2014 – Medical electrical equipment – Part 1-2: General | General Use |

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| Organization | Title | Type of Use |
| --- | --- | --- |
| | requirements for basic safety and essential performance | |

## VII Performance Characteristics:

### A Analytical Performance:

1. Precision/Reproducibility:

The reproducibility and precision of the Xpert GI Panel was evaluated in a multicenter blinded study across three sites utilizing a multi-factor nested design consisting of three contrived panels composed of low positive (~1x LoD), moderate positive (~3x LoD), and negative samples. The negative samples were pooled negative clinical stool matrix.

The positive samples were contrived by diluting target pathogen into pooled negative clinical stool matrix across three panels. Testing was conducted to assess reproducibility over days, lots of Xpert GI Panel cartridges, sites, and operators at each site. The percent agreement of the correct results compared to the expected results analyzed by each of the operators across site is shown in Table 1. Additionally, the combined agreement across sites for each sample (% total agreement) and the two-sided Wilson Score confidence intervals (CI) are presented in the last column.

Low and moderate *V. parahaemolyticus* positives were tested fresh within the 4-day window of specimen stability (2 - 8°C) as part of Panel 3. Panel 3 consisted of low and moderate positive V. parahaemolyticus and negative panel members. The results from the study are summarized in Table 1 below. There were no statistically significant differences in the Xpert GI Panel performance between study sites, lots and operators.

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Table 1: Summary of Reproducibility Study Results - % Agreement

| Panel | Sample | Site 1 | | | Site 2 | | | Site 3 | | | % Total Agreement [95% CI] |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | OP 1 | OP2 | Site | OP 1 | OP 2 | Site | OP 1 | OP 2 | Site | |
| Panel 1 | Campylobacter Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 1 | Campylobacter Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 1 | STEC stx2 Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 1 | STEC stx2 Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 1 | Negative | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Salmonella Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 23/23a | 24/24 | 47/47 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Salmonella Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (143/143) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 23/23a | 24/24 | 47/47 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Yersinia Low Pos | 100% | 100% | 100% | 100% | 96% | 98% | 100% | 100% | 100% | 99.3% (143/144) [96.2-99.9] |
| | | 24/24 | 24/24 | 48/48 | 23/23a | 24/24 | 47/47 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Yersinia Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (143/143) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 23/23a | 24/24 | 47/47 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Cryptosporidium Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Cryptosporidium Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (143/143) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 23/23a | 24/24 | 47/47 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Giardia Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Giardia Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Shigella EIEC Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Shigella EIEC Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Norovirus Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Nerovirus Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (144/144) [97.4-100.0] |
| | | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | 24/24 | 24/24 | 48/48 | |
| Panel 2 | Negative | 100% | 96% | 98% | 100% | 96% | 98% | 100% | 100% | 100% | 98.6% (142/144) [95.1-99.6] |
| | | 24/24 | 23/24 | 47/48 | 24/24 | 23/24 | 47/48 | 24/24 | 24/24 | 48/48 | |
| Panel 3 | V. parahaemolyticus Low Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (108/108) [96.6-100.0] |
| | | 18/18 | 18/18 | 36/36 | 18/18 | 18/18 | 36/36 | 18/18 | 18/18 | 36/36 | |
| Panel 3 | V. parahaemolyticus Mod Pos | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (108/108) [96.6-100.0] |
| | | 18/18 | 18/18 | 36/36 | 18/18b | 18/18 | 36/36 | 18/18 | 18/18 | 36/36 | |
| Panel 3 | Negative | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% (108/108) [96.6-100.0] |
| | | 18/18 | 18/18 | 36/36 | 18/18 | 18/18 | 36/36 | 18/18 | 18/18 | 36/36 | |

K251721 - Page 13 of 35

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a One sample was non-determinate on both initial and retest and was excluded from the analyses.
b One moderate positive sample tested positive for $V.$ parahaemolyticus and $V.$ cholerae. This sample was considered concordant for $V.$ parahaemolyticus.

The evaluation of reproducibility and within-laboratory precision of the underlying analyte response (Ct, melt peak (MP), or melt valley (MV) values) for the Xpert GI Panel was analyzed using nested Analysis of Variance (ANOVA). The mean response (Ct, MP or MV), standard deviation (SD), and coefficient of variation (CV) between-sites, between-operators, between-lots, between-days, between-runs and within-run for each panel member are presented in Table 2.

Table 2: Summary of Nested ANOVA by Coefficient of Variation

| Sample | Response | N | Mean Ct, MP, or MV | Variance Source | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | Site | | Operator | | Lot | | Day | | Run | | Within-Run | | Total |
| | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD |
| Campylobacter Low Pos | MP | 144 | 15.6 | 0.6 | 3.6 | 0.0 | 0.0 | 1.2 | 7.6 | 0.7 | 4.4 | 0.0 | 0.0 | 1.9 | 12.2 | 2.4 |
| | MV | 144 | -13 | 0.4 | 3.3 | 0.0 | 0.0 | 0.9 | 7.2 | 0.6 | 4.3 | 0.0 | 0.0 | 1.5 | 11.6 | 1.9 |
| Campylobacter Mod Pos | MP | 144 | 16.4 | 0.6 | 3.5 | 0.0 | 0.0 | 0.6 | 3.8 | 0.6 | 3.7 | 0.0 | 0.0 | 1.6 | 9.9 | 1.9 |
| | MV | 144 | -13.7 | 0.6 | 4.3 | 0.0 | 0.0 | 0.5 | 3.8 | 0.5 | 3.5 | 0.0 | 0.0 | 1.3 | 9.5 | 1.6 |
| STEC stx2 Low Pos | MP | 144 | 12.9 | 0.9 | 6.6 | 0.0 | 0.0 | 0.7 | 5.7 | 0.0 | 0.0 | 0.1 | 0.9 | 1.7 | 13.0 | 2.0 |
| | MV | 144 | -12.1 | 0.7 | 6.0 | 0.0 | 0.0 | 0.7 | 5.7 | 0.3 | 2.2 | 0.0 | 0.0 | 1.7 | 13.9 | 2.0 |
| STEC stx2 Mod Pos | MP | 144 | 14.1 | 1.1 | 8.0 | 0.0 | 0.0 | 0.5 | 3.2 | 0.8 | 5.7 | 0.4 | 3.2 | 1.8 | 12.7 | 2.3 |
| | MV | 144 | -13.4 | 1.0 | 7.4 | 0.0 | 0.0 | 0.4 | 2.9 | 0.7 | 5.3 | 0.5 | 3.9 | 1.8 | 13.5 | 2.3 |
| Salmonella Low Pos | Ct | 144 | 34.6 | 0.4 | 1.0 | 0.2 | 0.4 | 0.0 | 0.0 | 0.3 | 0.8 | 0.0 | 0.0 | 0.7 | 1.9 | 0.8 |
| Salmonella Mod Pos | Ct | \( 143^a \) | 33.7 | 0.2 | 0.7 | 0.2 | 0.5 | 0.3 | 0.8 | 0.0 | 0.0 | 0.2 | 0.7 | 0.6 | 1.8 | 0.8 |
| Yersinia Low Pos | MP | \( 143^b \) | 14.2 | 0.4 | 2.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.7 | 5.0 | 1.4 | 10.0 | 1.6 |
| | MV | 143 | -11.7 | 0.4 | 3.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.6 | 4.8 | 1.2 | 9.9 | 1.4 |
| Yersinia Mod Pos | MP | \( 143^c \) | 14.7 | 0.6 | 3.7 | 0.0 | 0.0 | 0.5 | 3.2 | 0.0 | 0.0 | 0.0 | 0.0 | 1.8 | 12.0 | 1.9 |
| | MV | \( 143^d \) | -12.3 | 0.5 | 4.0 | 0.0 | 0.0 | 0.4 | 3.0 | 0.0 | 0.0 | 0.2 | 1.4 | 1.4 | 11.1 | 1.5 |
| Cryptosporidium Low Pos | Ct | 144 | 23.3 | 0.6 | 2.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.5 | 2.1 | 0.0 | 0.0 | 1.6 | 6.8 | 1.8 |
| Cryptosporidium Mod Pos | Ct | \( 143^e \) | 22.3 | 0.5 | 2.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.4 | 1.6 | 0.5 | 2.2 | 1.0 | 4.4 | 1.2 |
| Giardia Low Pos | Ct | 144 | 27.4 | 1.3 | 4.6 | 0.0 | 0.0 | 1.2 | 4.4 | 0.7 | 2.4 | 1.2 | 4.3 | 1.6 | 5.7 | 2.7 |
| Giardia Mod Pos | Ct | 144 | 26.6 | 1.2 | 4.5 | 0.0 | 0.0 | 1.4 | 5.4 | 0.4 | 1.6 | 1.1 | 4.2 | 1.3 | 4.9 | 2.6 |
| Shigella EIEC Low Pos | Ct | 144 | 32.8 | 0.4 | 1.1 | 0.1 | 0.3 | 0.2 | 0.5 | 0.1 | 0.4 | 0.0 | 0.0 | 0.8 | 2.3 | 0.9 |
| Shigella EIEC Mod Pos | Ct | 144 | 31.9 | 0.1 | 0.4 | 0.2 | 0.6 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | 0.7 | 2.3 | 0.8 |
| Norovirus Low Pos | Ct | 144 | 33.2 | 0.3 | 0.9 | 0.0 | 0.0 | 0.2 | 0.6 | 0.3 | 0.8 | 0.3 | 0.8 | 0.6 | 2.0 | 0.8 |
| Norovirus Mod Pos | Ct | 144 | 32 | 0.3 | 0.9 | 0.0 | 0.1 | 0.1 | 0.4 | 0.1 | 0.4 | 0.1 | 0.3 | 0.6 | 1.8 | 0.7 |
| V. | MP | 108 | 15.5 | 1.3 | 8.4 | 0 | 0 | 0.9c | 5.8c | NAc | NAc | 0.8 | 5.1 | 2 | 12.9 | 2.7 |

