Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on automated sample preparation and real-time PCR for nucleic acid detection. The software interprets results based on amplification status and controls, which is standard for PCR assays and does not indicate AI/ML. There is no mention of AI, ML, or related terms in the summary.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of DNA from certain bacteria and parasites to aid in diagnosis, not for treating a condition.

Diagnostic

Yes

Explanation: The device is explicitly stated to "aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis" by detecting specific DNA in patient samples. This function directly supports the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the BD MAX System and the BD MAX CTGCTV2 are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. This indicates the presence of significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states the device is for the "direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV)" in various patient specimens (vaginal swabs, urine, endocervical swabs, LBC). This is a classic description of an in vitro diagnostic test, which is performed on samples taken from the human body to provide information for diagnosis.
Device Description: The description details the components of the system, including reagents, cartridges, and an instrument that automates sample preparation and performs real-time PCR for nucleic acid amplification and detection. This process is conducted outside of the living organism (in vitro).
Clinical Performance Studies: The document describes clinical trials where patient specimens were tested with the device to evaluate its performance (sensitivity, specificity) in aiding the diagnosis of specific diseases (chlamydial urogenital disease, gonococcal urogenital disease, and trichomoniasis). This is a key characteristic of an IVD, which is used to provide diagnostic information.
Analytical Performance: The analytical studies described (precision, reproducibility, sensitivity, specificity, etc.) are standard evaluations performed on IVDs to ensure their reliability and accuracy.
Predicate Device: The mention of a predicate device (K151589; BD MAX™ CT/GC/TV) which is also an IVD, further supports that this device falls under the same category.

The device is designed to be used on patient specimens in vitro to aid in the diagnosis of specific infections, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BD MAX™ CTGCTV2 assay, performed on the BD MAX™ System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:

Chlamydia trachomatis (CT) ●
Neisseria gonorrhoeae (GC) ●
Trichomonas vaginalis (TV) ●

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

Product codes (comma separated list FDA assigned to the subject device)

OUY, MKZ, LSL

Device Description

The BD MAX System and the BD MAX CTGCTV2 are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. A test result may be called as POS, NEG, UNR, IND or INC for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System level failure.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Patient- or clinician-collected vaginal swab specimens, male and female urine specimens, endocervical swab and Liquid-Based Cytology (LBC) specimens.

Indicated Patient Age Range

18 and over

Intended User / Care Setting

Clinicians in a clinical setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Clinical Performance Studies:
Test Set Sample Size: 2,547 female subjects and 1,159 male subjects. The final data analysis included 2,536 evaluable female subjects and 1,149 evaluable male subjects.
Data Source: Twelve geographically diverse clinical sites in North America.
Annotation Protocol: For Chlamydia trachomatis and Neisseria gonorrhoeae, the female Patient Infected Status (PIS) was established by testing urine and cervical specimens with two different FDA cleared NAATs, where female subjects were designated as infected if at least two different reference NAATs were positive for urine and cervical specimens. Females who tested positive with the two comparator NAATs in urine only (negative in swabs with both NAATs), were considered non-infected when calculating the performance of the assay for swab specimens. The male PIS was established by testing urine specimens using up to three different FDA cleared NAATs where male subjects were designated as infected if 2 out of 3 reference NAAT results were positive. Subjects were categorized as non-infected if 2 out of 3 reference NAAT results were negative.
For Trichomonas vaginalis, the female PIS was established by testing vaginal specimens with two different FDA cleared molecular tests, across three different instrument platforms, where female subjects were designated as infected if 2 out of 3 reference test results were positive. Subjects were categorized as non-infected if 2 out of 3 reference test results were negative. The male PIS was established by testing urine specimens using up to three different FDA cleared NAATs where male subjects were designated as infected if 2 out of 3 reference test results were positive. Subjects were categorized as non-infected if 2 out of 3 reference test results were negative.
For female urine, the clinical performance was calculated compared to a Composite Comparator Algorithm (CCA) utilizing urine samples from up to three reference NAATs to generate reference results for each analyte. Female subjects were designated as positive if 2 out of 3 reference NAAT results were positive. Subjects were categorized as negative if 2 out of 3 reference NAAT results were negative.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance:

Precision: Evaluated at one site with one reagent lot over 12 days (2 runs/day, 2 technologists, 24 total runs). Test samples contrived in female urine, vaginal swab clinical matrix, and PreservCyt LBC specimen matrix with CT, GC, and TV panel members tested in two replicates. Target concentrations: Moderate Positive (3X LoD), Low Positive (1.5X LoD), High Negative (

Regulation Number and Section

§ 866.3860

Trichomonas vaginalis nucleic acid assay.(a)
Identification. ATrichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused byTrichomonas vaginalis .(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection ofTrichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.

