Panther Fusion GI Expanded Bacterial Assay

K251993 · Hologic, Inc. · PCH · Sep 25, 2025 · Microbiology

Device Facts

• Record ID: K251993
• Device Name: Panther Fusion GI Expanded Bacterial Assay
• Applicant: Hologic, Inc.
• Product Code: PCH · Microbiology
• Decision Date: Sep 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3990
• Device Class: Class 2

Indications for Use

The Panther Fusion GI Expanded Bacterial Assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides. Nucleic acids are isolated and purified from Cary-Blair preserved stool specimens collected from individuals exhibiting signs and symptoms of gastroenteritis. This assay is intended to aid in the differential diagnosis of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides infections. The results of this assay should be used in conjunction with clinical presentation, laboratory findings, and epidemiological information 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 other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. 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. This assay is designed for use on the Panther Fusion System.

Device Story

The Panther Fusion GI Expanded Bacterial Assay is a multiplex real-time PCR test for detecting bacterial DNA in Cary-Blair preserved stool. The Panther Fusion System automates the entire workflow: specimen lysis, nucleic acid capture using magnetic particles, elution, and real-time PCR amplification. The system uses specific primers and probes to target InvA (Yersinia), gyrB (Vibrio), rfbE (E. coli O157), and hugA (Plesiomonas). Fluorescence signals are compared to a predetermined cutoff to provide qualitative results. The device is intended for clinical laboratory use to aid in the differential diagnosis of gastroenteritis. Results are interpreted by healthcare providers alongside clinical and epidemiological data. The system includes an internal control to monitor processing and amplification. It provides automated, high-throughput testing, reducing manual handling and potential for contamination.

Clinical Evidence

Multicenter study of 1,894 evaluable specimens (1,523 prospective, 182 retrospective, 189 contrived). Compared against PCR/sequencing or FDA-cleared NAAT. Results showed high PPA/NPA across all targets (Yersinia, Vibrio, STEC O157, Plesiomonas). Prospective PPA ranged from 50% (Vibrio, n=1) to 100% (STEC O157, Plesiomonas); NPA was >99% for all. Analytical studies confirmed LoD, inclusivity, and lack of cross-reactivity/interference.

Technological Characteristics

Multiplex real-time PCR; automated nucleic acid extraction via magnetic particles. Targets: InvA (Yersinia), gyrB (Vibrio), ompW (V. cholerae), rfbE (E. coli O157), hugA (Plesiomonas). Detection via fluorescence (FAM, HEX, ROX, RED647, RED677). System: Panther Fusion (fully automated). Connectivity: Standalone instrument. Reagents: Lyophilized master mix, capture/elution buffers.

Indications for Use

Indicated for the qualitative detection and differentiation of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides in Cary-Blair preserved stool specimens from individuals with signs and symptoms of gastroenteritis. For prescription use only.

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 Panel (GI) for use with FilmArray Torch (K160459)

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
K251993

B Applicant
Hologic Inc.

C Proprietary and Established Names
Panther Fusion GI Expanded Bacterial Assay

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 |
| OOI | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |

## II Submission/Device Overview:

### A Purpose for Submission:
To obtain substantial equivalence determination for the Panther Fusion Expanded GI Bacterial Assay on the Panther Fusion System using preserved Cary-Blair stool specimens.

### B Measurand:
Target DNA sequences with the Panther Fusion GI Expanded Bacteria Panel:
- Yersinia enterocolitica,
- Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae),
- Escherichia coli O157, and
- Plesiomonas shigelloides

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

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C Type of Test:
The Panther Fusion GI Expanded Bacterial Assay is a qualitative multiplex real time polymerase chain reaction (PCR) assay for the amplification and detection of DNA from Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides.

III Intended Use/Indications for Use:

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

B Indication(s) for Use:
The Panther Fusion GI Expanded Bacterial Assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides. Nucleic acids are isolated and purified from Cary-Blair preserved stool specimens collected from individuals exhibiting signs and symptoms of gastroenteritis.

This assay is intended to aid in the differential diagnosis of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides infections. The results of this assay should be used in conjunction with clinical presentation, laboratory findings, and epidemiological information 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 other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. 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. This assay is designed for use on the Panther Fusion System.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

D Special Instrument Requirements:
Panther Fusion System

IV Device/System Characteristics:

A Device Description:
The Panther Fusion GI Expanded Bacterial Assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides. Nucleic acids are isolated and purified from Cary-Blair preserved stool specimens collected from individuals exhibiting signs and symptoms of gastroenteritis.

The Panther Fusion System fully automates specimen processing, including sample lysis, nucleic acid capture, amplification, and detection for the Panther Fusion GI Expanded Bacterial Assay. Nucleic acid capture and elution takes place in a single tube on the Panther Fusion System. The eluate is transferred to the Panther Fusion System reaction tube containing the assay reagents.

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Multiplex real-time PCR is then performed for the eluted nucleic acid on the Panther Fusion System.

## B Principle of Operation:

### Sample Collection and Transfer

Prior to processing and testing on the Panther Fusion System, Cary-Blair preserved stool (CBS) sample is transferred into an Aptima Multitest tube containing 2.9 mL of specimen transport media (STM) by using Aptima multi-test specimen collection kit swab. The amount of CBS transferred by a swab is approximately 150μL, equating to a 1:20 dilution of the CBS sample. The sample transport tube is placed on the Panther Fusion and 360μL of the sample is transferred into a multi-tube unit (MTU) to undergo lysis and target capture.

### Lysis, Nucleic Acid Capture and Elution

Specimen transport media (STM) lyses the cells, releases target nucleic acid and protects them from degradation during storage. Additionally, specimens are subjected to further lysis with Panther Fusion Enhancer Reagent-B (FER-B). The Internal Control (IC) is added to each test specimen and controls via the working Panther Fusion Capture Reagent (wFCR). The IC in the reagent monitors specimen processing, amplification and detection. Capture oligonucleotides hybridize to nucleic acid in the test specimen. Hybridized nucleic acid is then separated from the specimen in a magnetic field. Wash steps remove extraneous components from the reaction tube. The elution step elutes purified nucleic acid. During the nucleic acid capture and elution step, total nucleic acid is isolated from specimens.

### Elution Transfer and Multiplex PCR

During the elution transfer step, eluted nucleic acid is transferred to a Panther Fusion reaction tube already containing oil and reconstituted master mix. Target amplification occurs by PCR. Target specific forward and reverse primers and probes then amplify targets while simultaneously detecting and discriminating multiple target types via multiplex PCR. The Panther Fusion system compares the fluorescence signal to a predetermined cut-off to produce a qualitative result for the presence or absence of the analyte. The analytes and the channel used for their detection on the Panther Fusion system are summarized in the table below.

Table 1. Summary of analytes detected by the Panther Fusion GI Expanded Bacterial Assay and channels for their detection on the Panther Fusion system

| Analyte | Gene Targeted | Instrument Channel |
| --- | --- | --- |
| Yersinia enterocolitica | InvA (Invasive antigen A) | FAM |
| Vibrio parahaemolyticus | gyrB (Gyrase B) | HEX |
| Vibrio vulnificus | gyrB (Gyrase B) | HEX |
| Vibrio cholerae | ompW (Outer Membrane Protein W) | HEX |
| Escherichia coli O157 | rfbE (Perosamine synthase-O-antigen) | ROX |
| Plesiomonas shigelloides | hugA (Heme utilization gene A) | RED647 |
| Internal Control | Not Applicable | RED677 |

### Kit Components

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The reagents required to perform the Panther Fusion GI Expanded Bacterial Assay are packaged and sold separately. There are seven boxes containing nine reagents which are required for sample processing.