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| Sample | Response | N | Mean Ct, MP, or MV | Variance Source | | | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | Site | | Operator | | Lot | | Day | | Run | | Within-Run | | Total |
| | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD |
| parahaemolyticusLow Pos | MV | 108 | -13.5 | 1.1 | 8.1 | 0 | 0 | 0.8^{a} | 5.7^{a} | NA^{a} | NA^{a} | 0.8 | 6.2 | 1.8 | 13.5 | 2.4 |
| V. parahaemolyticusMod Pos | MP | 108 | 16.2 | 1.1 | 6.7 | 0 | 0 | 0.8^{b} | 5.1^{b} | NA^{b} | NA^{b} | 0.2 | 1.5 | 2.2 | 13.4 | 2.6 |
| | MV | 108 | -14.1 | 0.9 | 6.2 | 0 | 0 | 0.8^{b} | 5.6^{b} | NA^{b} | NA^{b} | 0.1 | 0.8 | 2 | 14.1 | 2.3 |

aOne (1) sample excluded due to a non-determinate result
bOne (1) sample excluded due to negative Yersinia result with missing melt peak and melt valley values
The variation of lot and day are confounded and cannot be separated.

2. Linearity:

Not applicable as this is a qualitative assay.

3. Analytical Specificity/Interference:

a. Analytical Reactivity:

The analytical reactivity (inclusivity) of the Xpert GI Panel test was evaluated by utilizing multiple clinically relevant strains for each Xpert GI Panel target pathogen, representative of genotypic differences from various geographical regions. All strains were tested at ≤3x LoD with a minimum of five replicates using the Xpert GI Panel test, except for one strain which was assessed using in silico analysis against the Xpert GI Panel primer and probe sequences. If a target pathogen strain reported negative results for one replicate or more at ≤3x LoD, the strain was subsequently tested at a higher concentration. A strain was considered detected when all replicates at a test level were reported positive. Table 3 to Table 13 present the evaluated strains, test levels and the results for detection.

Table 3: Inclusivity Results for Campylobacter

| Species/Subtype | Strain ID | Test Level (x LoD) | Test Concentration (CFU/mL) | Reported Results |
| --- | --- | --- | --- | --- |
| Campylobacter coli | CCUG 10960 | 3x LoD | 549 | Positive |
| | CCUG 53138 | 3x LoD | 549 | Positive |
| | ATCC 43478 | 3x LoD | 549 | Positive |
| | CCUG 36766 | 3x LoD | 549 | Positive |
| | CCUG 59141 | 3x LoD | 549 | Positive |
| Campylobacter jejuni | CCUG 10259 | 3x LoD | 549 | Positive |
| | Zeptometrix 0801650 | 3x LoD | 549 | Positive |
| Campylobacter jejunisubsp. doylei | CCUG 24567T | 3x LoD | 549 | Positive |
| | CCUG 11284T | 3x LoD | 549 | Positive |
| | CCUG 14541 | 3x LoD | 549 | Positive |
| Campylobacter jejuni subsp. jejuni | CCUG 33057 | 3x LoD | 549 | Positive |
| | CCUG 6824 | 3x LoD | 549 | Positive |
| | ATCC 33560 | 3x LoD | 549 | Positive |
| Campylobacter fetus | CCUG 71557 | 3.9x LoD | 720 | Negative |
| | | 8.2x LoD | 1,500 | Negative |

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| Species/Subtype | Strain ID | Test Level (x LoD) | Test Concentration (CFU/mL) | Reported Results |
| --- | --- | --- | --- | --- |
| | | 131x LoD | 24,000 | Negative |
| Campylobacter lari | CCUG 15031 | 3.9x LoD | 720 | Negative |
| | | 131x LoD | 24,000 | Negative |
| Campylobacter upsaliensis | CCUG 14913T | 3.9x LoD | 720 | Negative |
| | | 8.2x LoD | 1,500 | Negative |
| | | 131x LoD | 24,000 | Negative |
| | CCUG 24191 | 3.9x LoD | 720 | Negative |
| | | 8.2x LoD | 1,500 | Negative |
| | | 131x LoD | 24,000 | Negative |

Table 4: Inclusivity Results for Cryptosporidium

| Target Pathogen Strain | Strain ID | Test Concentration (oocysts/mL or cp/mL for Synthetic DNA) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Cryptosporidium parvum | IDT Synthetic DNA, L25642 | 3,690 | 3x LoD | Positive |
| Cryptosporidium | IDT Synthetic DNA, EF179381 | 3,690 | 3x LoD | Positive |
| Cryptosporidium canis | IDT Synthetic DNA, AF112576 | 3,690 | 3x LoD | Positive |
| Cryptosporidium ubiquitum | IDT Synthetic DNA, | 3,690 | 3x LoD | Positive |
| Cryptosporidium hominis | IDT Synthetic DNA, | 3,690 | 3x LoD | Positive |
| Cryptosporidium muris | Waterborne Inc. P104, RN66 | 480,000 | 390x LoD | Negative (a) |
| | IDT Synthetic DNA, AB089284 | 100,000 | 81xLoD | Positive (b) |

(a) Two out of five replicates and one out of five replicates were detected at 134xLoD and 390x LoD respectively.
(b) Three out of five replicates, eight out of ten replicates and nine out of ten replicates were detected at 8.1x LoD, 33x LoD and 57x LoD respectively.