Summary

0

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 8, 2019

Becton, Dickinson and Company Katie Edwards Regulatory Affairs Project Manager 7 Loveton Circle Sparks, Maryland 21152

Re: K182692

Trade/Device Name: BD MAX CTGCTV2, BD MAX System Regulation Number: 21 CFR 866.3860 Regulation Name: Trichomonas vaginalis nucleic acid assay Regulatory Class: Class II Product Code: OUY, MKZ, LSL Dated: January 4, 2019 Received: January 7, 2019

Dear Katie Edwards:

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 (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 located 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.

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

1

801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Uwe Scherf -S

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K182692

Device Name BD MAX™ CTGCTV2

Indications for Use (Describe)

The BD MAX™ CTGCTV2 assay, performed on the BD MAX™ System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:

Chlamydia trachomatis (CT) ●
Neisseria gonorrhoeae (GC) ●
Trichomonas vaginalis (TV) ●

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

Ancillary Collection kits:

The BD MAX 3-in-1 Swab Collection Kit is intended to be used in clinical settings according to the instructions provided for collection and transport of vaginal and endocervical swab specimens. This transport system is for use for testing with BD MAX products.

The BD MAX Urine Transport Kit is intended to be used in clinical settings according to the instructions provided for collection, preservation and transport of urine specimens. This transport system is for use for testing with the BD MAX products.

The BD MAX LBC Sample Buffer Tubes are intended to be used in clinical settings according to the instructions provided for the preservation and transport of Liquid-Based Cytology (LBC) specimens. This transport system is for use for testing with the BD MAX products.

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

区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

3

" An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 EF

4

510(k) Summary BD MAX™ CTGCTV2

Summary Preparation Date:

12/28/2018

Submitted by:

BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Contact:

Katie Edwards Regulatory Affairs Project Manager Tel: 410-316-4975 Email: Katie_Edwards@bd.com

Proprietary Names:

For the instrument: BD MAX™ System For the assay: BD MAX CTGCTV2

Common Names:

For the instrument: Bench-top molecular diagnostics workstation

For the assay: CT assay GC assay TV assay

Regulatory Information

Regulation section: 866.3860 – Trichomonas vaginalis Nucleic Acid Amplification Test System Classification: Class II

5

Panel: Microbiology (83)

Product Code(s):

MKZ Chlamydia trachomatis

LSL Neisseria gonorrhoeae
OUY Trichomonas vaginalis

Predicate Device:

BD MAX™ CT/GC/TV [510(k) K151589]

Performance Standards:

Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis, August 4, 2015.

Intended Use:

The BD MAX™ CTGCTV2 assay, performed on the BD MAX™ System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:

Chlamydia trachomatis (CT)
Neisseria gonorrhoeae (GC)
Trichomonas vaginalis (TV) ●

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

Special Conditions for Use Statement: For prescription use

Special Instrument Requirements: BD MAX System

Device Description:

The BD MAX System and the BD MAX CTGCTV2 are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, and extraction reagents. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX System software automatically interprets test results. A test result may be called

6

as POS, NEG, UNR, IND or INC for each of the assay's targets, based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX System level failure.

Test Principle:

The BD MAX CTGCTV2 assay is designed for use with the applicable BD MAX specimen collection and transport devices, including the BD MAX™ Urine Transport Kit, the BD MAX™ LBC Sample Buffer Tubes or the BD MAX™ 3-in-1 Swab Collection Kit. The specimen is collected from the patient and transported to the testing laboratory using the appropriate transport device under conditions of time and temperature that have been determined to maintain the integrity of the target nucleic acids.

LBC samples are pre-warmed on the BD Pre-warm Heater hefore testing on the BD MAX System. None of the other specimen types undergo a pre-warm step. The Sample Buffer Tubes are recapped with a septum cap prior to processing on the BD MAX System. A worklist is created and the Sample Buffer Tube, the BD MAX CTGCTV2 Unitized Reagent Strip and the BD MAX PCR Cartridge are loaded onto the BD MAX System. The BD MAX System automates sample preparation, including target organism lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The BD MAX System performs results interpretation automatically. The assay also includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The Sample Processing Control monitors DNA extraction steps, thermal cycling steps, reagent integrity and presence of inhibitory substances.

