NeuMoDx CT/NG Assay 2.0

K230267 · Neumodx Molecular, Inc. · QEP · Dec 22, 2023 · Microbiology

Device Facts

• Record ID: K230267
• Device Name: NeuMoDx CT/NG Assay 2.0
• Applicant: Neumodx Molecular, Inc.
• Product Code: QEP · Microbiology
• Decision Date: Dec 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3393
• Device Class: Class 2

Intended Use

The NeuMoDx CT/NG Assay 2.0, as implemented on the NeuMoDx 96 Molecular System and NeuMoDx 288 Molecular System, is an automated, qualitative test for the direct detection and differentiation of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA as an aid in the diagnosis of chlamydial and gonococcal urogenital disease in symptomatic and asymptomatic individuals. The Assay utilizes real-time Polymerase Chain Reaction (PCR) and may be used to test male and female urine, and self-collected vaginal swab specimens (collected in a clinical setting).

Device Story

Automated in vitro diagnostic test for direct detection/differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae DNA; utilizes real-time PCR and fluorogenic TaqMan probes; employs paramagnetic bead technology for nucleic acid extraction from urine and vaginal swab specimens. Implemented on NeuMoDx 96 and 288 Molecular Systems; provides complete automation from lysis to result reporting in 8 hours. Systems include XPCR modules, liquid/cartridge/plate workstation, and PC interface. Healthcare providers use results as an aid in diagnosis of urogenital disease; automated interpretation reduces manual error; enables rapid clinical decision-making for patient management.

Clinical Evidence

Prospective, multi-center study (14 sites) with 4017 participants (1825 males, 2192 females). Compared NeuMoDx CT/NG Assay 2.0 results against Patient Infected Status (PIS) established by two FDA-cleared NAATs. Results across all specimen types (SCVS, FU, MU) showed high sensitivity (92.3%-100%) and specificity (99.5%-100%) for both CT and NG. Invalid/unresolved rates were low (0.2% unresolved).

Technological Characteristics

Automated real-time PCR system. Materials: unitized reagent test strips, extraction plates with dried reagents, lysis buffer (chaotropic salts), wash/release reagents. Sensing: fluorogenic TaqMan probes. Connectivity: standalone/networked NeuMoDx 96/288 systems. Software: automated result interpretation based on Ct, EP, and EPR thresholds. Sterilization: not specified.

Indications for Use

Indicated for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in symptomatic and asymptomatic individuals. Patient population includes males and females (age 15-77). Specimens include male/female urine and self-collected vaginal swabs (collected in clinical settings).

Regulatory Classification

Identification

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) and their associated resistance markers in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist that are not detected by the device.

Special Controls

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) must comply with the following special controls: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device: alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including, but not limited to. Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate; (iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing. (iv) Limiting statements indicating that: (A)a negative test result does not preclude the possibility of infection; (B) the test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe procedures in any one of these steps can lead to incorrect results; and (D)if appropriate (e.g., recommended by CDC, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type. (v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that: (A)negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present; (B) detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora; (C) detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and (D) therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy. (4) Design verification and validation must include: (i) Detailed device description documentation, including, but not limited to, methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported result). (ii) Detailed documentation of analytical studies including but not limited to, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, with-in lab precision, and reproducibility, as appropriate. (iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses. (iv) A detailed description of the impact of any software, including, but not limited to, software applications and hardware-based devices that incorporate software, on the device's functions.

*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device. (3) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens; (ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate; (iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing; (iv) Limiting statements indicating that: (A) A negative test result does not preclude the possibility of infection; (B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician; (C) Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and (D) If appropriate ( *e.g.,* recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type; and(v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that: (A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present; (B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora; (C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and (D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy. (4) Design verification and validation must include: (i) Detailed device description documentation, including methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result ( *e.g.,* how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate. (iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses. (iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.

Predicate Devices

• Aptima Combo 2 Assay (Panther System) (k190515)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 22, 2023

NeuMoDx Molecular, Inc. % Eveline Arnold Director, Regulatory Affairs Qiagen 19300 Germantown Road Germantown, Maryland 20874

Re: K230267

Trade/Device Name: NeuMoDx CT/NG Assay 2.0 Regulation Number: 21 CFR 866.3393 Regulation Name: Device To Detect Nucleic Acids From Non-Viral Microorganism(S) Causing Sexually Transmitted Infections And Associated Resistance Marker(S) Regulatory Class: Class II Product Code: QEP Dated: January 30, 2023 Received: January 31, 2023

Dear Eveline Arnold:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Himani Bisht -

Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch

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Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k230267

Device Name NeuMoDx CT/NG Assay 2.0

#### Indications for Use (Describe)

The NeuMoDx CT/NG Assay 2.0, as implemented on the NeuMoDx 96 Molecular System and NeuMoDx 288 Molecular System, is an automated, qualitative test for the direct detection of Chlamydia trachomatis (CT) and or Neisseria gonorrhoeae (NG) DNA as an aid in the diagnosis of chlamydial and gonococcal urogenital disease in symptomatic and asymptomatic individuals. The Assay utilizes real-time Polymerase Chain Reaction (PCR) and may be used to test male and female urine, and self-collected vaginal swab specimens (collected in a clinical setting).