Table 5: Inclusivity Results for STEC

| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| STEC stx1 (O103) | NCTC 13782 | 1,872 | 3x LoD | Positive |
| STEC stx1 (O45) | Microbiologics 01098P (CDC 00-) | 1,872 | 3x LoD | Positive |
| STEC stx2 (O121) | Statens Serum Institute D6088 | 9,030 | 3x LoD | Positive |
| STEC stx2 (O145) | NCTC 13797 | 9,030 | 3x LoD | Positive |
| STEC stx2 (O113) | Statens Serum Institute D5586 | 9,030 | 3x LoD | Positive |
| STEC stx2 (O104) | NCTC 13796 | 9,030 | 3x LoD | Positive |
| STEC stx1/stx2 (O26) | NCTC 13733 | 1,872 | 3x LoD (stx1) | Positive |
| | | | 0.6x LoD (stx2) | Positive |
| STEC stx1/stx2 (O111) | NCTC 13794 | 1,872 | 3x LoD (stx1) | Positive |
| | | | 0.6x LoD (stx2) | Positive |
| STEC stx1/stx2 (O157) | Microbiologics 0617P (ATCC 35150) | 1,872 | 3x LoD (stx1) | Positive |
| | | | 0.6x LoD (stx2) | Positive |

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Table 6: Inclusivity Results for Norovirus

| Target Pathogen Strain | Strain ID | Test Concentration (cp/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Norovirus GII.4 | Clinical Specimen, DLS0113053, CerbaXpert | 60 | 0.2x LoD | Positive (a) |
| Norovirus | Clinical Specimen, 460878, Precision for | 298 | 1x LoD | Positive |
| Norovirus GI.6 | Clinical Specimen 13CA514199, Karolinska Hospital Sweden | 298 | 1x LoD | Positive |
| | | 3 | 0.01x LoD | |
| Norovirus GII.3[P12] | Clinical Specimen 435625, Precision for Medicine U.S. | 894 | 3x LoD | Positive |
| | | 9 | 0.03x LoD | |
| Norovirus | Clinical Specimen 487208, Precision for Medicine | 894 | 3x LoD | Positive |
| Norovirus | Clinical Specimen 461526, Precision for Medicine | 894 | 3x LoD | Positive |
| Norovirus | Clinical Specimen 487198, Precision for Medicine | 894 | 3x LoD | Positive |
| Norovirus GI | Clinical Specimen GI 1, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GI E, Karolinska Hospital | Unknown (b) | NA | Positive |
| Norovirus GII | Clinical Specimen GII 1, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GII 2, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GII 3, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen, GII 4 Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GII 5, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GII A, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GII B, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GII C, Karolinska Hospital | Unknown (b) | NA | Positive |
| | Clinical Specimen GII D, Karolinska Hospital | Unknown (b) | NA | Positive |
| Norovirus GI.1 | IDT Synthetic RNA, NC-001959 | 12,600 | 4x LoD | Positive |
| Norovirus GI.2 | IDT Synthetic RNA, NMZ223426 | 25,200 | 8x LoD | Positive |
| Norovirus GI.4 | IDT Synthetic RNA, MH393671 | 12,600 | 4x LoD | Positive |
| Norovirus GI.5 | IDT Synthetic RNA, MT908122 | 9,390 | 3x LoD | Positive |
| Norovirus GI.7 | IDT Synthetic RNA, MT357994 | 25,200 | 8x LoD | Positive |
| Norovirus GII.2 | IDT Synthetic RNA, KJ407074, | 9,390 | 3x LoD | Positive |
| Norovirus GII.4 | IDT Synthetic RNA, X86557 | 9,390 | 3x LoD | Positive |
| Norovirus GII.10 | IDT Synthetic RNA, MT501863 | 9,390 | 3x LoD | Positive |
| Norovirus GII.12 | IDT Synthetic RNA, HQ449728 | 18,800 | 6x LoD | Positive |
| Norovirus GII.15 | IDT Synthetic RNA, OK247589 | 18,800 | 6x LoD | Positive |
| Norovirus GII.17 | IDT Synthetic RNA, KT190704 | 9,390 | 3x LoD | Positive |

(a) The strain is considered detected since 19 from 20 replicates were reported positive at $< 1$ LoD.
(b) Clinical specimens with unknown titers and one replicate tested per specimen.

Table 7: Inclusivity Results for Salmonella

| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Salmonella bongori | CCUG 63587 | 2,400 | 1.9x LoD | Positive |
| Salmonella enterica subsp. salamae | CCUG 30039T | 2,400 | 1.9x LoD | Positive |
| Salmonella enterica subsp. arizonae | CCUG 6322T | 2,400 | 1.9x LoD | Positive |
| | CCUG 63588 | 2,400 | 1.9x LoD | Positive |
| | CCUG 63589 | 2,400 | 1.9x LoD | Positive |

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K251721 - Page 18 of 35
| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| *Salmonella enterica* subsp. *diarizonae* | CCUG 30040T | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *houtenae* | CCUG 30041T | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *indica* | CCUG 30038T | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Agona | CCUG 21287 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Anatum | CCUG 21243 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Bareilly | CCUG 12616 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Berta | CCUG 27106 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Blockley | CCUG 21263 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Branderup | CCUG 50923 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Derby | CCUG 21276 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Enteritidis | CCUG 34136T | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Hadar | CCUG 21271 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Heidelberg | CCUG 21289 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* serotype Typhimurium 4,5,12: i: 1,2 | CCUG 18375 | 2,400 | 1.9x LoD | Positive |
| | ATCC 14028 | 2,400 | 1.9x LoD | Positive |
| | CCUG 42060T | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Infantis | CCUG 12615 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Javiana | CCUG 21235 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Litchfield | NCTC 6028 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Mbandaka | CCUG 21272 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Mississippi | Clinical Specimen S027019, Public Health Agency of Sweden | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Montevideo | CCUG 21239 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Muenchen | CCUG 21254 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Newport | CCUG 21283 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Oranienburg | CCUG 12649 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Panama | CCUG 21275 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Paratyphi A | NCTC 5702 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Poona | CCUG 39842 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Reading | NCTC 5720 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Saintpaul | CCUG 21282 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Sandiego | NCTC 6024 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* | CCUG 21280 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Senftenberg | CCUG 37886 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Stanley | CCUG 26623 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Thompson | CCUG 12652 | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Typhi | Clinical Specimen 22-00912, Public Health Agency of Sweden | 2,400 | 1.9x LoD | Positive |
| *Salmonella enterica* subsp. *enterica* Typhimurium | CCUG 35118 | 2,400 | 1.9x LoD | Positive |

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Table 8: Inclusivity Results for Shigella

| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Shigella boydii (Subgroup C, serotype 8) | CCUG 37892 | 612 | 3x LoD | Positive |
| Shigella boydii (Subgroup C, serotype 10) | CCUG 9564 | 612 | 3x LoD | Positive |
| Shigella boydii (Subgroup C, serotype 11) | ATCC 12031 | 612 | 3x LoD | Positive |
| Shigella dysenteriae (Subgroup A, serotype 1) | NCTC 4837 (a) | 204 | 1x LoD | Positive |
| | NCTC 8217 (a) | 612 | 3x LoD | Positive |
| | NCTC 8571 (a) | 612 | 3x LoD | Positive |
| Shigella dysenteriae (Subgroup A, | NCTC 9345 | 612 | 3x LoD | Positive |
| Shigella dysenteriae (Subgroup A, | NCTC 9348 | 612 | 3x LoD | Positive |
| Shigella flexneri (Subgroup B, serotype | CCUG 56439T | 1,224 | 6x LoD | Positive |
| Shigella flexneri (Subgroup B, serotype 3) | CCUG 21251 | 612 | 3x LoD | Positive |
| Shigella flexneri (Subgroup B, serotype | CCUG 37906 | 612 | 3x LoD | Positive |
| Shigella flexneri (Subgroup B, serotype 6) | CCUG 39080 | 612 | 3x LoD | Positive |
| | ATCC 15391 | 612 | 3x LoD | Positive |
| Shigella sonnei (Subgroup D) | CCUG 9567 | 612 | 3x LoD | Positive |
| Shigella dysenteriae (Subgroup A, serotype 9) | ATCC 49547 | In silico analysis | NA | 100% match with primer and probe |

(a) Shigella strains carrying STEC stx1 gene.