- Box 1: Panther Fusion GI Expanded Bacterial Assay Cartridges – 96 Tests (P/N PRD-07121). Contains eight Panther Fusion GI Expanded Bacterial Assay Cartridges - individually pouched in foil containing one desiccant (12 tests per cartridge). Storage at 2° – 8°C. Each well contains lyophilized, unit dose, assay specific, master mix required for PCR reaction.
- Box 2: Panther Fusion Extraction Reagent-B – 960 Tests (P/N PRD-06232). Contains:
- Four Panther Fusion Capture Reagent-B bottles (240 tests per bottle). Storage at 15° – 30°C. buffered salt solution containing solid phase (magnetic particles) and non-infectious nucleic acids.
- Four Panther Fusion Enhancer Reagent-B bottles (240 tests per bottle). Storage at 15° – 30°C. To enhance the disruption of bacterial particles and denaturation of nucleic acids that may be present in sample.
- Box 3: Panther Fusion Internal Control-B - 960 Tests (P/N PRD-06234). Contains four Panther Fusion Internal Control-B bottles. Storage at 2° – 8°C. Added to each reaction to determine validity of each individual reaction.
- Box 4: Panther Fusion Reconstitution Buffer I – 1920 Tests – (P/N PRD-04333). Storage at 15° – 30°C.
- Box 5: Panther Fusion Elution Buffer – 2400 Tests – (P/N PRD-04334). Storage at 15° – 30°C.
- Box 6: Panther Fusion Oil – 1920 Tests – (P/N PRD-04335). Storage at Storage at 15° – 30°C.
- Box 7: Panther Fusion GI Expanded Bacterial Assay Controls – 5 Tests (P/N PRD-07122). Storage at 2° – 8°C. Contains:
- Five Panther Fusion GI Expanded Bacterial Positive Control tubes (single use). To validate the accuracy of the calibration curve
- Five Panther Fusion GI Expanded Bacterial Negative Control tubes (single use). Controls for any potential contaminations of reagents or environment.

The Panther Fusion GI Expanded Bacterial Assay requires one ancillary kit and one specimen collection kit, neither of which are provided with the assay and can be acquired separately:

1) Aptima Assay Fluids Kit (303014)
2) Aptima Multitest Swab Specimen Collection Kit (PRD-03546)

Additionally, the Panther Fusion Reconstitution Buffer I, Elution Buffer, and Oil Reagents are universally used for all Panther Fusion system assays. The Elution Buffer and Oil Reagents may also be bundled and ordered under the Panther Fusion Universal Fluids Kit.

C Instrument Description Information:

1. Instrument Name:
Panther Fusion

2. Specimen Identification:
A barcode reader reads the barcodes assigned to the specimens.

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3. Specimen Sampling and Handling:
Stool specimens are collected from patients using commercially available collection kits and transferred into Cary-Blair media. The stool is diluted approximately 1:3 in Cary-Blair media following the instructions given by the Cary Blair manufactures. The Cary-Blair preserved stool (CBS) sample is then transferred into an Aptima Multitest tube containing 2.9 mL of specimen transport media (STM) by using Aptima multi-test specimen collection kit swab into the CBS. The amount of CBS transferred by a swab is approximately 150 μL, equating to a 1:20 dilution of the CBS sample. The sample transport tube is placed on the Panther Fusion and 360 μL of the sample is transferred into a multi-tube unit (MTU) to undergo lysis and target capture.

4. Calibration:
The instrument is calibrated by the manufacturer on-site as part of the installation procedure.

5. Quality Control:
To generate valid results, the Panther Fusion GI Expanded Bacterial Assay uses internal and external controls:
- Internal control (IC) is added to each test specimen and controls via the working Panther Fusion Capture Reagent (wFCR). The IC in the reagent monitors specimen processing, amplification and detection.
- Assay Controls: Two types of controls are provided by Hologic to the user: one negative control; and one positive control that contains inactivated Yersinia enterocolitica cells and plasmids for other targets. One replicate of the negative assay control and one replicate of positive assay control must be tested each time a new lot of assay cartridges is loaded on the system or when the current set of valid controls for an active cartridge lot have expired.

The Panther system is configured to require assay controls run at an administrator-specified interval of up to 30 days. During processing, the internal control acceptance criteria is automatically verified by the Panther Fusion system software. Detection of the internal control is not required for samples that are positive for Yersinia enterocolitica, Vibrio species, Escherichia coli O157, and Plesiomonas shigelloides. The internal control must be detected in all samples that are negative for all intended analytes. Samples that fail to meet that criteria will be reported as Invalid. Each sample with an Invalid result must be retested. Both types of controls must generate results within predefined specifications to be valid.

V Substantial Equivalence Information:

A Predicate Device Name(s):
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

B Predicate 510(k) Number(s):
K160459

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K251993 | K160459 |
| --- | --- | --- |
| Device Trade Name | Hologic Panther Fusion GI Expanded Bacterial Assay | BioFire FilmArray Gastrointestinal (GI) Panel |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Panther Fusion GI Expanded Bacterial Assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides. Nucleic acids are isolated and purified from Cary-Blair preserved stool specimens collected from individuals exhibiting signs and symptoms of gastroenteritis. This assay is intended to aid in the differential diagnosis of Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides infections. The results of this assay should be used in conjunction with clinical presentation, laboratory findings, and epidemiological information 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 other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. 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. This assay is designed for use on the Panther Fusion System | The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. 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 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) · Shigella/Enteroinvasive Escherichia coli (EIEC) · Cryptosporidium · Cyclospora cayetanensis · Entamoeba histolytica |

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| | | • 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) |
| --- | --- | --- |
| | | The FilmArray GI Panel 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 FilmArray GI Panel. 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 E. coli O157, Plesiomonas shigelloides, Yersinia enterocolitica, Astrovirus, and Rotavirus A were established primarily with retrospective clinical specimens. |
| | | Performance characteristics for Entamoeba histolytica, and Vibrio (V. parahaemolyticus, V. vulnificus, and Vibrio cholerae) were established primarily using contrived clinical specimens. |
| | | Negative FilmArray GI Panel 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 noninfectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn’s disease. |

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| | | A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. |
| --- | --- | --- |
| Technology | Fully automated nucleic acid amplification, detection and result interpretation (multiplex PCR) | Same |
| Specimen type | Human stool in Cary Blair transport medium | Same |
| Sample preparation | Automated sample processing | Same |
| **General Device Characteristic Differences** | | |
| Analyte | DNA | DNA/RNA |
| Organisms detected | Yersinia enterocolitica, Vibrio (V. parahaemolyticus, V. vulnificus, V. cholerae), Escherichia coli O157, and Plesiomonas shigelloides | 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), Shigella/Enteroinvasive Escherichia coli (EIEC), 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) |
| Amplification mode | Real Time PCR | Nested multiple PCR |
| Detection Mode | Fluorogenic target-specific hybridization | Fluorogenic double stranded DNA binding dye |
| Instrumentation | Panther Fusion System | BioFire Film Array Systems |
| Time to Results | Approximately 2.4 hours | Approximately 1 hour |
| Controls | Internal control in each sample. External control processed at periodic interval | Two controls are included in each reagent pouch to control for sample processing and both stages of PCR and melt analysis. |

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VI Standards/Guidance Documents Referenced:

Special Controls and Guidance Documents:
- 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 2015)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Guidance for Industry and Food and Drug Administration Staff, July 2014

Standards
- CLSI EP07 3rd Edition. Interference Testing in Clinical Chemistry.
- CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.
- CLSI EP12 3rd Edition. Evaluation of Qualitative Binary Output Examination Performance.
- CLSI EP17-A2. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition.
- CLSI EP24-A2. Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition. (Replaces GP10-A)
- CLSI EP25. Evaluation of Stability of in vitro Medical Laboratory Test Reagents. 2nd Edition.
- CLSI MM03 3rd Edition. Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline. 2nd Edition. (Replaces MM03-A2).
- CLSI EP37. Supplemental Tables for Interference Testing in Clinical Chemistry. 1st Edition.
- ISO 15223-1 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements. Fourth Edition 2021-07.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:
1. Precision: Within-laboratory precision for the Panther Fusion GI Expanded Bacterial Assay was evaluated at one internal site, using three lots of reagents on three instruments by three operators, and each operator performed two runs per day. Testing was conducted over nine days extended over 22 calendar days. Each sample was tested with three replicates in each run, for a total of 162 replicates per sample. The study included a panel of five samples: (1) negative sample, (2) low positive sample with Yersinia enterocolitica at 1.5x LoD, (3) moderate positive sample with Yersinia enterocolitica at 3xLoD, (4) low positive sample with Vibrio, STEC O157, and Plesiomonas shigelloides at 1.5xLoD, and (5) moderate positive sample with Vibrio, STEC O157, and Plesiomonas shigelloides at 3xLoD. All panel samples were generated in Cary-Blair Stool (CBS) matrix. All five samples were in 100% agreement with the expected results. Within-laboratory precision study results are summarized in table 2 below.