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 510(k) SUMMARY

#### General Information

| Submitted by: | NeuMoDx Molecular, Inc.<br>1250 Eisenhower Place<br>Ann Arbor, MI 48108<br>USA |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eveline Arnold, PhD.<br>Director, Regulatory Affairs<br>NeuMoDx Molecular, Inc.<br>19300 Germantown Rd<br>Germantown, MD 20874 |
| | Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 21, 2023 |
| Device Name: | NeuMoDx™ CT/NG Assay 2.0 |
| Trade Name: | NeuMoDx™ CT/NG Assay 2.0 |
| Common Name: | NeuMoDx CT/NG Assay 2.0 |

Classification Name: Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections(21 C.F.R. §866.3393),

| Product code: | QEP |
|---------------|-----|
|---------------|-----|

Predicate Device

| Manufacturer | Product Name | 510(k) No. |
|---------------|------------------------------------------|------------|
| Hologic, Inc. | Aptima Combo 2 Assay<br>(Panther System) | k190515 |

## Device Description

The NeuMoDx CT/NG Assay 2.0 is an automated in vitro diagnostic test for the direct detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) DNA from asymptomatic and symptomatic patient specimens. The assay utilizes real-time polymerase chain reaction (PCR) for the amplification of CT and/or NG DNA and fluorogenic targetspecific TaqMan probes for the detection of the amplified DNA. At the end of the test, a determination of the presence/absence of CT and/or NG DNA in the specimen is automatically made based on the amplification status of the CT and/or NG DNA and/or Sample Process Control sequences using pre-established decision criteria. The NeuMoDx CT/NG Assay 2.0 is intended as an aid to diagnose CT and NG infections in symptomatic.

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or asymptomatic individuals, but not to guide or monitor treatment for CT and NG infections. Concomitant cultures may be necessary to recover organisms for epidemiological typing or for further susceptibility testing.

# Intended Use

The NeuMoDx CT/NG Assay 2.0, as implemented on the NeuMoDx 96 Molecular System and NeuMoDx 288 Molecular System, is an automated, qualitative test for the direct detection and differentiation of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA as an aid in the diagnosis of chlamydial and gonococcal urogenital disease in symptomatic and asymptomatic individuals. The Assay utilizes real-time Polymerase Chain Reaction (PCR) and may be used to test male and female urine, and self-collected vaginal swab specimens (collected in a clinical setting).

## Special Conditions For Use Statements

For prescription use only. For in vitro diagnostic use.

# Ancillarv Reagents

The NeuMoDx System consists of assay specific test strip, consumables, reagents, accessories, and software. The following sections describe the system components.

# Assay-specific components consist of the following (included with the NeuMoDx CT/NG Assav 2.0):

## NeuMoDx CT/NG Test Strip 2.0 IREF 2003011

The NeuMoDx CT/NG Test Strip 2.0 is a consumable, real-time PCR reagent compatible with the NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System (NeuMoDx System(s)) used to implement the NeuMoDx CT/NG Assay 2.0.

The NeuMoDx CT/NG Test Strip 2.0 contains ambient condition stable PCR reagents at the bottom of each well (unitized reagent format). The reagents enable amplification and detection of the desired CT/NG specific targets as well as the sample process control (SPC1). It is the main component of the assay and can only be used in conjunction with the other NeuMoDx CT/NG Assay 2.0 components.

# The main ancillary Consumables and Reagents that are required to perform are listed below (not included with the NeuMoDx CT/NG Assay 2.0):

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# NeuMoDx Extraction Plate [REF 100200]

The NeuMoDx Extraction Plate is a custom 24-well plate with ambient condition stable, dried reagents at the bottom of each well. The reagents are effective for cell lysis, protein degradation, nucleic acid binding, and process monitoring. The extraction plate is a universal consumable for all specimen types and nucleic acid targets validated for use with the system.

# NeuMoDx Cartridge [REF 100100]

The NeuMoDx Cartridge incorporates a proprietary microfluidic design and allows for independent nucleic acid extraction and purification, as well as PCR amplification and detection in individual lanes for up to 12 samples when used in the NeuMoDx Systems.

# NeuMoDx Lysis Buffer 2 [REF 400500]

NeuMoDx Lysis Buffer is a custom pre-filled container sealed with a pierceable septum and removable top foil. It contains a proprietary formulation of salts and chaotropic agents to provide efficient lysis of bacterial targets in human urogenital specimens. The trough itself is a flat-bottomed, free-standing, reservoir contains at least 80 mL of usable buffer.

# NeuMoDx Wash Reagent [REF 400100]

The NeuMoDx Wash Reagent is supplied in a flat-bottomed, free-standing 2L bottle. It is supplied separately to the customer.