Table 9: Inclusivity Results for EIEC

| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Enteroinvasive Escherichia coli (EIEC) | CCUG 38092 | 204 | 1x LoD | Positive |
| | CCUG 38094 | 612 | 3x LoD | Positive |
| | NCTC 9013 | 70,000 | 343x LoD | Negative (a) |

(a) Secondary PCR assay could confirm the absence of EIEC target gene ipaH in strain NCTC 9013, i.e., target gene loss confirmed.

Table 10: Inclusivity Results for Vibrio cholerae

| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Vibrio cholerae O:139 | CCUG 34707 | 1,200 | 2.6x LoD | Positive |
| Vibrio cholerae O:1 | CCUG 9118T | 1,200 | 2.6x LoD | Positive |

Table 11: Inclusivity Results for V. parahaemolyticus

| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Vibrio parahaemolyticus | CCUG 19113 | 1,467 | 3x LoD | Positive |
| | CCUG 15657T | 1,467 | 3x LoD | Positive |
| | CCUG 43362 | 1,467 | 3x LoD | Positive |

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Table 12: Inclusivity Results for Yersinia

| Target Pathogen Strain | Strain ID | Test Concentration (CFU/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Yersinia enterocolitica biotype 1 (O:8) | CCUG 33055 | 1,044 | 3x LoD | Positive |
| Yersinia enterocolitica biotype 2 (O:9) | CCUG 8239A | 1,044 | 3x LoD | Positive |
| Yersinia enterocolitica biotype 2 (O:5, 2) | NCTC 10463 | 1,044 | 3x LoD | Positive |
| Yersinia enterocolitica biotype 4 (O:3) | CCUG 34604 | 1,044 | 3x LoD | Positive |

Table 13: Inclusivity Results for Giardia

| Target Pathogen Strain | Strain ID | Test Concentration (cysts/mL) | Multiple of LoD | Reported Results |
| --- | --- | --- | --- | --- |
| Giardia intestinalis | ATCC 30888 | 1 | 3x LoD | Positive |
| | ATCC 50114 | 1 | 3x LoD | Positive |

b. Analytical Specificity (Exclusivity) and Microbial Interference:

The analytical specificity (exclusivity), microbial interference and in-assay cross reactivity of the Xpert GI Panel test were evaluated using microorganisms commonly found in stool and rectal flora. A total of 136 microorganisms were either tested with the Xpert GI Panel test (131 microorganisms) or assessed using in silico analysis directed against the Xpert GI Panel probe and primer sequences (five microorganisms). The non-target microorganisms evaluated using the Xpert GI Panel test were diluted into clinical stool matrix at high concentrations and tested in absence of target pathogens using three replicates, and in presence of target pathogens diluted to ≤ 3x LoD using six replicates. Non-target bacteria were tested at 1E6 CFU/mL and non-target viruses and parasites/yeast were tested at ≥ 1E4 units/mL. The in-assay cross reactivity was evaluated using a subset of target pathogen strains, individually tested at high concentrations using six replicates, to determine potential cross-reactivity with the primers and probes included in the Xpert GI Panel test. Target pathogen strains evaluated for in-assay cross reactivity were tested at 1E6 units/mL, except for Cryptosporidium parvum which was tested at 9.94E4 oocysts/mL.

No cross-reactivity or microbial interference was observed for any of the tested non-target microorganisms using the Xpert GI Panel test. The risk for cross reactivity or interference with the Xpert GI Panel test for other select pathogens was determined to be low using in silico analysis for five of the non-target microorganisms. No in-assay cross reactivity was observed for any of the Xpert GI Panel target pathogens tested at high concentrations. Table 14, Table 15, and Table 16 present the bacteria, viruses, parasites/yeast evaluated in the Xpert GI Panel analytical (exclusivity) and microbial interference study respectively. Table 17 presents the target pathogen strains evaluated for in-assay cross reactivity of the Xpert GI Panel test.

Table 14: Non-Target Bacteria included in Analytical Specificity and Microbial Interference Studies

| Non-target Microorganism | Strain ID | Concentration Tested |
| --- | --- | --- |
| Abiotrophia defectiva | CCUG 27639 | 1E6 CFU/mL |
| Acinetobacter baumannii | CCUG 19096T | 1E6 CFU/mL |

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K251721 - Page 21 of 35
| Non-target Microorganism | Strain ID | Concentration Tested |
| --- | --- | --- |
| Acinetobacter lwoffii | ZeptoMetrix 0801909 | 1E6 CFU/mL |
| Aeromonas caviae | CCUG 25939 | 1E6 CFU/mL |
| Aeromonas salmonicida (Aeromonas | ATCC 7965 | 1E6 CFU/mL |
| Aeromonas schubertii | CCUG 27820 | 1E6 CFU/mL |
| Aeromonas sobria | CCUG 14830 | 1E6 CFU/mL |
| Aeromonas veronii | CCUG 27821T | 1E6 CFU/mL |
| Alcaligenes faecalis subsp. faecalis | CCUG 1814T | 1E6 CFU/mL |
| Anaerococcus tetradius | CCUG 46590T | 1E6 CFU/mL |
| Arcobacter butzleri | CCUG 30485 | 1E6 CFU/mL |
| Arcobacter cryaerophilus | CCUG 17801 | 1E6 CFU/mL |
| Bacillus cereus | ZeptoMetrix 0801823 | 1E6 CFU/mL |
| Bacteroides caccae | ATCC 43185 | 1E6 CFU/mL |
| Bacteroides fragilis | ZeptoMetrix 0801583 | 1E6 CFU/mL |
| Bacteroides stercoris | ATCC 43183 | 1E6 CFU/mL |
| Bacteroides thetaiotaomicron | CCUG 10774 | 1E6 CFU/mL |
| Phocaeicola vulgatus (Bacteroides vulgatus) | ATCC 8482 | 1E6 CFU/mL |
| Bifidobacterium adolescentis | CCUG 18363T | 1E6 CFU/mL |
| Bifidobacterium bifidum | CCUG 45217 | 1E6 CFU/mL |
| Bifidobacterium longum subsp. longum | ATCC 15707 | 1E6 CFU/mL |
| Brevundimonas diminuta | CCUG 2031 | 1E6 CFU/mL |
| Cedecea davisae | CCUG 12370 | 1E6 CFU/mL |
| Chlamydia trachomatis | ZeptoMetrix 0801775 | 1E6 CFU/mL |
| Citrobacter amalonaticus | CCUG 4860A | 1E6 CFU/mL |
| Citrobacter freundii | ZeptoMetrix 0801563 | 1E6 CFU/mL |
| Citrobacter koseri | CCUG 4859 | 1E6 CFU/mL |
| Citrobacter sedlakii | CCUG 30794 | 1E6 CFU/mL |
| Clostridium difficile | ZeptoMetrix 0801619 | 1E6 CFU/mL |
| Hathewaya histolytica (Clostridium histolyticum) | ATCC 19401 | 1E6 CFU/mL |
| Clostridium novyi | ATCC 17861 | 1E6 CFU/mL |
| Clostridium perfringens | ATCC 13124 | 1E6 CFU/mL |
| Thoamsclavelia ramosa (Clostridium ramosum) | CCUG 24038 | 1E6 CFU/mL |
| Clostridium septicum | ATCC 12464 | 1E6 CFU/mL |
| Paeniclostridium sordellii (Clostridium sordellii) | DSMZ 2141 | 1E6 CFU/mL |
| Clostridium tetani | ATCC 19406 | 1E6 CFU/mL |
| Collinsella aerofaciens | CCUG 28087 | 1E6 CFU/mL |
| Corynebacterium genitalium | CCUG 65575 | 1E6 CFU/mL |
| Corynebacterium lipophiloflavum | CCUG 37336 | 1E6 CFU/mL |
| Desulfovibrio piger | NA | In silico analysis |
| Edwardsiella tarda | CCUG 1638 | 1E6 CFU/mL |
| Eggerthella lenta | ATCC 43055 | 1E6 CFU/mL |
| Klebsiella aerogenes (Enterobacter aerogenes) | ZeptoMetrix 0801518 | 1E6 CFU/mL |
| Enterobacter cancerogenus | ATCC 35316 | 1E6 CFU/mL |
| Enterobacter cloacae subsp. cloacae | ZeptoMetrix 0801830 | 1E6 CFU/mL |
| Enterococcus faecalis | ZeptoMetrix 0801637 | 1E6 CFU/mL |