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Table 2. Precision Study Results.

| Panel | Description | Analyte | Agreed/Total | Agreement % | Mean Ct | Between Lots | | Between Instruments | | Between Operators | | Between Days | | Between Runs | | Within Run | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| 1 | Negative | Negative (Internal Control) | 162/162 | 100 | 34.6 | 0.07 | 0.2 | 0.08 | 0.23 | 0.04 | 0.12 | 0.00 | 0.00 | 0.00 | 0.00 | 0.48 | 1.39 | 0.5 | 1.43 |
| 2 | Low Pos (1.5X LoD) | Yersinia | 162/162 | 100 | 33.7 | 0.03 | 0.08 | 0.09 | 0.26 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.41 | 1.23 | 0.42 | 1.26 |
| 3 | Mod Pos (1.5X LoD) | Yersinia | 162/162 | 100 | 33.7 | 0.12 | 0.35 | 0.07 | 0.21 | 0.01 | 0.04 | 0.00 | 0.00 | 0.17 | 0.52 | 0.23 | 0.69 | 0.32 | 0.95 |
| 4 | Low Pos (1.5X LoD) | Vibrio | 162/162 | 100 | 32.7 | 0.07 | 0.21 | 0.12 | 0.37 | 0.00 | 0.00 | 0.00 | 0.00 | 0.19 | 0.57 | 0.2 | 0.6 | 0.3 | 0.93 |
| | | STEC O157 | 162/162 | 100 | 32.4 | 0.02 | 0.08 | 0.04 | 0.13 | 0.00 | 0.00 | 0.00 | 0.00 | 0.11 | 0.34 | 0.28 | 0.87 | 0.31 | 0.95 |
| | Plesiomonas | 162/162 | 100 | 31.3 | 0.02 | 0.08 | 0.06 | 0.2 | 0.00 | 0.00 | 0.03 | 0.1 | 0.00 | 0.00 | 0.21 | 0.68 | 0.22 | 0.72 | |
| 3 | Mod Pos (3X LoD) | Vibrio | 162/162 | 100 | 33.8 | 0.08 | 0.25 | 0.05 | 0.14 | 0.00 | 0.00 | 0.00 | 0.00 | <0.01 | 0.03 | 0.25 | 0.73 | 0.26 | 0.78 |
| | | STEC O157 | 162/162 | 100 | 33.1 | 0.05 | 0.17 | <0.01 | 0.03 | 0.01 | 0.03 | 0.06 | 0.17 | 0.00 | 0.00 | 0.19 | 0.56 | 0.2 | 0.61 |
| | Plesiomonas | 162/162 | 100 | 28 | 0.11 | 0.39 | 0.32 | 1.15 | 0.00 | 0.00 | 0.00 | 0.00 | 0.12 | 0.42 | 0.14 | 0.51 | 0.39 | 1.39 | |

Ct = cycle threshold, CV = coefficient of variation, Mod = Moderate, N = sample size, Pos = positive, SD = standard deviation.
${}^{a}$ Agreement to expected panel positivity result.

2. Reproducibility: Reproducibility for the Panther Fusion GI Expanded Bacterial Assay was evaluated at three U.S. clinical testing sites. Testing was performed using one Panther Fusion System at each site and the Panther Fusion GI expanded Bacterial Assay Controls. The study included the same sample panel tested during the within-laboratory precision. Testing was conducted by two operators per site over at least five days using one reagent lot. Each operator tested each panel member in replicates of three in each run for a total of 90 replicates per panel member. All sample panels showed $100\%$ agreement with the expected results. Study results are summarized in tables below.

Table 3. Reproducibility Study: Overall Agreement

| Target | Concentration1 | Expected Result | Agreed/N | Agreement (%) 95% CI2 |
| --- | --- | --- | --- | --- |
| Yersinia | Negative | Negative | 89/89 | 100 (95.9-100) |
| | Low Positive | Positive | 90/90 | 100 (95.9-100) |
| | Mod Positive3 | Positive | 90/90 | 100 (95.9-100) |
| Vibrio | Negative | Negative | 89/89 | 100 (95.9-100) |
| | Low Positive | Positive | 90/90 | 100 (95.9-100) |
| | Mod Positive | Positive | 90/90 | 100 (95.9-100) |
| O157 | Negative | Negative | 89/89 | 100 (95.9-100) |
| | Low Positive | Positive | 90/90 | 100 (95.9-100) |
| | Mod Positive | Positive | 90/90 | 100 (95.9-100) |
| Plesiomonas | Negative | Negative | 89/89 | 100 (95.9-100) |
| | Low Positive | Positive | 90/90 | 100 (95.9-100) |
| | Mod Positive | Positive | 90/90 | 100 (95.9-100) |

Mod = moderate.

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The concentration category of 'negative' only includes results from the negative panel member (i.e., matrix only).
2Score CI.
3There was one positive Vibrio result on the Yersinia moderate positive panel.

Table 4. Reproducibility Study: Signal Variability of the Panther Fusion GI Expanded Bacterial Assay.

| | | | Between Site | | | Between Operator/Run- | | Between Day | | Within Run | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Description | Analyte | N | Mean Ct | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Low Posa | Yersinia | 90 | 34.7 | 0.17 | 0.50 | 0.21 | 0.61 | 0.09 | 0.27 | 0.44 | 1.25 | 0.52 | 1.51 |
| | Vibrio | 90 | 33.7 | 0.16 | 0.49 | 0.08 | 0.25 | 0.00 | 0.00 | 0.26 | 0.77 | 0.32 | 0.95 |
| | STEC O157 | 90 | 32.4 | 0.17 | 0.53 | 0.13 | 0.41 | 0.00 | 0.00 | 0.30 | 0.92 | 0.37 | 1.14 |
| | Plesiomonas | 90 | 33.9 | 0.16 | 0.47 | 0.06 | 0.17 | 0.00 | 0.00 | 0.32 | 0.94 | 0.36 | 1.06 |
| Mod Posb | Yersinia | 90 | 33.8 | 0.35 | 1.03 | 0.19 | 0.58 | 0.07 | 0.21 | 0.37 | 1.08 | 0.55 | 1.61 |
| | Vibrio | 90 | 32.7 | 0.20 | 0.60 | 0.09 | 0.26 | 0.11 | 0.35 | 0.22 | 0.68 | 0.33 | 1.01 |
| | STEC O157 | 90 | 31.4 | 0.24 | 0.75 | 0.08 | 0.27 | 0.07 | 0.21 | 0.26 | 0.81 | 0.36 | 1.16 |
| | Plesiomonas | 90 | 33.2 | 0.22 | 0.67 | 0.12 | 0.37 | 0.00 | 0.00 | 0.26 | 0.78 | 0.36 | 1.09 |

Ct = cycle threshold, CV = coefficient of variation, Mod = moderate, N = sample size, Pos = positive, SD = standard deviation. Note: The analysis was performed using the SAS MIXED procedure, which applies a lower boundary of 0 to all variance components in the model by default. If a variance component is 0, SD, and %CV are displayed as 0.00
a Low Pos = All targets are 1.5X LoD.
b Mod Pos = All targets are 3X LoD.
c Between Operator may be confounded with Between Run; therefore, Between Operator and Between Run estimates are combined in Between Operator/Run.

Table 5. Reproducibility Study: Signal variability of the Panther Fusion GI Expanded Bacterial Assay Positive Control.

| | | | Between Site | | | Between Operator | | Between Day | | Within Day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Control | Analyte | N | Mean Ct | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| Pos | Yersinia | 30 | 32.7 | 0.22 | 0.66 | 0.00 | 0.00 | 0.00 | 0.00 | 0.25 | 0.75 | 0.33 | 1.01 |
| | Vibrio | 30 | 33.4 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.29 | 0.86 | 0.29 | 0.86 |
| | STEC O157 | 30 | 31.5 | 0.11 | 0.35 | 0.00 | 0.00 | 0.07 | 0.23 | 0.26 | 0.83 | 0.29 | 0.93 |
| | Plesiomonas | 30 | 32.9 | 0.05 | 0.16 | 0.08 | 0.23 | 0.12 | 0.37 | 0.24 | 0.74 | 0.29 | 0.87 |

Ct = cycle threshold, CV = coefficient of variation, N = sample size, Pos = positive, SD = standard deviation.
Note: The analysis was performed using the SAS MIXED procedure, which applies a lower boundary of 0 to all variance components in the model by default. If a variance component is 0, SD and %CV are displayed as 0.00.