# NeuMoDx Release Reagent [REF 400200]

The NeuMoDx Release Reagent is supplied in a plastic-lined, aluminum pouch inside a flat-bottomed, freestanding box. It is supplied separately to the customer.

# Comparison of the NeuMoDx CT/NG Assay 2.0 and the Predicate Device

The NeuMoDx CT/NG Assay 2.0 is substantially equivalent to the predicate device:

- . k190515: Aptima Combo 2 Assay (Panther System)
Similarities and differences between NeuMoDx CT/NG Assay 2.0 and the predicate device are shown in Table 1.

| Characteristic | Device | Predicate |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | NeuMoDx CT/NG Assay<br>2.0 on the NeuMoDx 288<br>and 96 Molecular System | Aptima Combo 2 Assay<br>(Panther) |
| 510(k) No. | k230267 | k190515 |
| Regulatory Number | 21 CFR 866.3390 | 21 CFR 866.3390 |
| Product Code | QEP | QEP |
| Device Class | II | II |
| Characteristic | Device | Predicate |
| Similarities | | |
| Intended Use | The NeuMoDx CT/NG<br>Assay 2.0, as implemented<br>on the NeuMoDx 96<br>Molecular System and<br>NeuMoDx 288 Molecular<br>System, is an automated,<br>qualitative test for the direct<br>detection and differentiation<br>of Chlamydia trachomatis<br>(CT) and/or Neisseria<br>gonorrhoeae (NG) DNA as<br>an aid in the diagnosis of<br>chlamydial and gonococcal<br>urogenital disease in<br>symptomatic and<br>asymptomatic individuals.<br>The Assay utilizes real-time<br>Polymerase Chain Reaction<br>(PCR) and may be used to<br>test male and female urine,<br>and self-collected vaginal<br>swab specimens (collected in<br>a clinical setting). | The Aptima Combo 2 Assay is<br>a target amplification nucleic<br>acid probe test that utilizes<br>target capture for the in vitro<br>qualitative detection and<br>differentiation of ribosomal<br>RNA (rRNA) from Chlamydia<br>trachomatis (CT) and/or<br>Neisseria gonorrhoeae (GC) to<br>aid in the diagnosis of<br>chlamydial and/or gonococcal<br>disease using the Panther<br>System as specified. On the<br>Panther System, the assay may<br>be used to test the following<br>specimens from symptomatic<br>and asymptomatic individuals:<br>clinician-collected<br>endocervical, vaginal, throat,<br>rectal and male urethral swab<br>specimens, clinician-collected<br>gynecological specimens<br>collected in the PreservCyt<br>Solution, patient-collected<br>vaginal swab specimens, and<br>female and male urine<br>specimens.<br>Patient-collected vaginal swab<br>specimens are an option for<br>screening women when a<br>pelvic exam is not otherwise<br>indicated. The Aptima<br>Multitest Swab Specimen<br>Collection Kit has not been<br>evaluated for home use. |
| Specimen Type | <b>Female specimens:</b><br>Self-collected vaginal swab (collected in a clinical setting) | <b>Female specimens:</b><br>Vaginal swabEndocervical swabGynecological specimens in PreservCyt solutionUrine |
| Characteristic | Device | Predicate |
| | Urine Male Specimens: Urine | Throat swab Rectal swab Male Specimens: Urethral swab Urine Throat swab Rectal swab |
| Assay Targets | Chlamydia trachomatis (CT) cryptic plasmid DNA<br>CT OMP gene<br>Neisseria gonorrhoeae (NG) opacity (OPC) gene | Chlamydia trachomatis (CT) and/or<br>Neisseria gonorrhoeae (GC) rRNA |
| Nucleic Acid Extraction | Extraction of nucleic acids using paramagnetic particles | Extraction of nucleic acids using Magnetic microparticles |
| Assay Controls | N/A | N/A |
| Differences | | |
| Amplification and<br>Detection Technology | Real-time PCR, TaqMan Chemistry | Target Capture (TC), Transcription-Mediated Amplification (TMA), Hybridization Protection Assay (HPA) |
| Amplification and<br>Detection Instrument<br>System | NeuMoDx 288 and N96 System | Panther System |

## Table 1: Comparison of the NeuMoDx CT/NG Assay 2.0 with the predicate device

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# Performance Characteristics - Clinical Study

The clinical performance characteristics of the NeuMoDx CT/NG Assay 2.0 as implemented on the NeuMoDx 96 and 288 Molecular Systems were established in a multicenter, pivotal, prospective urogenital specimen collection study comparing the results of the NeuMoDx CT/NG Assay 2.0 on the NeuMoDx 96 and 288 Molecular Systems (collectively named the NeuMoDx CT/NG 2.0 test system) to a patient infected status (PIS) algorithm based on results from FDA-cleared, legally marketed Nucleic Acid Amplification Tests (NAATs). A summary of the study design is provided below.