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K251721 - Page 22 of 35
| Non-target Microorganism | Strain ID | Concentration Tested |
| --- | --- | --- |
| Enterococcus faecium | ZeptoMetrix 0804210 | 1E6 CFU/mL |
| Enteroaggregative E. coli EAEC | ZeptoMetrix 0801919 | 1E6 CFU/mL |
| Enteropathogenic E. coli EPEC | ZeptoMetrix 0801938 | 1E6 CFU/mL |
| Enterotoxigenic E. coli ETEC | ZeptoMetrix 0801624 | 1E6 CFU/mL |
| Escherichia fergusonii | CCUG 18766 | 1E6 CFU/mL |
| Escherichia hermannii | CCUG 15714 | 1E6 CFU/mL |
| Pseud Escherichia vulneris (Escherichia vulneris) | CCUG 15715 | 1E6 CFU/mL |
| Fusobacterium varium | ATCC 8501 | 1E6 CFU/mL |
| Gardnerella vaginalis | ZeptoMetrix 0801894 | 1E6 CFU/mL |
| Gemella morbillorum | CCUG 18164 | 1E6 CFU/mL |
| Hafnia alvei | CCUG 41547T | 1E6 CFU/mL |
| Helicobacter fennelliae | CCUG18820 | 1E6 CFU/mL |
| Helicobacter pylori | ZeptoMetrix 0804383 | 1E6 CFU/mL |
| Haemophilus influenzae | ZeptoMetrix 0801679 | 1E6 CFU/mL |
| Klebsiella oxytoca | ZeptoMetrix 0801881 | 1E6 CFU/mL |
| Klebsiella pneumoniae subsp. pneumoniae | CCUG 225T | 1E6 CFU/mL |
| Lactobacillus acidophilus | ATCC 314 | 1E6 CFU/mL |
| Limosilactobacillus reuteri | CCUG 33624 | 1E6 CFU/mL |
| Lactococcus lactis subsp. lactis | CCUG 32211 | 1E6 CFU/mL |
| Leminorella grimontii | CCUG 20909B | 1E6 CFU/mL |
| Listeria monocytogenes | ZeptoMetrix 0801534 | 1E6 CFU/mL |
| Megamonas hypermegale | CCUG 5856 | 1E6 CFU/mL |
| Megasphaera elsdenii | ATCC 25940 | 1E6 CFU/mL |
| Morganella morganii subsp. morganii | ZeptoMetrix 0804010 | 1E6 CFU/mL |
| Neisseria gonorrhoeae | ZeptoMetrix 0801482 | 1E6 CFU/mL |
| Parabacteroides merdae | CCUG 38734 | 1E6 CFU/mL |
| Peptoniphilus asaccharolyticus | ATCC 14963 | 1E6 CFU/mL |
| Peptostreptococcus anaerobius | CCUG 7835 | 1E6 CFU/mL |
| Photobacterium damselae subsp. damselae | CCUG 13626 | 1E6 CFU/mL |
| Pleisomonas shigelloides | CCUG 410T | 1E6 CFU/mL |
| Porphyromonas asaccharolytica | CCUG 7834T | 1E6 CFU/mL |
| Prevotella melaninogenica | ATCC 25845 | 1E6 CFU/mL |
| Proteus mirabilis | ZeptoMetrix 0801544 | 1E6 CFU/mL |
| Proteus penneri | CCUG 15722 | 1E6 CFU/mL |
| Proteus vulgaris | ZeptoMetrix 0801898 | 1E6 CFU/mL |
| Providencia alcalifaciens | ZeptoMetrix 0801906 | 1E6 CFU/mL |
| Pseudomonas aeruginosa | CCUG 551T | 1E6 CFU/mL |
| Ruminococcus bromii | ATCC 27255 | 1E6 CFU/mL |
| Serratia fonticola | CCUG 14186 | 1E6 CFU/mL |
| Serratia liquefaciens | CCUG 9285T | 1E6 CFU/mL |
| Serratia marcescens subsp. marcescens | ZeptoMetrix 0801723 | 1E6 CFU/mL |
| Shewanella algae | CCUG 39064 | 1E6 CFU/mL |
| Shimwellia blattae | CCUG 14803BT | 1E6 CFU/mL |
| Staphylococcus aureus subsp. aureus | ATCC 25923 | 1E6 CFU/mL |
| Staphylococcus epidermidis | ZeptoMetrix 0801651 | 1E6 CFU/mL |

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Table 15: Non-Target Viruses included in Analytical Specificity and Microbial Interference Studies

| Non-target Microorganism | Strain ID | Concentration Tested |
| --- | --- | --- |
| Adenovirus Type 1 | ZeptoMetrix 0810050CF | 1E6 TCID50/mL |
| Adenovirus Type 3 | ZeptoMetrix 0810062CF | 5E5 TCID50/mL(a)1E4 TCID50/mL(b) |
| Adenovirus Type 4 | ZeptoMetrix 0810070CF | 5E4 TCID50/mL(a) |
| Adenovirus Type 5 | ZeptoMetrix 0810020CF | 1E6 TCID50/mL |
| Adenovirus Type 8 | ZeptoMetrix 0810069CF | 2E4 TCID50/mL(a)1E4 TCID50/mL(b) |
| Adenovirus Type 14 | ZeptoMetrix 0810108CF | 1E5 TCID50/mL |
| Adenovirus Type 18 | NA | In silico analysis |
| Adenovirus Type 31 | ZeptoMetrix 0810073CF | 1E5 TCID50/mL |
| Adenovirus Type 40 | ZeptoMetrix 0810084CF | 1E5 TCID50/mL |
| Adenovirus Type 41 | ZeptoMetrix 0810085CF | 1E5 TCID50/mL |
| Astrovirus | ATCC VR-1936 | 1E6 TCID50/mL |
| Parvovirus | ZeptoMetrix 0810064C | 1E6 IU/mL |
| Cytomegalovirus | ATCC VR-538 | 5E5 TCID50/mL |
| Enterovirus | ATCC VR-836 | 5E5 TCID50/mL |
| Hepatitis A virus | ATCC VR-1541 | 5E5 TCID50/mL |
| Herpes Simplex Virus Type 2 | ZeptoMetrix 0810006CF | 5E5 TCID50/mL |
| Human coxsackievirus | ZeptoMetrix 0810074CF | 5E5 TCID50/mL |
| Rhinovirus | ZeptoMetrix 0810012CFN | 2E4 TCID50/mL(a)1E5 TCID50/mL(b) |
| Rotavirus | ATCC VR-2551 | 1E6 TCID50/mL |
| Sapovirus | ATCC VR-3237SD | 1E7 genome copies/mL(a)1E6 genome copies/mL(b) |

(a) Concentration of the non-target microorganism tested with Salmonella enterica, Giardia lamblia, Vibrio cholerae and negative sample.
(b) Concentration of the non-target microorganism tested with Campylobacter jejuni, STEC stx1 and stx2, EIEC, Yersinia enterocolitica, Vibrio parahaemolyticus, Cryptosporidium parvum and Norovirus GI and GII.