3. Linearity:

Not applicable.

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# 4. Analytical Specificity/Interference:

# Cross-reactivity

Cross-reactivity and microbial interference for the Panther Fusion GI Expanded Bacterial Assay were evaluated in the presence of non-targeted microorganisms that are either phylogenetically related to the assay analytes or potentially found in clinical specimens. Panels, consisting of 109 bacteria, viruses, parasites, and yeast (listed in Table 6), were tested in negative CBS matrix in the absence and in the presence of GI Expanded Bacterial Assay analytes at $3\mathrm{x}$ LoD. Except where noted, bacteria, yeast, and parasites were evaluated at $10^{6}$ CFU/mL or $10^{6}$ rRNA copies/mL or $10^{6}$ cells/mL; viruses were evaluated at $10^{5}$ TCID50/mL. If cross-reactivity or interference was observed in the initial testing, then the organism was tested at lower concentrations until the expected result was observed. No cross-reactivity or microbial interference was observed with any of the organisms tested on the Panther Fusion GI Expanded Bacterial Assay at the indicated concentrations.

Table 6. Microorganisms tested for Cross-Reactivity and Microbial Interference

| Microorganism | Test Concentration | Microorganism | Test Concentration |
| --- | --- | --- | --- |
| Arcobacter cryaerophilus | 10^6 CFU/mL | Entercoccus faecalis | 10^6 CFU/mL |
| Neisseria gonorrhoeae | 10^6 CFU/mL | Enterobacter aerogenes | 10^6 CFU/mL |
| Streptococcus pyogenes | 10^6 CFU/mL | Enterobacter cloacae | 10^6 CFU/mL |
| Trabulsiella guamensis | 10^6 CFU/mL | Escherichia fergusonii | 10^6 CFU/mL |
| Faecalibacterium prausnitzii | 10^6 rRNA copies /mL | Escherichia hermanii | 10^6 CFU/mL |
| Escherichia coli (non-shigatoxigenic) | 10^6 CFU/mL | Escherichia vulneris | 10^6 CFU/mL |
| Giardia lamblia BG-Aa | 10^6 copies/mL | Gardnerella vaginalis | 10^6 CFU/mL |
| Cyclospora | 10^6 copies/mL | Helicobacter pylori | 10^6 CFU/mL |
| Cryptosporidium | 10^6 copies/mL | Klebsiella oxytoca | 10^6 CFU/mL |
| Norovirus (Noro GII)a | 10^6 copies/mL | Klebsiella ozaenae | 10^6 CFU/mL |
| Astrovirus | 10^6 copies/mL | Klebsiella pneumoniae | 10^6 CFU/mL |
| Sapovirus (GII)a | 10^5 copies/mL | Lactobacillus acidophilus | 10^6 CFU/mL |
| Enterovirus (Ent V)a | 10^5 copies/mL | Lactobacillus crispatus | 10^6 CFU/mL |
| Rhinovirusa | 10^5 copies/mL | Lactococcus lactis | 10^6 CFU/mL |
| Coronavirus 229E | 10^5 TCID50/mL | Listeria grayi | 10^6 CFU/mL |
| Coxsakeivirus Type B4 | 10^5 TCID50/mL | Listeria monocytogenes | 10^6 CFU/mL |
| Adenovirus Type 7A | 10^5 TCID50/mL | Morganella morganii | 10^6 CFU/mL |
| Rotavirusa | 10^5 copies/mL | Peptostreptococcus anaerobius | 10^6 CFU/mL |
| Anaerococcus tetradius | 10^6 CFU/mL | Peptostreptococcus micros | 10^6 rRNA copies /mL |
| Abiotrophia defectivia | 10^6 CFU/mL | Photobacterium damselae | 10^6 CFU/mL |
| Acinetobacter baumannii | 10^6 CFU/mL | Prevotella bivia | 10^6 CFU/mL |
| Acinetobacter lwoffii | 10^6 CFU/mL | Prevotella melaninogenica | 10^6 CFU/mL |
| Aeromonas hydrophila | 10^6 CFU/mL | Proteus mirabilis | 10^6 rRNA copies /mL |
| Alcaligenes faecalis | 10^6 CFU/mL | Proteus penneri | 10^6 CFU/mL |
| Campylobacter upsaliensis | 10^6 CFU/mL | Proteus vulgaris | 10^6 CFU/mL |
| Anaerococcus vaginalis | 10^6 CFU/mL | Providencia alcalifaciens | 10^6 CFU/mL |
| Arcobacter butzleri | 10^6 CFU/mL | Providencia rettgeri | 10^6 CFU/mL |

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| Microorganism | Test Concentration | Microorganism | Test Concentration |
| --- | --- | --- | --- |
| Bacillus cereus | 10^6 CFU/mL | Providencia stuartii | 10^6 CFU/mL |
| Bacteriodes fragilis | 10^6 CFU/mL | Pseudomonas aeruginosa | 10^6 CFU/mL |
| Bacteroides thetaiotaomicron | 10^6 CFU/mL | Pseudomonas fluorescens | 10^6 CFU/mL |
| Bacteroides vulgatus | 10^6 CFU/mL | Serratia liquefaciens | 10^6 CFU/mL |
| Bifidobacterium adolescentis | 10^6 CFU/mL | Serratia marcescens | 10^6 CFU/mL |
| Bifidobacterium longum | 10^6 rRNA copies /mL | Staphylococcus aureus | 10^6 CFU/mL |
| Campylobacter fetus | 10^6 CFU/mL | Staphylococcus epidermidis | 10^6 CFU/mL |
| Campylobacter hyointestinalis | 10^6 CFU/mL | Stenotrophomonas maltophilia | 10^6 CFU/mL |
| Campylobacter rectus | 10^6 CFU/mL | Streptococcus anginosus | 10^6 CFU/mL |
| Campylobacter sputorum | 10^6 CFU/mL | Streptococcus dysgalactiae | 10^6 CFU/mL |
| Candida albicans | 10^6 CFU/mL | Yersinia bercovieri | 10^6 CFU/mL |
| Citrobacter freundii | 10^6 CFU/mL | Yersinia pseudotuberculosis | 10^6 CFU/mL |
| Citrobacter koseri | 10^6 CFU/mL | Yersinia rohdei | 10^6 CFU/mL |
| Clostridium difficile | 10^6 CFU/mL | Campylobacter lari | 10^6 CFU/mL |
| Clostridium perfringens | 10^6 CFU/mL | Entamoeba histolytica | 10^4 cells/mL |
| Clostridium ramosum | 10^6 CFU/mL | Megasphaera elsdenii | 10^6 CFU/mL |
| Clostridium sordellii | 10^6 CFU/mL | Chlamydia trachomatis | 10^5 IFU/mL |
| Clostridium tertium | 10^6 CFU/mL | Leptotrichia buccalis | 10^6 CFU/mL |
| Collinsella aerofaciens | 10^6 CFU/mL | Cytomegalovirus | 10^5 TCID50/mL |
| Corynebacterium genitalium | 10^6 CFU/mL | Salmonella enterica | 10^6 CFU/mL |
| Cronobacter sakazakii | 10^6 CFU/mL | Campylobacter jejuni | 10^6 CFU/mL |
| Edwardsiella tarda | 10^6 CFU/mL | Shigella sonnei | 10^6 CFU/mL |
| Egglerthella lenta | 10^6 rRNA copies /mL | STEC - stx1 | 10^6 CFU/mL |
| STEC - stx2 | 10^6 CFU/mL | Vibrio mimicus | 10^6 CFU/mL |
| Vibrio fluvialis | 10^6 CFU/mL | Yersinia frederiksenii | 10^6 CFU/mL |
| Vibrio furnissii | 10^6 CFU/mL | Yersinia kristensenii | 10^6 CFU/mL |
| Vibrio metschnikovii | 10^6 CFU/mL | Vibrio alginolyticus^k | 10^4 CFU/mL |

CFU = colony forming units, IFU = inclusion forming units, rRNA copies = ribosomal ribonucleic acid copies, TCID50 = Median Tissue Culture Infectious Dose.
a In vitro transcripts were used to evaluate cross-reactivity and microbial interference as cultured virus or whole genome purified nucleic acid are not readily available.
$b$ Cross reactivity was observed at concentrations $\geq 10^{5}$ CFU/mL.