# Samples Collected

A single neat urine sample was collected from each male subject. Additionally, a single self-collected vaginal swab (collected in a clinical setting) and two cliniciancollected vaginal swabs (CCVS) were also collected from each female subject. Male and female urine, as well as the self-collected vaginal swabs (SCVS) underwent testing using the NeuMoDx CT/NG Assay 2.0. Urine and the clinician-collected vaginal swab specimens were utilized for comparator method testing to establish the patient-infected status.

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# Sites and Comparator Testing

All evaluable samples were tested at three external laboratories using the NeuMoDx CT/NG Assay 2.0 following the package insert instructions for use. All comparison testing was conducted at a separate reference laboratory using FDA-cleared NAAT assays in accordance with the manufacturers' package insert instructions for female subjects, urine and clinician-collected vaginal swab specimens were tested using two FDAcleared NAATs to establish the patient infected status (PIS). The infected status for female subjects was determined by combining results from two specimen types and two comparator NAATs. The male PIS was established using urine results from two FDAcleared comparator NAATs.

# Patient Infected Status Determination

The infection status of each participant was determined using a prespecified patient infected status (PIS) algorithm. For female participants, the PIS was established from the results of female urine (FU) and clinician-collected vaginal swab (CCVS) specimens tested by two FDA-cleared NAAT comparator assays. Females were classified as infected if at least one positive result was obtained by each assay. Any other combination of results was considered a non-infected status. Male subjects were classified as infected if both comparator urine NAAT results were positive. If the male urine results were conflicting (i.e. one positive and one negative), a third FDA-cleared NAAT method was performed as a tie-breaker to adjudicate male infection status.

See Tables 2 to 3 for CT/NG Assay 2.0 results vs patient infected status algorithms.

# Subjects Enrolled and Exclusions

Specimens were collected from symptomatic and asymptomatic females and males enrolled from 14 geographically and demographically diverse U.S. sites, including family practice clinics, obstetrics/gynecology practices, public health centers, sexual transmitted disease (STD) clinics, family planning clinics, college campus and adolescent clinics, and hospital emergency departments/urgent care centers. Each subject was classified as symptomatic if the subject reported symptoms and asymptomatic if the subject did not report symptoms. The average age of all study subjects in the eligible population was 31 ± 10 years and ranged from 15 to 77.

A total of 4017 participants with a mean age of 31±10 years (median: 29; range:15-77 years) were enrolled in the study, including 1825 males and 2192 females. Among the 1825 males enrolled in the study, five participants were excluded after consent as a result of not meeting eligibility criteria (n=3), previous enrollment (n=1), or withdrawal owing to insufficient urine collection (n=1), which resulted in 1820 valid male participants. Among the 2192 females enrolled, 36 were excluded after consent, with reasons including ineligibility or unconfirmed eligibility (n=13), withdrawal from the study (n=4), and samples evaluable by the NeuMoDx CT/NG Assay 2.0 not collected (n=19), leaving 2156 females included in the study.

Of the remaining 1820 male participants, a urine specimen was collected from each, but 119 specimens were excluded from analysis owing to protocol deviation, collection or instrument device events, and other specimen testing issues which prevented a final result from being obtained by NeuMoDx CT/NG Assay 2.0 or comparator method, which left data from a total of 1701 male subjects included in the data analysis.

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Of the 1701 male urine specimens, for CT, there were 10 cases where either a valid NeuMoDx CT/NG Assay 2.0 result could not be determined (n=2) or where the PIS result could not be determined (n=8), therefore there were 1691 male urine specimens included in the primary analysis. Similarly, for NG, there were 3 cases where a valid NeuMoDx CT/NG Assay 2.0 result could not be determined, therefore there were 1698 male urine specimens included in the primary analysis.

Among the evaluable specimens collected from the 2156 female participants, 138 urine specimens and 140 self-collected vaginal swab specimens were excluded due to protocol deviations, collection device events, instrument device events, and other events which prevented a final result from being obtained by NeuMoDx CT/NG Assay 2.0 or comparator, allowing for 2018 and 2016 female subject specimens included in the study for urine and SCVS respectively.

Of the 2018 female urine specimens, there were 11 cases where a valid NeuMoDx CT/NG Assay 2.0 result could not be determined for the CT target and 12 cases where a valid result was not obtained for the NG target; therefore, there were 2007 female urine specimens included in the primary analysis for CT and 2006 for NG.

Of the 2016 self-collected vaginal swab specimens, all produced valid results for CT and NG with the NeuMoDx CT/NG Assay 2.0 and comparator test; these subjects are included in the primary data analysis.