Nucleic acids that are released from the target organisms as a result of cell lysis during the extraction process are captured on magnetic affinity beads. together with the bound nucleic acids, are washed using Wash Buffer and the nucleic acids are eluted by a combination of heat and pH. Eluted DNA is neutralized using Neutralization Buffer and transferred to the Master Mix to rehydrate the PCR reagents. After reconstitution, the BD MAX System dispenses a fixed volume of PCR-ready solution containing extracted nucleic acids into the BD MAX PCR Cartridge. Microvalves in the BD MAX PCR Cartridge are sealed by the system prior to initiating PCR in order to contain the amplification mixture, thus preventing evaporation and contamination.

The BD MAX CTGCTV2 assay is comprised of two targets for Chlamydia trachomatis (detected on the same optical channel), two targets for Neisseria gonorrhoeae (detected on two different optical channels) and one target for Trichomonas vaginalis (detected on one optical channel). Only one Chlamydia trachomatis target is required to be positive in order to report a positive result. Both Neisseria gonorrhoeae targets are required to be positive in order to report a positive result. The amplified DNA targets are detected using hydrolysis (TaqMan®) probes, labeled at one end with a fluorescent reporter dye (fluorophore), and at the other end, with a quencher moiety. Probes labeled with different fluorophores are used to detect amplicons for target analytes and the Sample Processing Control in five different optical channels of the BD MAX System. When the probes are in their native state, the fluorescence of the fluorophore is quenched due to its proximity to the quencher. However, in the presence of target DNA, the probes hybridize to their complementary sequences and are hydrolyzed by the 5 - 3' exonuclease activity of the DNA polymerase as it synthesizes the nascent strand along the DNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The BD MAX System monitors these signals at the end of each cycle and interprets the data at the end of the reaction to provide qualitative test results for each analyte (i.e., positive or negative).

Substantial Equivalence:

Table 1 provides the similarities and differences between the BD MAX CTGCTV2 and the predicate device.

7

Items	BD MAX CTGCTV2	BD MAX CT/GC/TV
510(k)#	K182692	K151589
Regulation	866.3860	866.3860
Product Code	MKZ, LSL, OUY	MKZ, LSL, OUY
Device Class	II	II
Intended Use	The BD MAX CTGCTV2 assay, performed on the BD MAX System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:
Chlamydia trachomatis (CT)
Neisseria gonorrhoeae (GC)
Trichomonas vaginalis (TV)
The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test.
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.	The BD MAX CT/GC/TV assay, as performed using the BD MAX System incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and/or Trichomonas vaginalis (TV). The assay may be used for detection of CT and/or GC DNA in male urine specimens, and the detection of CT, GC and/or TV DNA in female urine specimens, clinician-collected female endocervical swab specimens and patient-collected vaginal swab specimens (in a clinical setting). The assay is indicated for use to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis in asymptomatic and symptomatic individuals.
Indications
for Use	Asymptomatic and Symptomatic Patients	Asymptomatic and Symptomatic Patients
Specimen Type	Clinician-collected vaginal swab, patient-collected vaginal swab, endocervical swab, PreservCyt LBC, female and male urine	Endocervical swab, patient-collected vaginal swab, female and male urine
Technology	PCR	PCR
Organisms Detected	CT, GC and TV	CT, GC and TV
Sample Prep /
Interpretation of
Results	Automated by BD MAX System	Automated by BD MAX System
Assay Controls	Sample Processing Control
	Target	Dye	Channel
Target Detection	CT	FAM	FAM
	CT	FAM	FAM
	GC (GC1)	CFO	VIC
	GC (GC2)	Q705	CY5.5
	TV	Q670	CY5
Collection/
Transport Device	Swab Sample Buffer Tube (2.0 mL)
Urine Sample Buffer Tube (0.5 mL)
LBC Sample Buffer Tube (1.5 mL)	UVE Sample Buffer Tube (1.5 mL)
Sample Prep	1 swab added to Swab Sample Buffer Tube
2.0 mL urine added to Urine Sample Buffer
Tube	1 swab or 1.0 mL urine added to UVE
Sample Buffer Tube

Table 1:	Comparison to Predicate Device
----------	--------------------------------

8

ª Detection of both GC1 and GC2 gene targets required to report a positive result.

Analytical Performance

Precision

Within-laboratory precision was evaluated for the BD MAX CTGCTV2 assay at one site with one reagent lot. Testing was performed over 12 days, with 2 runs per day (2 technologists, alternating operators each day), for a total of 24 runs. Test samples were contrived in female urine, in vaginal swab clinical matrix and in PreservCyt LBC specimen matrix and included Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis panel member was tested in two replicates.