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Table 16: Non-Target Parasites/Yeast included in Analytical Specificity and Microbial Interference Studies

| Non-target Microorganism | Strain ID | Concentration Tested |
| --- | --- | --- |
| Blastocystis hominis | NA | In silico analysis |
| Candida albicans | ZeptoMetrix 0801504 | 1E6 CFU/mL |
| Cyclospora cayetanensis | ATCC PRA-3000SD | 1E7 copies/mL(a)
1E6 copies/mL(b) |
| Encephalitozoon cuniculi | NA | In silico analysis |
| Encephalitozoon hellum | NA | In silico analysis |
| Entamoeba dispar | ATCC PRA-368 | N/A(c) |
| Entamoeba histolytica | ATCC 30459 | 2E4 cells/mL(a)
1E4 cells/mL(b) |
| Entamoeba invadens | ATCC 30994 | 5E4 cells/mL |
| Pentatrichomonas hominis | ATCC 30000 | 1E6 cells/mL |
| Trichomonas vaginalis | ZeptoMetrix 0801805 | 1E5 trophozoites/mL |
| Entamoeba histolytica | ATCC 30459 | 2E4 cells/mL(a)
1E4 cells/mL(b) |

(a) Concentration of the non-target microorganism tested with Salmonella enterica, Giardia lamblia, Vibrio cholerae and negative sample.
(b) Concentration of the non-target microorganism tested with Campylobacter jejuni, STEC stx1 and stx2, EIEC, Yersinia enterocolitica, Vibrio parahaemolyticus, Cryptosporidium parvum and Norovirus GI and GII.
(c) For Entamoeba dispar, ATCC PRA-368, no titer or cell count was available according to vendor ATCC. According to the Certificate of Analysis, the microorganism was released based on visual observation methods.

Table 17: Target Pathogen Strains evaluated in Cross-Reactivity Study

| Target Pathogen | Strain ID | Concentration Tested |
| --- | --- | --- |
| Campylobacter coli | CCUG 53138 | 1E6 CFU/mL |
| | ATCC 43478 | 1E6 CFU/mL |
| | CCUG 36766 | 1E6 CFU/mL |
| Shigella boydii (Subgroup C, serotype 8) | CCUG 37892 | 1E6 CFU/mL |
| Shigella boydii (Subgroup C, serotype 10) | CCUG 9564 | 1E6 CFU/mL |
| Shigella flexneri (Subgroup B, serotype 2a) | CCUG 56439T | 1E6 CFU/mL |
| Shigella flexneri (Subgroup B, serotype 4a) | CCUG 37906 | 1E6 CFU/mL |
| Enteroinvasive Escherichia coli (EIEC) | CCUG 38094 | 1E6 CFU/mL |
| Escherichia coli (STEC), O111 | NCTC 13794 | 1E6 CFU/mL |
| Escherichia coli (STEC), O113 | D5586 | 1E6 CFU/mL |
| Escherichia coli (STEC), O104 | NCTC 13796 | 1E6 CFU/mL |
| Salmonella bongori | CCUG 63587 | 1E6 CFU/mL |
| Salmonella enterica subsp. indica | CCUG 30038T | 1E6 CFU/mL |
| Salmonella enterica subsp. enterica | NCTC 5702 | 1E6 CFU/mL |
| Vibrio cholerae, O:139 (non-O:1) | CCUG 34707 | 1E6 CFU/mL |
| Vibrio cholerae, O:1 | CCUG 9118T | 1E6 CFU/mL |
| Vibrio parahaemolyticus | CCUG 43362 | 1E6 CFU/mL |
| | CCUG 19113 | 1E6 CFU/mL |
| | CCUG 15657T | 1E6 CFU/mL |
| Norovirus GI.3 [P3] | Clinical Specimen, 460878, Precision for Medicine U.S. | 1E6 cp/mL |
| Norovirus GII.7 | Clinical Specimen, 461526, Precision for Medicine U.S. | 1E6 cp/mL |

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| Target Pathogen | Strain ID | Concentration Tested |
| --- | --- | --- |
| Yersinia enterocolitica, subsp. enterocolitica, biotype 1 (serotype O:8) | CCUG 33055 | 1E6 CFU/mL |
| Yersinia enterocolitica, subsp. enterocolitica, biotype 2 (serotype O:5,27) | NCTC 10463 | 1E6 CFU/mL |
| Yersinia enterocolitica, subsp. enterocolitica, biotype 4 (serotype O:3) | CCUG 34604 | 1E6 CFU/mL |
| Cryptosporidium parvum | Waterborne Inc. P102C Iowa | 9.94E4 oocysts/mL |
| Cryptosporidium hominis | Waterborne Inc. TU502 | 1E6 oocysts/mL |
| Giardia intestinalis | ATCC 30888 | 1E6 cysts/mL |
| | ATCC 50114 | 1E6 cysts/mL |

c. Competitive Inhibition:

Competitive inhibition of the Xpert GI Panel test, caused by clinically relevant co-infections, was evaluated by testing 12 target pathogen combinations using a total of seven target pathogens, i.e., Campylobacter jejuni, Salmonella enterica, Giardia lamblia, Yersinia enterocolitica, STEC stx1, STEC stx2 and Norovirus GI. The target pathogens were tested at low concentrations, i.e., $\leq 3\mathrm{x}$ LoD in presence of one or more additional target pathogen(s) at a high concentration in negative clinical stool matrix. The high-test concentrations were 1E6 CFU/mL for bacterial pathogens, 1E5 cysts/mL for Giardia lamblia, and 1E5 cp/mL for Norovirus GI. All target pathogen combinations were diluted in clinical stool matrix and tested with six replicates. The study results showed no competitive inhibition for common gastrointestinal co-infections with the Xpert GI Panel test. Table 18 presents the target pathogen combinations and the reported results.

Table 18: Summary of Competitive Inhibition Study Results

| High Titer Target Pathogen | Low Titer Target Pathogen | Low Titer Testing Concentration (≤3x LoD) | Reported Result for Low Titer Target Pathogen |
| --- | --- | --- | --- |
| STEC stx1 (1E6 CFU/mL)
STEC stx2 (1E6 CFU/mL) | Campylobacter jejuni | 549 CFU/mL | Positive |
| | Salmonella enterica | 1,863 CFU/mL | Positive |
| Yersinia enterocolitica (1E6 CFU/mL) | Campylobacter jejuni | 549 CFU/mL | Positive |
| | Salmonella enterica | 1,863 CFU/mL | Positive |
| Norovirus GI (1E5 cp/mL) | Campylobacter jejuni | 549 CFU/mL | Positive |
| | Salmonella enterica | 1,863 CFU/mL | Positive |
| Campylobacter jejuni (1E6 CFU/mL)
Salmonella enterica (1E6 CFU/mL) | STEC stx1 | 1,872 CFU/mL | Positive |
| | STEC stx2 | 9,030 CFU/mL | Positive |
| Yersinia enterocolitica (1E6 CFU/mL) | STEC stx1 | 1,872 CFU/mL | Positive |
| | STEC stx2 | 9,030 CFU/mL | Positive |
| Norovirus GI (1E5 cp/mL) | STEC stx1 | 1,872 CFU/mL | Positive |
| | STEC stx2 | 9,030 CFU/mL | Positive |
| Campylobacter jejuni (1E6 CFU/mL)
Salmonella enterica (1E6 CFU/mL) | Yersinia enterocolitica | 1,044 CFU/mL | Positive |

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| High Titer Target Pathogen | Low Titer Target Pathogen | Low Titer Testing Concentration (≤3x LoD) | Reported Result for Low Titer Target Pathogen |
| --- | --- | --- | --- |
| STEC stx1 (1E6 CFU/mL)
STEC stx2 (1E6 CFU/mL) | Yersinia enterocolitica | 1,044 CFU/mL | Positive |
| Campylobacter jejuni (1E6 CFU/mL)
Salmonella enterica (1E6 CFU/mL) | Norovirus GI | 894 cp/mL | Positive |
| Giardia lamblia (1E5 cysts/mL)
Yersinia enterocolitica (1E6 CFU/mL) | Norovirus GI | 894 cp/mL | Positive |
| STEC stx1 (1E6 CFU/mL)
STEC stx2 (1E6 CFU/mL) | Norovirus GI | 894 cp/mL | Positive |
| Norovirus GI (1E5 cp/mL) | Giardia lamblia | 738 cysts/ml | Positive |
| | Yersinia enterocolitica | 1,044 CFU/mL | Positive |

## d. Potentially Interfering Substances Study:

A total of seven endogenous and twenty-nine exogenous substances, that may be encountered in clinical stool specimens, as well as four method-specific substances for collecting and storing clinical specimens, were evaluated for potential interference with the Xpert GI Panel test performance. Table 19 presents the evaluated substances and the corresponding test concentration in raw stool. Each potentially interfering substance was tested individually in clinical negative stool matrix in the absence and presence of representative Xpert GI Panel target pathogens respectively at a concentration of $3\mathrm{x}$ LoD using six replicates. The representative target pathogens included EIEC, Yersinia enterocolitica, Cryptosporidium parvum and Norovirus and they were selected to include at least one of each pathogen type (bacteria, parasite, virus), covering both detection methods (amplification and melt analysis).