# Chlamydia trachomatis Performance Results

The summary table of the performance data for the NeuMoDx CT/NG Assay 2.0 for CT detection is shown below in Table 2. Invalid results (IND and UNR) are not included in the sensitivity and specificity calculations shown below. Sensitivity and specificity were calculated by comparing NeuMoDx CT/NG Assay 2.0 results to the patient infected status algorithm.

| Specimen | Symptom<br>Status | n | TP | FP | TN | FN | Prev. | Sensitivity | Specificity |
|----------|-------------------|------|-----|----|------|----|-------|------------------------|------------------------|
| MU | Asymp. | 1227 | 102 | 0 | 1123 | 2 | 8.5% | 98.1% (93.3%, 99.5%) | 100.0% (99.7%, 100.0%) |
| MU | Symp. | 464 | 82 | 1 | 377 | 4 | 18.5% | 95.3% (88.6%, 98.2%) | 99.7% (98.5%, 100.0%) |
| MU | All | 1691 | 184 | 1 | 1500 | 6 | 11.2% | 96.8% (93.3%, 98.5%) | 99.9% (99.6%, 100.0%) |
| FU | Asymp. | 1054 | 40 | 1 | 1010 | 3 | 4.1% | 93.0% (81.4%, 97.6%) | 99.9% (99.4%, 100.0%) |
| FU | Symp. | 953 | 56 | 3 | 889 | 5 | 6.4% | 91.8% (82.2%, 96.4%) | 99.7% (99.0%, 99.9%) |
| FU | All | 2007 | 96 | 4 | 1899 | 8 | 5.2% | 92.3% (85.6%, 96.1%) | 99.8% (99.5%, 99.9%) |
| SCVS | Asymp. | 1052 | 43 | 2 | 1007 | 0 | 4.1% | 100.0% (91.8%, 100.0%) | 99.8% (99.3%, 99.9%) |
| SCVS | Symp. | 964 | 58 | 7 | 896 | 3 | 6.3% | 95.1% (86.5%, 98.3%) | 99.2% (98.4%, 99.6%) |
| SCVS | All | 2016 | 101 | 9 | 1903 | 3 | 5.2% | 97.1% (91.9%, 99.0%) | 99.5% (99.1%, 99.8%) |

Table 2: NeuMoDx CT/NG Assay vs Patient Infected Status for CT Detection (N96 and N288 Combined)

Neisseria Gonorrhoeae Performance Results

{11}------------------------------------------------

The summary table of the performance data for the NeuMoDx CT/NG Assay 2.0 for NG detection is shown below in Table 3. Invalid results (IND and UNR) are not included in the sensitivity and specificity calculations shown below. Sensitivity and specificity were calculated by comparing NeuMoDx CT/NG Assay 2.0 results to the patient infected status algorithm.

| | Table 3: NeuMoDx CT/NG Assay vs Patient Infected Status for NG Detection |
|-------------------------|--------------------------------------------------------------------------|
| (N96 and N288 Combined) | |

| Specimen | Symptom Status | n | TP | FP | TN | FN | Prev. | Sensitivity | Specificity |
|----------|----------------|------|----|----|------|----|-------|------------------------|------------------------|
| MU | Asymp. | 1231 | 11 | 1 | 1219 | 0 | 0.9% | 100.0% (74.1%, 100.0%) | 99.9% (99.5%, 100.0%) |
| MU | Symp. | 467 | 81 | 1 | 384 | 1 | 17.6% | 98.8% (93.4%, 99.8%) | 99.7% (98.5%, 100.0%) |
| MU | All | 1698 | 92 | 2 | 1603 | 1 | 5.5% | 98.9% (94.2%, 99.8%) | 99.9% (99.5%, 100.0%) |
| FU | Asymp. | 1053 | 22 | 0 | 1029 | 2 | 2.3% | 91.7% (74.2%, 97.7%) | 100.0% (99.6%, 100.0%) |
| FU | Symp. | 953 | 20 | 1 | 931 | 1 | 2.2% | 95.2% (77.3%, 99.2%) | 99.9% (99.4%, 100.0%) |
| FU | All | 2006 | 42 | 1 | 1960 | 3 | 2.2% | 93.3% (82.1%, 97.7%) | 99.9% (99.7%, 100.0%) |
| SCVS | Asymp. | 1052 | 24 | 0 | 1028 | 0 | 2.3% | 100.0% (86.2%, 100.0%) | 100.0% (99.6%, 100.0%) |
| SCVS | Symp. | 964 | 20 | 2 | 941 | 1 | 2.2% | 95.2% (77.3%, 99.2%) | 99.8% (99.2%, 99.9%) |
| SCVS | All | 2016 | 44 | 2 | 1969 | 1 | 2.2% | 97.8% (88.4%, 99.6%) | 99.9% (99.6%, 100.0%) |

Male Urine, FU = Female Urine, SCVS = Self-Collected Vaginal Swab

Symp. = Symptomatic. Asymp. = Asymptomatic

Prev. = Prevalence, TP = True Positive, FP = False Positive, TN = True Negative, FN = False Negative

## Chlamydia trachomatis Patient Infected Status Tables

The frequency of test outcomes from the cleared comparator NAATs and investigational NeuMoDx System testing is summarized in Tables 4 and 5 for CT.