9

The following target concentrations were used for spiking levels of the target organisms contained in each panel member:

Moderate Positive (MP): 3X LoD
Low Positive (LP): 1.5X LoD
. High Negative (HN): Chlamydia trachomatis
(n), 95% CI | | | Neisseria gonorrhoeae
(n), 95% CI | | | Trichomonas vaginalis
(n), 95% CI | |
|----------|---------------------------------------------|-----------|-----------|---------------------------------------------|-----------|-----------|---------------------------------------------|-----------|
| | Swab | Urine | LBCc | Swab | Urine | LBCc | Swab | Urine |
| TNa | 100% | 100% | 99.4% | 100% | 100% | 100% | 100% | 100% |
| | (336/336) | (336/336) | (334/336) | (336/336) | (336/336) | (336/336) | (336/336) | (336/336) |
| | 98.9-100 | 98.9-100 | 97.9-99.8 | 98.9-100 | 98.9-100 | 98.9-100 | 98.9-100 | 98.9-100 |
| HNb | 31.3% | 31.3% | 18.8% | 27.1% | 29.2% | 16.7% | 37.5% | 68.8% |
| | (15/48) | (15/48) | (9/48) | (13/48) | (14/48) | (8/48) | (18/48) | (33/48) |
| | 19.9-45.3 | 19.9-45.3 | 10.2-31.9 | 16.6-41.0 | 18.2-43.2 | 8.7-29.6 | 25.2-51.6 | 54.7-80.1 |
| LP | 100% | 100% | 100% | 97.9% | 100% | 100% | 97.9% | 100% |
| | (48/48) | (48/48) | (48/48) | (47/48) | (48/48) | (48/48) | (47/48) | (48/48) |
| | 92.6-100 | 92.6-100 | 92.6-100 | 89.1-99.6 | 92.6-100 | 92.6-100 | 89.1-99.6 | 92.6-100 |
| MP | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| | (48/48) | (48/48) | (48/48) | (48/48) | (48/48) | (48/48) | (48/48) | (48/48) |
| | 92.6-100 | 92.6-100 | 92.6-100 | 92.6-100 | 92.6-100 | 92.6-100 | 92.6-100 | 92.6-100 |

Table 2: Overall Precision Study Results (Percent Agreement with Expected Results)

a For the True Negative (TN) category, the reported agreement indicates the percent of negative results. b For the High Negative (HN) category, the reported agreement indicates the percent of positive results.

° PreservCyt LBC

Reproducibility

For the Site-to-Site reproducibility study, three sites (2 external and one internal) were provided the same panels as described for the Precision study, above. Each site performed testing on eight distinct days (consecutive or not), wherein each day, two panels were tested by two technologists (alternating operators each day).

All targets ranged from 99.6% to 100% for TN, 11.5% to 78.1% for HN, 97.9% to 100% for LP and 97.9% to 100% for MP categories (Table 3). Ct score, internal criterion used to determine a final assay result, was selected as an additional means of assessing assay reproducibility. Overall mean Ct score values with variance components (SD and %CV) are shown in Tables Table 4 through Table 6.

10

| Category | Chlamydia trachomatis
(n), 95% CI | | | Neisseria gonorrhoeae
(n), 95% CI | | | Trichomonas vaginalis
(n), 95% CI | |
|----------|--------------------------------------|---------------------------------|-------------------------------|--------------------------------------|-------------------------------|-------------------------------|--------------------------------------|--------------------------------|
| | Swab | Urine | LBCc | Swab | Urine | LBCc | Swab | Urine |
| | TNa | 99.6%
(669/672)
98.7-99.8 | 100%
(672/672)
99.4-100 | 100%
(672/672)
99.4-100 | 100%
(672/672)
99.4-100 | 100%
(672/672)
99.4-100 | 99.9%
(671/672)
99.2-100 | 99.9%
(671/672)
99.2-100 |
| HNb | 20.8%
(20/96)
13.9-30.0 | 35.4%
(34/96)
26.6-45.4 | 21.9%
(21/96)
14.8-31.1 | 34.4%
(33/96)
25.6-44.3 | 28.1%
(27/96)
20.1-37.8 | 11.5%
(11/96)
6.5-19.4 | 37.5%
(36/96)
28.5-47.5 | 78.1%
(75/96)
68.9-85.2 |
| LP | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 99.0%
(95/96)
94.3-99.8 | 99.0%
(95/96)
94.3-99.8 | 97.9%
(94/96)
92.7-99.4 | 99.0%
(95/96)
94.3-99.8 | 99.0%
(95/96)
94.3-99.8 |
| MP | 100%
(96/96)
96.2-100 | 99.0%
(95/96)
94.3-99.8 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 97.9%
(94/96)
92.7-99.4 |