# Inclusivity/Reactivity

The inclusivity/reactivity of the Panther Fusion GI Expanded Bacterial Assay was determined by testing multiple bacterial strains for each of the intended analytes in negative CBS matrix. Each strain was tested in triplicate at 3x LoD with 1 reagent lot in single or multi-analyte configuration. Vibrio vulnificus ATCC# CCUG 38297 strain was not detected at 3x LoD and additional testing at higher concentrations was performed until $100\%$ positivity was observed at 5x LoD. Table 7 shows the lowest concentration of each strain at which $100\%$ positivity was observed.

Table 7. Summary of inclusivity/reactivity study results.

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| Organism | ATCC# or Source | Strain/ serovar/ serotype/ antigenic properties | Test Concentration (3xLoD) (CFU/mL) |
| --- | --- | --- | --- |
| Optima Multitest Tube | Preserved Stool |
| Yersinia enterocolitica | BEI NR-207 | CDC 497-70, O:8 | 282 | 5,640 |
| BEI NR-212 | NCTC 11175, O:3 | 282 | 5,640 |
| 23715 | Billups-1803-68, O:8 | 282 | 5,640 |
| 49397 | 1375, O:8c | 282 | 5,640 |
| NCTC 10463 | P 77, O:5, 27 | 282 | 5,640 |
| CCUG 4588 | Type 2, O:9 | 282 | 5,640 |
| CCUG 8050 | N/A | 282 | 5,640 |
| CCUG 8232 | Type 5, O:1, 2, 3 | O:2, 3 | O:3/XI | 282 | 5,640 |
| CCUG 8234 | Type 4 | 282 | 5,640 |
| 55075 | O:9 | 282 | 5,640 |
| 27729 | WA, Type 1, O:8 | 282 | 5,640 |
| Vibrio parahaemolyticus | BEI NR-21990 | 48057, O4: K12 | 270 | 5,400 |
| BEI NR-21992 | KXV 755, O4: K41 | 270 | 5,400 |
| BAA-242 | VP250, O1:KUT | 270 | 5,400 |
| 27969 | FC 1011 | 270 | 5,400 |
| BAA-241 | VP232, O4:K68 | 270 | 5,400 |
| 33845 | 117 [CDC KC830] | 270 | 5,400 |
| 43996 | NCTC 10884 [70/116655] | 270 | 5,400 |
| 33846 | 205 [9302] | 270 | 5,400 |
| 49529 | MDL 3875-7-83, O4:K12 | 270 | 5,400 |
| CCUG 34902 | N/A | 270 | 5,400 |
| CCUG 67711 | N/A | 270 | 5,400 |
| 33847 | 279 [11590] | 270 | 5,400 |
| Vibrio vulnificus | 33817 | 329 [CDC B3547], Biotype 2 | 33 | 660 |
| BAA-86 | CDC 9505-95 | 33 | 660 |
| CCUG 38297 | N/A | 33 | 660 |
| CCUG 47321 | N/A | 33 | 660 |
| 29306 | CDC A1402 [P. Baumann 328] | 33 | 660 |
| 43382 | VVL1 | 33 | 660 |
| 29307 | CDC A8694 | 33 | 660 |
| CCUG 38297 | N/Ab | 55 | 1,110 |
| Vibrio cholerae | BEI NR-147 | N16961, O:1 | 99 | 1,980 |
| BEI NR-148 | CVD 101, O:1 | 99 | 1,980 |
| BEI NR-149 | Nanking 32/123, O:2 | 99 | 1,980 |
| BEI NR-152 | Nanking 32/124 (NCTC 8042), O:7 | 99 | 1,980 |
| 14033 | NCTC 8457 [R. Hugh 1092], O1, Inaba | 99 | 1,980 |
| 9459 | AMC 20-A-10 [R. Hugh 583], Inaba | 99 | 1,980 |
| CCUG 2573 | NAG/NCV | 99 | 1,980 |
| CCUG 2569 | NAG/NCV | 99 | 1,980 |
| CCUG 4070 | Non O-1 | 99 | 1,980 |
| CCUG 21589 | 18 | 99 | 1,980 |
| CCUG 56875 | N/A | 99 | 1,980 |
| CCUG 53725 | O1/O139 | 99 | 1,980 |
| CCUG14542 | NA | 99 | 1,980 |
| 9458 | AMC 20-A-41 [R. Hugh 582], Ogawa | 99 | 1,980 |
| 25870 | 569B | 99 | 1,980 |
| STEC O157: H7 | 43890 | CDC C984 [CDC 3526-87], H7 | 159 | 3,180 |

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| Organism | ATCC# or Source | Strain/ serovar/ serotype/ antigenic properties | Test Concentration (3xLoD) (CFU/mL) | |
| --- | --- | --- | --- | --- |
| | | | Optima Multitest Tube | Preserved Stool |
| | 43895 | CDC EDL 933, H7 | 159 | 3,180 |
| | 43894 | CDC EDL 932, H7 | 159 | 3,180 |
| | 700927 | EDL 933, H7:K- | 159 | 3,180 |
| STEC O157: NM | 700375 | CDC 94-G7771, NM | 1,197 | 23,940 |
| | 700377 | CDC 92-3099, NM | 1,197 | 23,940 |
| | 700378 | CDC 92-3073, NM | 1,197 | 23,940 |
| | AR Bank # 427a | N/A | 1,197 | 23,940 |
| | AR Bank # 428a | N/A | 1,197 | 23,940 |
| | AR Bank # 429a | N/A | 1,197 | 23,940 |
| | AR Bank # 430a | N/A | 1,197 | 23,940 |
| Plesiomonas shigelloides | 14030 | CDC 16408 [Ferguson and Henderson C27, RH 864], O:17 | 195 | 3,900 |
| | 51903 | GNI 14c | 195 | 3,900 |
| | 51572 | CIP 69.35 [2886] | 195 | 3,900 |
| | CCUG 7041A | O17: H2 | 195 | 3,900 |
| | CCUG 9221 | O17 | 195 | 3,900 |
| | CCUG 14309 | O17: H2 | 195 | 3,900 |
| | CCUG 14597 | N/A | 195 | 3,900 |

CFU = colony forming units.
a These strains were evaluated using the higher LoD of the 2 serotypes which is the NM serotype.
b For this strain 100% positivity was observed at ~5X LoD. In silico analysis showed 100% homology to amplification region.
c Strains used to establish LoD.

The inclusivity/reactivity of the Panther Fusion GI Expanded Bacterial Assay was also evaluated in silico for each intended analyte. In silico analysis was performed using analyte sequences available in the NCBI database and the whole genome shotgun sequence database. For each analyte, corresponding oligonucleotide sequences (primers and probes) were evaluated against the database sequences. Any sequences with insufficient lengths (not covering the entire amplicon region) were excluded from the analysis.

Based on in silico analysis of all sequences available up to May 30, 2023, in the databases, the Panther Fusion GI Expanded Bacterial Assay is predicted to detect 99.9% of 1,054 Yersinia Enterocolitica, 99.5% of 1,337 Vibrio parahaemolyticus, 99.1% of 1,180 Vibrio vulnificus, 98.0% of 1,189 Vibrio cholerae, 100% of 2,004 STEC O157, and 91.5% of 47 Plesiomonas shigelloides sequences evaluated.