| PIS | NAAT 1 | NAAT 2 | NAAT 3 | NeuMoDx | Count | | |
|------------------------------------------------------------------------------------------------------------|--------|--------|--------|---------|-------|--------|-------|
| Overall | Urine | Urine | Urine | Urine | Symp. | Asymp. | Total |
| NI | - | - | NA | IND | 0 | 1 | 1 |
| NI | - | - | NA | - | 377 | 1123 | 1500 |
| NI | - | - | NA | + | 1 | 0 | 1 |
| NI | - | - | NA | UNR | 0 | 1 | 1 |
| Total | | | | | 378 | 1125 | 1503 |
| I | - | + | + | - | 1 | 0 | 1 |
| I | + | + | NA | - | 3 | 2 | 5 |
| I | + | + | NA | + | 82 | 102 | 184 |
| Total | | | | | 86 | 104 | 190 |
| IND = Indeterminate, UNR = Unresolved, EQ = Equivocal<br>NI = Non-infected, I = Infected, NA=Not Available | | | | | | | |

# Table 4: Patient Infected Status - Male Urine, CT

{12}------------------------------------------------

| PIS | | NAAT 1 | | NAAT 2 | | NeuMoDx | Count | | |
|---------|------|--------|------|--------|------|---------|-------|--------|-------|
| Overall | CCVS | Urine | CCVS | Urine | scus | Urine | Symp. | Asymp. | Total |
| NI | NA | NA | - | - | - | NA | l | 0 | 1 |
| NI | - | NA | - | NA | - | - | 0 | 2 | 2 |
| NI | - | NA | - | " | - | NA | l | 0 | l |
| NI | - | NA | - | - | - | - | 5 | 3 | 8 |
| NI | - | NA | - | - | - | UNR | 4 | 0 | 4 |
| NI | NA | - | NA | - | - | - | l | 2 | 3 |
| NI | NA | - | - | - | - | - | 7 | 3 | 10 |
| NI | NA | - | + | + | + | - | l | 0 | l |
| NI | - | - | - | NA | - | - | 0 | 1 | l |
| NI | - | - | EQ | - | - | - | 0 | 1 | l |
| NI | - | - | - | - | - | NA | 5 | 0 | 5 |
| NI | - | - | - | - | | - | 6 | 4 | 10 |
| NI | - | - | - | - | - | - | 856 | 990 | 1846 |
| NI | - | - | - | - | + | - | l | 2 | 3 |
| NI | - | - | - | - | - | + | 2 | 0 | 2 |
| NI | - | - | - | - | + | + | l | 0 | 1 |
| NI | - | - | - | - | - | UNR | 5 | 2 | 7 |
| NI | - | - | + | - | - | - | 6 | 2 | 8 |
| NI | - | - | + | - | + | - | 2 | 0 | 2 |
| NI | - | - | - | + | - | - | l | 0 | 1 |
| NI | - | - | - | + | - | + | 0 | l | 1 |
| NI | - | - | + | + | + | - | l | 0 | 1 |
| NI | + | - | - | - | + | - | l | 0 | l |
| NI | NA | - | NA | - | - | - | l | 0 | 1 |
| Total | | | | | | | 908 | 1013 | 1921 |
| I | + | NA | + | + | + | NA | l | 0 | l |
| I | + | - | + | - | - | - | l | 0 | 1 |
| I | + | - | + | - | + | - | l | 1 | 2 |
| I | + | - | + | + | - | - | l | 0 | 1 |
| I | + | - | + | + | + | - | 0 | 2 | 2 |
| I | + | - | + | + | + | + | 0 | 3 | 3 |
| I | NA | + | + | + | + | + | 2 | l | 3 |
| ]* | - | + | - | + | - | + | l | 0 | 1 |
| I | - | + | - | + | + | + | l | 0 | 1 |
| I | - | + | + | + | + | + | 2 | 2 | 4 |
| I | + | + | + | EQ | + | + | l | 0 | l |
| I | + | + | + | - | + | + | l | 0 | 1 |
| I | + | + | - | + | + | + | 1 | 1 | 2 |
| I | + | + | + | + | - | - | l | 0 | 1 |

{13}------------------------------------------------

| PIS | NAAT 1 | | NAAT 2 | | NeuMoDx | | Count | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------|--------|-------|---------|-------|-------|--------|-------|--|
| Overall | CCVS | Urine | CCVS | Urine | SCVS | Urine | Symp. | Asymp. | Total | |
| I | + | + | + | + | + | - | 1 | 0 | 1 | |
| I | + | + | + | + | + | + | 46 | 33 | 79 | |
| I | + | + | NA | + | + | + | 1 | 0 | 1 | |
| Total | | | | | | | 62 | 43 | 105 | |
| SCVS = Self-Collected Vaginal Swab<br>IND = Indeterminate, UNR = Unresolved, EQ = Equivocal<br>NI = Non-infected, I = Infected, NA=Not Available | | | | | | | | | | |

*One female subject tested negative for CT in the swab specimens by both comparator NAATs and positive in urine by both comparator NAATs. For calculations of performance, the swab sample from this subject was considered a "True Negative", while the urine sample was considered a "True Positive."