None of the tested substances showed interference with the Xpert GI Panel test performance, except for overfilling of stool sample above the Cary Blair medium transport vial max fill line. The stool overfill condition resulted in five pressure errors, two false negative results for Cryptosporidium parvum and delayed Ct values for the amplification targets (EIEC, Cryptosporidium parvum and Norovirus). Thus, overfilling stool in the Cary Blair medium vial may be a potential risk for non-determinate results or false negative results at low target pathogen levels. These results highlight the importance of performing the stool sample collection correctly and according to the Cary Blair manufacturer's instructions.

Table 19: Potential Interfering Substances Study Results

| Type of Substance | Substance | Test Concentration in Raw Stool |
| --- | --- | --- |
| Endogenous Substances | Human whole blood | 10% v/v |
| | Mucin | 5% w/v |
| | Fecal fat – triglycerides | 5% v/v |
| | Fecal fat – cholesterol | 5% w/v |
| | Human stool (overfill of Cary Blair vial) | Filled above vial max fill line |
| | Bile Salts | 9 mg/g |
| | Human urine | 50% v/v |
| | Amoxicillin | 5% w/v |

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| Type of Substance | Substance | Test Concentration in Raw Stool |
| --- | --- | --- |
| Exogenous Substances | Ampicillin | 5% w/v |
| | Aspartame | 5% w/v |
| | Azithromycin | 1% w/v |
| | Bacitracin | 50% w/v |
| | Ceftriaxone | 16 mg/mL |
| | Ciprofloxacin | 5% w/v |
| | Doxycycline | 1% w/v |
| | Fluvastatin | 1% w/v |
| | Glycerin | 50% v/v |
| | Nystatin | 50% w/v |
| | Metronidazole | 60.8 mg/mL |
| | Vancomycin | 12.5 mg/mL |
| | Naproxen sodium | 10% w/v |
| | Bisacodyl | 5% w/v |
| | Bismuth subsalicylate | 1% w/v |
| | Calcium carbonate | 5% w/v |
| | Docusate sodium | 50% w/v |
| | Hydrocortisone | 50% w/v |
| | Loperamide hydrochloride | 5% w/v |
| | Magnesium hydroxide | 10% w/v |
| | Phenylephrine hydrochloride | 30% w/v |
| | Sodium phosphate | 5% w/v |
| | Nonoxynol-9 | 50% v/v |
| | Steric acid | 5% w/v |
| | Palmitic acid | 5% w/v |
| | Bleach 10% | 50% v/v |
| Ethanol | 0.2% v/v | |
| Mineral Oil | 50% v/v | |
| Method Specific Substance (Cary Blair Medium) | Copan Fecal Swab | N/A |
| | Remel Cary Blair | N/A |
| | Para-Pak C&S | N/A |
| | MCC C&S Medium Transport | N/A |

4. Assay Reportable Range:
Not applicable as this is a qualitative assay.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

a. Specimen Stability:

A specimen stability study was conducted using positive and negative samples in fresh clinical stool matrix to determine the stability of the Xpert GI Panel target pathogens in clinical stool matrix. The samples were tested at 2°C and 8°C for up to five days and at 15°C and 25°C for up to either 72 hours or 4 days. A minimum of eight replicates for each positive and negative sample were tested for each time point and temperature condition using one Xpert GI Panel reagent lot. All the Xpert GI Panel target pathogens were tested either as target mixes or as single

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targets in fresh clinical stool matrix at $\leq 3\mathrm{x}$ LoD. The negative sample consisted of fresh negative clinical stool without any Xpert GI Panel target pathogens.

The data from specimen stability support a specimen storage claim in clinical stool matrix (stool in Cary Blair) at $2^{\circ}\mathrm{C} - 8^{\circ}\mathrm{C}$ for up to 4 days and at $15^{\circ}\mathrm{C} - 25^{\circ}\mathrm{C}$ for up to 24 hours.

# 6. Detection Limit:

The analytical limit of detection (LoD) of the Xpert GI Panel test was determined by using two strains per Xpert GI Panel target pathogen. Each Xpert GI Panel target pathogen strain was serially diluted in clinical stool matrix and tested using two reagent lots across three testing days. The highest observed LoD, as determined by Probit regression analysis (95th Percentile), for each target pathogen strain from the two reagent lots was selected for LoD verification. Verification and confirmation of the estimated LoD for each Xpert GI Panel target pathogen strain was performed using one reagent lot across three testing days with a minimum of 20 replicates. The titer with a positive reported result greater than or equal to $95\%$ was determined as the verified LoD. The verified LoD was then confirmed by levels tested below and above with reported results of $< 95\%$ and $100\%$ respectively. The verified and confirmed LoD values for each Xpert GI Panel target pathogen strain are presented in Table 20.

Table 20: Limit of Detection of the Xpert GI Panel Analytes

| Target Pathogen | Strain | Strain ID | Confirmed LoD |
| --- | --- | --- | --- |
| Campylobacter | Campylobacter coli | CCUG 11283T | 46 CFU/mL |
| | Campylobacter jejuni | CCUG 41359 | 183 CFU/mL |
| Shigella/EIEC | Shigella sonnei | CCUG 68726T | 82 CFU/mL |
| | Enteroinvasive Escherichia coli | CCUG 46406 | 204 CFU/mL |
| | Salmonella bongori | CCUG 30042T | 261 CFU/mL |
| Salmonella | Salmonella enterica | NCTC 13171 | 1,242 CFU/mL |
| STEC stx1/stx2 | STEC stx1 | Statens Serum Institut MHI813 | 624 CFU/mL |
| | STEC stx2 | Statens Serum Institut 31 | 3,010 CFU/mL |
| | STEC stx1_2 | Statens Serum Institut EDL933 | 565 (stx1) CFU/mL |
| | STEC stx1_2 | Statens Serum Institut EDL933 | 683 (stx2) CFU/mL |
| Vibrio cholerae | Vibrio cholerae | NCTC 8457 | 136 CFU/mL |
| | Vibrio cholerae | CCUG 67718 | 459 CFU/mL |
| Vibrio parahaemolyticus | Vibrio parahaemolyticus | CCUG 14474T | 127 CFU/mL |
| | Vibrio parahaemolyticus | CCUG 67711 | 489 CFU/mL |
| Yersinia enterocolitica | Yersinia enterocolitica | CCUG 52867T | 348 CFU/mL |
| | Yersinia enterocolitica | CCUG 12369T | 106 CFU/mL |
| Cryptosporidium | Cryptosporidium hominis | Waterborne Inc. TU502 | 72 oocysts/mL |
| | Cryptosporidium parvum | Waterborne Inc. P102C, Iowa | 246 oocysts/mL |
| Giardia | Giardia lamblia | Waterborne Inc. P101, H3 | 246 cysts/mL |
| | Giardia intestinalis | ATCC 30957 | 0.36 cysts/mL |
| Norovirus | Norovirus GI | Clinical sample GI.3[P3] | 298 cp/mL |
| | Norovirus GII | Clinical sample GII.4 Sydney | 27 cp/mL |

# 7. Assay Cut-Off:

The Xpert GI Panel test detects 11 target pathogens, either from amplification analysis or melt curve analysis. The Xpert GI Panel test also detects two internal controls, one internal control

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(IC) detected by amplification analysis and one sample process control (SPC) detected by both amplification and melt analysis. The amplification signal is defined as the cycle threshold (Ct) when the amplification curve reaches the set threshold. The melt curve signal is defined as the temperature at which half of the DNA strands are in the random coil or single-stranded (ssDNA) state. Each target pathogen and internal control, within the cycle threshold or melt threshold values specifications are reported as POSITIVE. Each target pathogen and internal control, outside the cycle threshold or melt threshold values specifications are reported as NEGATIVE. If the SPC and/or the IC report a negative result, a test with a reported positive result for a target pathogen is reported as POSITIVE. If the SPC and/or IC report a negative result, a test with a reported negative result for all target pathogens is reported as INVALID. The cycle threshold and melt threshold specifications are included as automatic calculations in the assay definition file (ADF) of the Xpert GI Panel test.