## Competitive interference

Competitive interference in the Panther Fusion GI Expanded Bacterial Assay was evaluated in triplicate using pairs of assay analytes at low/high concentrations in negative CBS matrix. The low concentration analyte was tested at 3xLoD against a high concentration analyte at

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$10^{6}$ CFU/mL. Additionally, analytes were also tested in the absence of a second analyte. If less than $100\%$ positivity was observed for the low concentration analyte, the high concentration analyte was diluted until a concentration was reached where $100\%$ positivity was achieved for the low concentration analyte. This was observed when high concentrations of Vibrio $(10^{6}$ and $10^{5}$ CFU/mL) and low concentrations for Yersinia or STEC O157 were present. The highest concentration of competing analyte at which the low concentration analyte maintained a $100\%$ positivity is shown in Table 8. When the analytes were tested at high concentration, all results for other analytes maintained expected positivity.

Table 8. Summary of Competitive Interference study results.

| Analyte 1 | | Analyte 2 | | Yersinia % Pos | Vibrio % Pos | STEC O157 % Pos | Plesiomonas % Pos |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Name | 3xLOD (CFU/mL)a | Name | High Conc (CFUmL) | | | | |
| Negative | NA | Negative | NA | 0% | 0% | 0% | 0% |
| Yersinia | 282 | None | 0 | 100% | 0% | 0% | 0% |
| | | Vibrio | 1.0E+6 | 0% | 100% | 0% | 0% |
| | | Vibrio | 1.0E+5 | 66% | 100% | 0% | 0% |
| | | Vibrio | 1.0E+4 | 100% | 100% | 0% | 0% |
| | | Vibrio | 1.0E+3 | 100% | 100% | 0% | 0% |
| | | STEC O157 | 1.0E+6 | 100% | 0% | 100% | 0% |
| | | Plesiomonas | 1.0E+6 | 100% | 0% | 0% | 100% |
| Vibrio | 270 | None | 0 | 0% | 100% | 0% | 0% |
| | | Yersinia | 1.0E+6 | 100% | 100% | 0% | 0% |
| | | STEC O157 | 1.0E+6 | 0% | 100% | 100% | 0% |
| | | Plesiomonas | 1.0E+6 | 0% | 100% | 0% | 100% |
| STEC O157 | 1197 | None | 0 | 0% | 0% | 100% | 0% |
| | | Yersinia | 1.0E+6 | 100% | 0% | 100% | 0% |
| | | Vibrio | 1.0E+6 | 0% | 100% | 0% | 0% |
| | | Vibrio | 1.0E+5 | 0% | 100% | 33% | 0% |
| | | Vibrio | 1.0E+4 | 0% | 100% | 100% | 0% |
| | | Vibrio | 1.0E+3 | 0% | 100% | 100% | 0% |
| | | Plesiomonas | 1.0E+6 | 0% | 0% | 100% | 100% |
| Plesiomonas | 195 | None | 0 | 0% | 0% | 0% | 100% |
| | | Yersinia | 1.0E+6 | 100% | 0% | 0% | 100% |
| | | Vibrio | 1.0E+6 | 0% | 100% | 0% | 100% |
| | | STEC O157 | 1.0E+6 | 0% | 0% | 100% | 100% |
| None | 0 | Yersinia | 1.0E+6 | 100% | 0% | 0% | 0% |
| | | Vibrio | 1.0E+6 | 0% | 100% | 0% | 0% |
| | | STEC O157 | 1.0E+6 | 0% | 0% | 100% | 0% |
| | | Plesiomonas | 1.0E+6 | 0% | 0% | 0% | 100% |

$\mathrm{CFU} =$ colony forming units, $\mathrm{Pos} =$ positive.
a Analyte concentration in Aptima Multitest tube.

## Interference

Potential inhibitory effects of endogenous and exogenous substances that may be present in a specimen were evaluated in the Panther Fusion GI Expanded Bacterial Assay. Clinically relevant concentrations of potentially interfering substances were added to negative CBS matrix and tested in the absence and in the presence of GI Expanded Bacterial Assay analytes at 3x LoD. Tests were performed in triplicate. The substances and test concentrations are shown in Table 9 below. Interference was observed with Mucin at concentrations higher than

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0.1% (w:v), generating false negative results for Vibrio, Yersinia and Plesiomonas. ParaPak 10% Buffered Formalin showed interference in the detection of Vibrio and Yersinia, and ParaPak LV-PVA also showed interference for all analytes detected with the device.

Table 9. Summary of Interference study results.

| Pool # | Substance Type | Generic Name | % Positivity: Negative Panels | % Positivity: Positive Panels |
| --- | --- | --- | --- | --- |
| Neg Control | NA | Negative CBS matrix | 0.0% | NA |
| Pos Control A | | Yersinia and V.prahaemolyticus in CBS Matrix | NA | 100% |
| Pos Control B | NA | STEC O157 and P.shigelloides in CBS Matrix | NA | 100% |
| 1 | Antibiotics | Amoxicillin | 0.0% | 100% |
| | | Ampicillin | | |
| | | Doxycycline | | |
| | | Metronidazole | | |
| 2 | | Neosporin | | |
| | Anti-microbial and anti- fungal | BZK Antiseptic Towelettes | 0.0% | 100% |
| | | Nystatin | | |
| 3 | Laxatives and Stool Softeners | Dulcolax suppository | 0.0% | 100% |
| | | Colace | | |
| | | Fleet mineral oil enema | | |
| | | Ex-Lax | | |
| 4 | | Miralax | 0.0% | 100% |
| | | Milk of Magnesia | | |
| | | Visicol | | |
| 5 | Anti-diarrheal | Imodium | 0.0% | 100% |
| 6 | Anti-Itch | Vagisil | 0.0% | 100% |
| | | Preparation H | | |
| 7 | Anti- Inflammatory | Phenylephrine hydrochloride (for hemorrhoids) | 0.0% | 100% |
| | | Mesalazine (Rx only, for Crohns disease/ ulcerative colitis) | | |
| | | Aleve | | |
| 8 | Antacid | Pepto-Bismol | 0.0% | 100% |
| | | Tums | | |
| 9 | Radiopaque contrast material | Barium Sulfate | 0.0% | 100% |
| 10 | Lubricants and Skin Protectants | K-Y®Personal Lubricant Jelly Glycerin | 0.0% | 100% |
| | | Vaseline Original 100% Pure Petroleum Jelly White | | |
| | | Desitin | | |
| 11 | Spermicide | Options Conceptrol®Vaginal Contraceptive Gel | 0.0% | 100% |
| 12 | Endogenous | Cholesterol | 0.0% | 100% |
| | | Fatty acids | | |
| | | Fatty acids | | |
| | | Triglycerides, total (Fecal fat, Intralipid) | | |
| 13 | | Human Bile | 0.0% | 100% |
| | | Urine | | |
| 14 | | Human Whole Blood | 0.0% | 100% |
| 15 | | Mucin (1.3% w/v) | 0.0% (66% IC valid) | 33% Yersinia, STEC O157, and 0% Vibrio and Plesiomonas |

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| Pool # | Substance Type | Generic Name | % Positivity: Negative Panels | % Positivity: Positive Panels |
| --- | --- | --- | --- | --- |
| 15a | | Mucin (1% w/v) | 0.0% | 0% Yersinia, Vibrio, 33% Plesiomonas and 67% STEC O157 |
| 15b | | Mucin (0.5% w/v) | 0.0% | 0% Yersinia, Vibrio, 33% Plesiomonas and 67% STEC O157 |
| 15c | | Mucin (0.1% w/v) | 0.0% | 100% |
| 15d | | Mucin (0.05% w/v) | 0.0% | 100% |
| 16 | Fixation Buffer | Fisher 10% Buffered Formalin | 0.0% | 100% |
| 17 | | Parapak 10% Buffered Formalin | 0.0% | 0% Yersinia and Vibrio |
| 18 | | ParaPak LV-PVA | 0.0% (0% IC valid) | 0% |
| 19 | Solvent Control | Ethanol | 0.0% | 100% |
| 20 | | Cary- Blair Media | 0.0% | 100% |

5. Assay Reportable Range:
Not applicable.

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

Sample stability in Cary-Blair transport medium.