#### Neisseria Gonorrhoeae Infected Status Tables

The frequency of test outcomes from the cleared comparator NAATs and investigational NeuMoDx System testing is summarized in Tables 6 and 7 for NG.

| PIS | NAAT 1 | NAAT 2 | NAAT 3 | NeuMoDx | Count | | | |
|---------|-------------------------------------------------------|--------|--------|---------|-------|--------|-------|--|
| Overall | Urine | Urine | Urine | Urine | Symp. | Asymp. | Total | |
| NI | - | - | NA | IND | 0 | 2 | 2 | |
| NI | - | - | NA | - | 384 | 1219 | 1603 | |
| NI | - | - | NA | + | 1 | 1 | 2 | |
| NI | - | - | NA | UNR | 0 | 1 | 1 | |
| Total | | | | | 385 | 1223 | 1608 | |
| I | + | + | NA | - | 1 | 0 | 1 | |
| I | + | + | NA | + | 81 | 11 | 92 | |
| Total | | | | | 82 | 11 | 93 | |
| | IND = Indeterminate, UNR = Unresolved, EQ = Equivocal | | | | | | | |

## Table 6: Patient Infected Status - Male Urine, NG

IND = Indeterminate, UNR = Unresolved, EQ = Equivocal
NI - Non infected I - Infected NA - Not Available

| NI = Non-infected, I = Infected, NA = Not Available

# Table 7: Patient Infected Status - Female NG

| PIS | NAAT 1 | | NAAT 2 | | NeuMoDx | | Count | | |
|---------|--------|-------|--------|-------|---------|-------|-------|--------|-------|
| Overall | CCVS | Urine | CCVS | Urine | SCVS | Urine | Symp. | Asymp. | Total |
| NI | NA | NA | - | - | - | NA | 1 | 0 | 1 |
| NI | - | NA | - | NA | - | - | 0 | 2 | 2 |
| NI | - | NA | - | - | - | NA | 2 | 0 | 2 |
| NI | - | NA | - | - | - | - | 6 | 3 | 9 |
| NI | - | NA | - | - | - | UNR | 4 | 0 | 4 |
| NI | NA | - | NA | - | - | - | 2 | 2 | 4 |
| NI | NA | - | - | - | - | - | 10 | 4 | 14 |
| NI | - | - | - | NA | - | - | 0 | 1 | 1 |
| NI | - | - | NA | - | - | - | 1 | 0 | 1 |

{14}------------------------------------------------

| PIS | NAAT 1 | | NAAT 2 | | NeuMoDx | | Count | | |
|---------------------------------------------------------------------------------------------|--------|-------|--------|-------|---------|-------|-------|--------|-------|
| Overall | CCVS | Urine | CCVS | Urine | SCVS | Urine | Symp. | Asymp. | Total |
| NI | - | - | - | - | - | NA | 5 | 0 | 5 |
| NI | - | - | - | - | - | IND | 0 | 1 | 1 |
| NI | - | - | - | - | NA | - | 6 | 4 | 10 |
| NI | - | - | - | - | - | - | 904 | 1011 | 1915 |
| NI | - | - | - | - | + | - | 1 | 0 | 1 |
| NI | - | - | - | - | + | + | 1 | 0 | 1 |
| NI | - | - | - | - | - | UNR | 5 | 2 | 7 |
| NI | - | - | + | - | - | - | 0 | 1 | 1 |
| NI | - | + | - | - | - | - | 1 | 1 | 2 |
| Total | | | | | | | 949 | 1032 | 1981 |
| I | + | - | + | - | + | - | 0 | 1 | 1 |
| I | + | + | + | EQ | + | + | 0 | 1 | 1 |
| I | + | + | + | - | + | + | 0 | 1 | 1 |
| I | + | + | + | + | - | - | 1 | 0 | 1 |
| I | + | + | + | + | + | - | 0 | 1 | 1 |
| I | + | + | + | + | + | + | 20 | 20 | 40 |
| Total | | | | | | | 21 | 24 | 45 |
| SCVS = Self-Collected Vaginal Swab<br>IND = Indeterminate. UNR = Unresolved. EQ = Equivocal | | | | | | | | | |

NI = Non-infected, I = Infected, NA = Not Available

# Indeterminate or Unresolved Result Rates

Invalid (indeterminate or unresolved) rates were calculated for each of the NeuMoDx Molecular Systems (N96 and N288), and for the instruments combined. Among all specimen types, instrument models, targets and symptom status, 1/5738 (0.0%; 95% CI 0.0%-0.1%) were Indeterminate (IND) and 12/5738 (0.2%; 95% CI: 0.1% to 0.4%) were Unresolved (UNR).