## 8. Accuracy (Instrument):

Not applicable.

## 9. Carry-Over:

A study was conducted to demonstrate that the single-use, self-contained Xpert GI Panel cartridge exhibits no carry-over contamination. The carry-over contamination evaluation was conducted by testing a negative sample immediately after testing a positive sample at high concentration in the same GeneXpert module. This procedure was repeated until 10 high positive and 11 negative replicates had been alternately tested for two GeneXpert modules respectively. The positive sample consisted of representative target pathogens at high concentrations in clinical stool matrix, i.e., EIEC at 1E6 CFU/mL, Giardia lamblia at 1E5 cysts/mL and Norovirus at 1E5 cp/mL. The target pathogens were selected to include at least one of each pathogen type (bacteria, parasite, virus). The negative sample consisted of negative clinical stool matrix without any target pathogens. All 20 replicates of the positive sample (10 replicates for each GeneXpert module) were correctly reported as positive for the target pathogens included. All 22 replicates of the negative sample (11 replicates for each GeneXpert module) were correctly reported as Negative. Thus, no carry-over contamination in the GeneXpert modules were observed.

## B. Comparison Studies:

1. Method Comparison with Predicate Device:

Not applicable

2. Matrix Comparison:

Not applicable

## C. Clinical Studies:

1. Clinical Performance:

The clinical performance of the Xpert GI Panel was evaluated in a multicenter study at nineteen geographically diverse clinical sites within (13) and outside (6) of the United States. Clinical specimens were prospectively collected between July 2023 to December 2023. The clinical study utilized leftover, de-identified stool specimens in Cary Blair media collected from individuals suspected of GI infection. A total of 1658 prospectively collected fresh stool specimens in Cary Blair media were initially enrolled in the study of which only 1592 eligible specimens were

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included in the study. All clinical specimen testing using the Xpert GI Panel were performed by trained operators at 14 clinical testing sites.

Due to the low prevalence observed for specific analytes in the prospective study cohort, the sample size for this study was supplemented with pre-selected archived specimens sourced from sites within the United States. To minimize bias, pre-selected specimens were randomized and tested in a blinded manner at 5 of the 19 clinical sites. Pre-selected specimens were identified by standard of care results and confirmed using comparator test results prior to testing with the Xpert GI Panel. A total of 103 pre-selected specimens were included in the clinical performance analysis. In addition, if sufficient prospective and pre-selected archived specimens were not obtained for specific analytes, the sample size was supplemented with contrived samples for those analytes.

Overall initial and final non-determinant rates for Xpert GI panel clinical studies were 3.4% (74/2150) and 0.2% (4/2150), respectively.

## Prospective Specimens

Demographic information (sex, age, and healthcare setting) of the eligible prospective specimens is presented in Table 21.

Table 21: Demographics of Eligible Prospective Specimens

| Prospectively collected Fresh specimens (N=1592) | Number of specimens (%) |
| --- | --- |
| Sex | |
| Female | 907 (57.0%) |
| Male | 685 (43.0%) |
| Age (years) | |
| <18 | 187 (11.7%) |
| 18-21 | 29 (1.8%) |
| 22-49 | 398 (25.0%) |
| 50-64 | 344 (21.6%) |
| >=65 | 634 (39.8%) |
| Healthcare Setting | |
| ER Patient | 133 (8.4%) |
| Inpatient/Hospitalized | 338 (21.2%) |
| Outpatient | 569 (35.7%) |
| Unknown | 552 (34.7%) |

The clinical performance of each Xpert GI Panel analyte was compared to those of an FDA cleared molecular assay (Nucleic Acid Amplification Test) for most analytes. A composite of three FDA-cleared molecular assays was used for Campylobacter and Yersinia. Specimens were considered positive if at least two of the three comparator assays had positive results, and the specimens were considered negative if at least two of three comparator assays had negative results. A composite of 2 PCR assays followed by bi-directional sequencing was used for Norovirus. For STEC stx1, STEC stx2, and V. parahaemolyticus analytes, if the FDA cleared molecular assay was positive, a second FDA cleared molecular assay was performed to provide species differentiation. Specimens with discrepant results were investigated on an independent

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FDA cleared molecular assay. For each analyte in the Xpert GI Panel, the performance (Positive Percent Agreement (PPA), Negative Percent Agreement (NPA), and the 95% confidence interval (CI)) of the Xpert GI Panel as compared to the comparator method in prospective specimens is presented in Table 22. The number of specimens included in the performance calculations for each analyte were based on availability of valid results for Xpert GI Panel and the comparator method for the analyte and are presented in Table 22.

Table 22: Clinical Performance of Xpert Panel GI Test in Prospectively Collected Specimens

| Analyte | Total | Positive Percent Agreement | | | | Negative Percent Agreement | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | TP | FN | PPA (%) | 95%CI | TN | FP | NPA (%) | 95%CI |
| Campylobacter | 604 | 62 | 4^{a} | 93.9 | 85.4 - 97.6 | 533 | 5^{a} | 99.1 | 97.8 - 99.6 |
| Salmonella | 1568 | 49 | 5^{b} | 90.7 | 80.1 - 96.0 | 1512 | 2 | 99.9 | 99.5 - 100.0 |
| V. parahaemolyticus | 1505 | 0 | 0 | N/A | N/A | 1505 | 0 | 100.0 | 99.7 - 100.0 |
| V. cholerae | 1568 | 0 | 1^{c} | 0 | 0.0 - 79.3 | 1566 | 1^{c} | 99.9 | 99.6 - 100.0 |
| Yersinia | 603 | 15 | 0 | 100 | 79.6 - 100.0 | 578 | 10^{d} | 98.3 | 96.9 - 99.1 |
| Shigella EIEC | 1568 | 34 | 3^{e} | 91.9 | 78.7 - 97.2 | 1527 | 4^{e} | 99.7 | 99.3 - 99.9 |
| STEC stx1 | 1497 | 6 | 0 | 100.0 | 61.0 - 100.0 | 1491 | 0 | 100.0 | 99.7 - 100.0 |
| STEC stx2 | 1497 | 2 | 0 | 100.0 | 34.2 - 100.0 | 1494 | 1 | 99.9 | 99.6 - 100.0 |
| Cryptosporidium | 1568 | 32 | 0 | 100.0 | 89.3 - 100.0 | 1534 | 2^{f} | 99.9 | 99.5 - 100.0 |
| Giardia | 1568 | 20 | 1^{g} | 95.2 | 77.3 - 99.2 | 1543 | 4^{g} | 99.7 | 99.3 - 99.9 |
| Norovirus GI/GII | 1521 | 46 | 1 | 97.9 | 88.9 - 99.6 | 1448 | 26 | 98.2 | 97.4 - 98.8 |

Abbreviations: CI, confidence interval; FN, false negative; FP, false positive; N/A, not available; NPA, negative percent agreement; PPA, positive percent agreement; TN, true negative; TP…