The stability of Panther Fusion GI Expanded Bacterial assay analytes was determined when specimens are stored as Cary-Blair preserved stool (CBS) under various storage durations and conditions, prior to transfer to an Aptima Multitest tube for testing. Stability testing panels were prepared by spiking bacterial cells into 10 unique negative stools from individual donors. GI Expanded Bacterial Assay analytes were tested in single analyte format at 3x, 10x and/or 20x LoD concentrations. Aliquots of the spiked CBS samples were tested at baseline (immediately after preparation) and then stored at 4°C, 15°C, and 30°C. Stored aliquots are tested after 72 hours or 96 hours. A total of 2 replicates/stool were tested per analyte, concentration, and storage temperature condition. A negative condition (no target spike) was also tested using 14 unique negative stools (2 replicates/stool) at baseline and after 96 hours. Specimen stability for each analyte was determined as the longest stability duration at which ≥ 90% positivity was maintained. The study results support the following storage recommendations in Cary-Blair medium:

- 2° to 8°C for up to 96 hours.
- 15° to 30°C for up to 72 hours.

Sample stability in Multitest tubes (containing Sample Transport Medium)

The stability of Panther Fusion GI Expanded Bacterial assay analytes after transferring to the Aptima Multitest tube (processed) was established when stored under various storage durations and conditions. To assess processed specimen stability, samples were first subjected to primary specimen stability in Cary-Blair summarized in the above section, and then processed into the Aptima Multitest tubes. Once in the Aptima lysis tube, samples were stored at 30°C for ≥ 7 days (for 6 days stability), at 4°C for ≥ 31 days (for 30 days stability), and at -20°C for ≥ 91 days (for 90 days stability). To assess processed stability storage at room temperature (15 – 30°C) testing was only performed at 30°C to evaluate the worst-case scenario. A total 2 replicates/stool were tested per analyte, concentration, and storage temperature condition. A negative condition (no target spike) was also tested using 14 unique

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negative stools (2 replicates/stool) at baseline and after 96 hours. The study results support the following storage conditions after collection:

- CB samples stored at 2 – 8°C for up to 96 hours or at 15 – 30°C for up to 72 hours can be transferred to the Aptima tubes and stored at:
- 15-30°C for up to 6 days,
- 2-8°C for up to 30 days, or
- -20°C for up to 90 days

## Fresh versus Frozen stability of Cary-Blair preserved stools (CBS)

The impact of freezing and multiple freeze/thaw (F/T) cycles on the stability of CBS specimens positive for GI Expanded Bacterial assay analytes relative to corresponding fresh specimens was performed. For this study 10 unique CBS pools were used to prepare the negative and contrived positive panels. Contrived positive panels were spiked with one GI Expanded Bacterial analyte at final concentrations of approximately 5xLoD, 2xLoD, and 0.99xLoD. Up to two freeze/thaw cycles were tested. This study demonstrated that freezing and thawing up to 2 cycles at the concentrations tested does not negatively impact the detection of *Plesiomonas shigelloides* and STEC O157 positivity. However, *Yersinia enterocolitica* and *Vibrio* positivity decreased after 1 F/T cycle. Therefore, it is not recommended to freeze stool samples in Cary Blair prior to testing with the Panther Fusion GI Expanded Bacterial Assay.

## 7. Detection Limit:

The Limit of Detection (LoD) of the Panther Fusion GI Expanded Bacterial Assay was determined by testing dilutions of negative CBS matrix spiked with bacterial cultures of *Yersinia enterocolitica* (2 strains), *Vibrio* (3 strains, one strain per organism detected), *Plesiomonas shigelloides* (2 strains), and STEC O157 (2 strains). A minimum of 24 replicates were tested with each of 3 reagent lots. The LoD for each analyte was determined by Probit analysis for each reagent lot and was confirmed with an additional 24 replicates using a single reagent lot in single analyte and multi- analyte configuration. LoD is defined as the lowest concentration at which ≥95% of all replicates tested positive, as summarized in Table 10 below.

Table 10. Limit of detection (LoD) for each analyte detected by the Panther Fusion GI Expanded Bacterial Assay.

| Strains | LoD Concentration (CFU/mL)a | |
| --- | --- | --- |
| | Aptima Multitest Tube | Preserved Stool |
| Yersinia enterocolitica, 33114 | 91 | 1,820 |
| Yersinia enterocolitica, 1375, O:8 | 94 | 1,880 |
| Vibrio parahaemolyticus, EB101 | 90 | 1,800 |
| Vibrio vulnificus, B9629 | 10 | 200 |
| Vibrio cholerae, 8021 | 33 | 660 |
| STEC O157:H7, EDL 931 | 53 | 1,060 |
| O157:NM, CDC 92-3073 | 357 | 7,140 |
| Plesiomonas shigelloides, CDC 3085-55 | 65 | 1,300 |
| Plesiomonas shigelloides, GNI 14 | 34 | 680 |

CFU = colony forming units.
a Analyte concentrations in Aptima Multitest tube are ~20X dilute compared to preserved stool (~150μL preserved stool in ~3 mL.

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8. Assay Cut-Off:
Not Applicable

9. Accuracy (Instrument):
Not applicable

10. Carry-Over:
Panther Fusion GI Bacterial Assay and GI Expanded Bacterial Assay belong to the same family of assays, and both utilize Cary Blair Stool as the sample type and follow identical assay processing steps. Carryover contamination was evaluated using Panther Fusion GI Bacterial Assay as a representative assay and demonstrated a 0% carryover rate. Please refer to K251868.

B Comparison Studies:

1. Method Comparison with Predicate Device:
Not applicable.

2. Transport Media Equivalency:
Equivalency between the Cary Blair (CB) transport media from different vendors for use with the Panther Fusion GI Expanded Bacterial assay was conducted using 7 unique CB transport medium. GI Expanded Bacterial Assay analytes were tested in each of the CB medium at approximately 3x LoD. Positive target panels were prepared in a multi-analyte format containing 2 analytes:

- Positive CB Panel 1: contains Yersinia enterocolitica and Vibrio group.
- Positive CB panel 2: contains STEC O157 and Plesiomonas shigelloides.

For each transport medium under evaluation, positive (with GI Expanded Bacterial analytes) and negative (no analytes) panels were tested at a minimum of 20 replicates. Testing was performed with one lot of Panther Fusion GI Expanded Bacterial Assay reagents and one Panther Fusion instrument. Overall, a ≥ 95% positivity for all analytes was observed for all CB media tested, demonstrating equivalency when tested with the Panther Fusion GI Expanded Bacterial assay.

Table 11. Summary of Transport Media Equivalency Study results.

| Panel type | Transport Media | % Positivity: Negative Panels | % Positivity: Positive Panels |
| --- | --- | --- | --- |
| Negative CB Panel | Cardinal Health C&S | 0.0% | NA |
| | ETM | 0.0% | |
| | MCC C&S | 0.0% | |
| | Para-Pak Enteric Plus | 0.0% | |
| | Para-Pak C&S | 0.0% | |
| | Protocol CB Medium | 0.0% | |
| | Remel CB w/ Indicator | 0.0% | |
| Positive CB Panel 1 | Cardinal Health C&S | NA | 100% |
| | ETM | | 100% |
| | MCC C&S | | ≥95% |
| | Para-Pak Enteric Plus | | 100% |

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| | Para-Pak C&S | 100% |
| --- | --- | --- |
| | Protocol CB Medium | ≥95% |
| | Remel CB w/ Indicator | 100% |
| Positive CB Panel 2 | Cardinal Health C&S | 100% |
| | ETM | ≥95% |
| | MCC C&S | 100% |
| | Para-Pak Enteric Plus | 100% |
| | Para-Pak C&S | ≥95% |
| | Protocol CB Medium | 100% |
| | Remel CB w/ Indicator | ≥95% |

# C Clinical Studies:

1. Clinical Sensitivity: Not applicable.
2. Clinical Specificity: Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

A multicenter study was conducted using remnant stool specimens in Cary-Blair preservative medium collected as part of routine patient care at 10 US clinics. Samples were collected from pediatric or adult patients suspected of acute gastroenteritis. All specimens were tested with the Panther Fusion GI Expanded Bacterial Assay and with comparator assays: a PCR plus bidirectional sequencing (run in duplicate) for STEC O157 and an FDA-cleared Nucleic Acid Amplification Test (NAAT) for all other targets. An alternate FDA-cleared NAAT was used for discordant analysis, if applicable. Positive (PPA) and negative (NPA) percent agreement, with corresponding two-sided 95% Confidence Intervals (CI) were calculated relative to comparator results, by target and by specimen category.