# Performance Characteristics - Non-Clinical Studies

# Precision/Reproducibility

# Within-Laboratory Precision

The within-laboratory precision study was conducted using three (3) NeuMoDx 288 Molecular Systems and three (3) NeuMoDx 96 Molecular Systems over 12 days. The precision panel was prepared using two (2) specimen matrices, urine and universal transport medium, and included negative, low positive, moderate positive, and high negative samples for both Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Low and moderate positive panel members were subjected to nested ANOVA analysis to establish repeatability (between replicates), between day, within system, between system, and within laboratory (total) precision, the results of which are presented Tables 8 - 11 below

{15}------------------------------------------------

| | | | Table 8: Within Lab Precision of NeuMoDx CT/NG Assay 2.0 for CT target, N96 | | | |
|--------|--|--|-----------------------------------------------------------------------------|--|--|--|
| System | | | | | | |

| Matrix | CT<br>Level | Ct<br>Avg | n | %<br>Agreement†<br>(95% CI) | Repeatability | | Between Run | | Between Day | | Within<br>System | | Between<br>System | | Within<br>Lab | |
|--------|-------------|-----------|-----|-----------------------------|---------------|-----|-------------|-----|-------------|-----|------------------|-----|-------------------|-----|---------------|-----|
| | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Swab | MC | 29.7 | 216 | 100<br>(98.2-100) | 0.614 | 2.1 | 0.191 | 0.6 | 0.000 | 0.0 | 0.643 | 2.2 | 0.104 | 0.3 | 0.651 | 2.2 |
| | LC* | 31.7 | 432 | 100<br>(99.1-100) | 0.771 | 2.4 | 0.196 | 0.6 | 0.000 | 0.0 | 0.795 | 2.5 | 0.115 | 0.4 | 0.803 | 2.5 |
| | HN | N/A | 218 | 16.5<br>(12.7-22.0) | N/A | | | | | | | | | | | |
| | N | N/A | 216 | 99.5<br>(97.4-99.9) | N/A | | | | | | | | | | | |
| Urine | MC | 30.1 | 216 | 100<br>(98.2-100) | 0.545 | 1.8 | 0.300 | 1.0 | 0.101 | 0.3 | 0.630 | 2.1 | 0.094 | 0.3 | 0.637 | 2.1 |
| | LC* | 32.0 | 432 | 100<br>(99.1-100) | 0.648 | 2.0 | 0.294 | 0.9 | 0.108 | 0.3 | 0.720 | 2.2 | 0.056 | 0.2 | 0.722 | 2.3 |
| | HN | N/A | 215 | 14.4<br>(10.2-20.0) | N/A | | | | | | | | | | | |
| | N | N/A | 215 | 99.5<br>(97.4-99.9) | N/A | | | | | | | | | | | |

MC = Moderate CT, LC=Low CT, HN = High Neg, N = Negative

*Low level data pooled from two panel members

†% Agreement with expected results

Table 9: Within Lab Precision of NeuMoDx CT/NG Assay 2.0 for CT target, N288 System

| Matrix | CT<br>Level | Ct<br>Avg | n | %<br>Agreement†<br>(95% CI) | Repeatability | | Between Run | | Between Day | | Within<br>System | | Between<br>System | | Within<br>Lab | |
|--------|-------------|-----------|-----|-----------------------------|---------------|-----|-------------|-----|-------------|-----|------------------|-----|-------------------|-----|---------------|-----|
| | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Swab | MC | 29.6 | 216 | 100<br>(98.2-100) | 0.733 | 2.5 | 0.000 | 0.0 | 0.303 | 1.0 | 0.793 | 2.7 | 0.099 | 0.3 | 0.799 | 2.7 |
| | LC* | 31.7 | 431 | 100<br>(99.1-100) | 0.771 | 2.4 | 0.082 | 0.3 | 0.193 | 0.6 | 0.799 | 2.5 | 0.133 | 0.4 | 0.810 | 2.6 |
| | HN | N/A | 216 | 14.4<br>(10.3-19.6) | N/A | | | | | | | | | | | |
| | N | N/A | 217 | 100<br>(98.3-100) | N/A | | | | | | | | | | | |
| Urine | MC | 29.9 | 215 | 100<br>(98.2-100) | 0.702 | 2.3 | 0.079 | 0.3 | 0.117 | 0.4 | 0.716 | 2.4 | 0.158 | 0.5 | 0.734 | 2.5 |
| | LC* | 31.9 | 432 | 100<br>(99.1-100) | 0.646 | 2.0 | 0.096 | 0.3 | 0.128 | 0.4 | 0.666 | 2.1 | 0.000 | 0.0 | 0.666 | 2.1 |
| | HN | N/A | 216 | 16.2<br>(11.7-22.0) | N/A | | | | | | | | | | | |
| | N | N/A | 215 | 100<br>(98.2-100) | N/A | | | | | | | | | | | |

MC = Moderate CT, LC= Low CT, HN = High Neg, N = Negative

*Low level data pooled from two panel members

*% Agreement with expected results

{16}------------------------------------------------

| Matrix | CT<br>Level | Ct<br>Avg | n | %<br>Agreement†<br>(95% CI) | Repeatability | | Between Run | | Between Day | | Within System | | Between System | | Within Lab | |
|--------|-------------|-----------|-----|-----------------------------|---------------|-----|-------------|-----|-------------|-----|---------------|-----|----------------|-----|------------|-----|
| |…