A total of 1,548 prospective specimens and 251 retrospective archived specimens were enrolled in the study; 94 specimens were excluded from the performance analyses (e.g., duplicate individuals or invalid Panther Fusion or comparator results for all targets). An additional 189 contrived specimens were tested to supplement the prospective and retrospective data for all targets. Of the 1,919 specimens tested in valid Panther Fusion GI Expanded Bacterial Assay runs, 36 (1.9%) had initial invalid results. Upon retest, 25 of the 36 specimens yielded valid results, for a total of 11 (0.6%) specimens with final invalid results. The final data set consisted of 1,894 evaluable specimens (1,523 prospective samples, 182 retrospective samples, and 189 contrived samples). Demographic information for the 1,705 evaluable prospective and retrospective archived specimens is provided in Table 12.

Table 12. Summary of Study Subject Demographics.

| | | Total N (%) | Prospective N (%) | Retrospective N (%) |
| --- | --- | --- | --- | --- |
| | Total Specimens | 1,705 | 1,523 | 182 |
| Sex | Female | 888 (52.1) | 793 (52.1) | 95 (52.2) |
| | Male | 817 (47.9) | 730 (47.9) | 87 (47.8) |
| Age Group | 0 to 28 days | 7 (0.4) | 7 (0.5) | 0 (0) |
| | 29 days to <2 years | 74 (4.3) | 67 (4.4) | 7 (3.8) |
| | 2 to 5 years | 55 (3.2) | 50 (3.3) | 5 (2.7) |

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Performance characteristics for Yersinia enterocolitica, Vibrio (V. cholerae, V. parahaemoliticus, and V. vulnificus), STEC O157, and Plesiomonas shigelloides are presented by study cohort in tables below. No coinfections were detected by the Panther Fusion GI Expanded Bacterial Assay or by the comparator methods in prospective of retrospectively collected specimens.

Table 13. Summary of Clinical Performance – Yersinia enterocolitica

| | PROSPECTIVE | | RETROSPECTIVE | | CONTRIVED | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Comparator | | Comparator | | Comparator | |
| | | Positive | Negative | Positive | Negative | Positive | Negative |
| Panther Fusion GI Expanded Bacterial Test | Positive | 10 | 9^{a} | 15 | 3^{c} | 63 | 0 |
| | Negative | 1^{b} | 1487 | 0 | 164 | 0 | 126 |
| | Total | 11 | 1496 | 15 | 167 | 63 | 126 |
| | PPA (95%CI) | 90.9% (62.3% - 98.4%) | | 100% (79.6% - 100%) | | 100% (94.2% - 100%) | |
| | NPA (95%CI) | 99.4% (98.9% - 99.7%) | | 98.2% (94.8% - 99.4%) | | 100% (97.0% - 100%) | |

a 6 of 9 discordant false positive prospective specimens were positive for Yersinia by the alternate NAAT.
b The discordant false negative prospective specimen was negative for Yersinia by the alternate NAAT.
c The 3 discordant false positive retrospective specimens were positive for Yersinia by the alternate NAAT.

Table 14. Summary of Clinical Performance – Vibrio spp.

| | PROSPECTIVE | | RETROSPECTIVE | | CONTRIVED | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Comparator | | Comparator | | Comparator | |
| | | Positive | Negative | Positive | Negative | Positive | Negative |
| Panther Fusion GI Expanded Bacterial Test | Positive | 1 | 0 | 9 | 6^{b} | 63 | 1^{c} |
| | Negative | 1^{a} | 1505 | 0 | 167 | 0 | 125 |
| | Total | 2 | 1505 | 9 | 173 | 63 | 126 |
| | PPA (95%CI) | 50.0% (9.5% - 90.5%) | | 100% (70.1% - 100%) | | 100% (94.3% - 100%) | |
| | NPA (95%CI) | 100% (99.7% - 100%) | | 96.5% (92.6% - 98.4%) | | 99.2% (95.6% - 99.9%) | |

a The discordant false negative prospective specimen was positive for Vibrio by the alternate NAAT.
b All 6 discordant false positive retrospective specimens were positive for Vibrio by the alternate NAAT.
c The discordant false positive contrived specimen was negative for Vibrio by the alternate NAAT.

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Table 15. Summary of Clinical Performance – STEC O157

| | PROSPECTIVE | | RETROSPECTIVE | | CONTRIVED | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Comparator | | Comparator | | Comparator | |
| | | Positive | Negative | Positive | Negative | Positive | Negative |
| Panther Fusion GI Expanded Bacterial Test | Positive | 1 | 2^{a} | 3 | 1^{b} | 62 | 1^{c} |
| | Negative | 0 | 1519 | 0 | 178 | 1^{d} | 125 |
| | Total | 1 | 1521 | 3 | 179 | 63 | 126 |
| | PPA (95%CI) | 100% (20.7% - 100%) | | 100% (43.9% - 100%) | | 98.4% (91.54% - 99.7%) | |
| | NPA (95%CI) | 99.9% (99.5% - 100%) | | 99.4% (96.9% - 99.9%) | | 99.2% (95.6% - 99.9%) | |

a 1 of 2 discordant false positive prospective specimens was negative for STEC O157 by the alternate NAAT. The other discordant was positive for O157 but negative for stx1/stx2 by the alternate NAAT.
b The discordant false positive retrospective specimen was positive for STEC O157 by the alternate NAAT.
c The discordant false positive contrived specimen was negative for STEC O157 by the alternate NAAT
d The discordant false negative contrived specimen was not retested by the alternate NAAT

Table 16. Summary of Clinical Performance – Plesiomonas shigelloides

| | PROSPECTIVE | | RETROSPECTIVE | | CONTRIVED | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Comparator | | Comparator | | Comparator | |
| | | Positive | Negative | Positive | Negative | Positive | Negative |
| Panther Fusion GI Expanded Bacterial Test | Positive | 1 | 1^{a} | 8 | 1^{b} | 62 | 0 |
| | Negative | 0 | 1505 | 0 | 173 | 1^{c} | 126 |
| | Total | 1 | 1506 | 8 | 174 | 63 | 126 |
| | PPA (95%CI) | 100% (20.7% - 100%) | | 100% (67.6% - 100%) | | 98.4% (91.5% - 99.7%) | |
| | NPA (95%CI) | 99.9% (99.6% - 99.9%) | | 99.4% (96.8% - 99.9%) | | 100% (97.0% - 100%) | |

a The discordant false positive prospective specimen was positive for Plesiomonas by the alternate NAAT.
b The discordant false positive retrospective specimen was positive for Plesiomonas by the alternate NAAT.
c The discordant false negative contrived specimen was not retested by the alternate NAAT.

D Clinical Cut-Off:
Not applicable

E Expected Values/Reference Range:
In the Panther Fusion GI Expanded Bacterial Assay clinical study, reportable results from evaluable specimens were obtained from four geographically diverse sites and compared to the comparator method. The number and percentage of positive cases by target and site as determined by the Panther Fusion GI Expanded Bacterial Assay during the prospective segment of the clinical study are presented in table 17 below.

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Table 17. Prevalence Values Observed during the Clinical Study

| % Positivity (# positive/# evaluable) | | | | |
| --- | --- | --- | --- | --- |
| Collection site | Yersinia | Vibrio | O157 | Plesiomonas |
| Total evaluable for target, N | 1507 | 1507 | 1522 | 1507 |
| All Sites | 1.3 (19/1507) | 0.1 (1/1507) | 0.2 (3/1522) | 0.1 (2/1507) |
| Site 1 | 2.3 (10/441) | 0 (0/441) | 0.2 (1/447) | 0 (0/441) |
| Site 2 | 1.0 (5/489) | 0.2 (1/489) | 0.2 (1/498) | 0 (0/489) |
| Site 3 | 0.8 (4/482) | 0 (0/482) | 0.2 (1/482) | 0.2 (1/482) |
| Site 4 | 0 (0/95) | 0 (0/95) | 0 (0/95) | 1.1 (1/95) |

F Other Supportive Instrument Performance Characteristics Data:
Not applicable

VIII Proposed Labeling:
The labeling supports or the finding of substantial equivalence for this device.

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

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