Table 3: MAX CTGCTV2 Site-to-Site Reproducibility Study Results (Percent Agreement with Expected Results)

ª For the True Negative (TN) category, the reported agreement indicates the percent of negative results.

b For the High Negative (HN) category, the reported agreement indicates the percent of positive results. ° PreservCyt LBC

Table 4:	C. trachomatis Site-to-Site Quantitative Reproducibility Across Sites with Pooled
	Days, Runs and Replicates

| Matrix
Type | Cat | Agree
/N | Mean | Within Run | | Between Run | | Between
Day | | Between
Operator | | Between
Site | | Total | |
|----------------|-----|-------------|------|------------|-----|-------------|-----|----------------|-----|---------------------|-----|-----------------|-----|-------|-----|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Swab | HN | 20/96 | 36.6 | 1.1 | 3.1 | 1.8 | 4.9 | 0.1 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 2.1 | 5.8 |
| Swab | LP | 96/96 | 33.2 | 0.7 | 2.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.7 | 2.1 |
| Swab | MP | 96/96 | 32.1 | 0.6 | 2.0 | 0.0 | 0.0 | 0.2 | 0.5 | 0.0 | 0.0 | 0.1 | 0.4 | 0.7 | 2.1 |
| Urine | HN | 34/96 | 36.8 | 1.6 | 4.3 | 0.0 | 0.0 | 0.8 | 2.1 | 0.0 | 0.0 | 0.4 | 1.0 | 1.8 | 4.9 |
| Urine | LP | 96/96 | 32.9 | 0.7 | 2.3 | 0.0 | 0.0 | 0.7 | 2.0 | 0.3 | 0.9 | 0.0 | 0.0 | 1.1 | 3.2 |
| Urine | MP | 95/96 | 33.9 | 1.1 | 3.1 | 0.1 | 0.4 | 0.2 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 1.1 | 3.2 |
| LBCa | HN | 21/96 | 38.1 | 0.7 | 1.9 | 2.0 | 5.1 | 0.0 | 0.0 | 1.4 | 3.8 | 0.0 | 0.0 | 2.5 | 6.6 |
| LBCa | LP | 96/96 | 34.6 | 1.1 | 3.2 | 0.4 | 1.2 | 0.3 | 0.9 | 0.0 | 0.0 | 0.7 | 2.0 | 1.4 | 4.0 |
| LBCa | MP | 96/96 | 33.1 | 0.6 | 1.8 | 0.0 | 0.0 | 0.2 | 0.7 | 0.0 | 0.0 | 0.2 | 0.7 | 0.7 | 2.1 |

a PreservCyt LBC

11

| Target | Matrix
Type | Cat | Agree/
N | Mean | Within
Run | | Between
Run | | Between
Day | | Between
Operator | | Between
Site | | Total | |
|--------|----------------|-----|------ | | | | | GC1 | Swab | HN | 33/96 | | Swab | LP | 95/96 | | Swab | MP | 96/96 | GC1 | Urine | HN | 27/96 | | Urine | LP | 95/96 | | Urine | MP | 96/96 | GC1 | LBCa | HN | 11/96 | | LBCa | LP | 94/96 | | LBCa | MP | 96/96 | GC2 | Swab | HN | 33/96 | | Swab | LP | 95/96 | | Swab | MP | 96/96 | GC2 | Urine | HN | 27/96 | | Urine | LP | 95/96 | | Urine | MP | 96/96 | GC2 | LBCa | HN | 11/96 | | LBCa | LP | 94/96 | | LBCa | MP | 96/96 -------|------|---------------|-----|----------------|-----|----------------|-----|---------------------|-----|-----------------|-----|-------|-----|
| | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 36.3 | 2.1 | 5.7 | 0.9 | 2.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.6 | 1.7 | 2.3 | 6.4 |
| 32.5 | 0.9 | 2.8 | 0.0 | 0.0 | 0.3 | 0.9 | 0.0 | 0.0 | 0.1 | 0.3 | 1.0 | 2.9 |
| 31.4 | 0.5 | 1.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.1 | 0.2 | 0.5 | 1.5 |
| 36.5 | 2.1 | 5.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.7 | 2.0 | 2.2 | 6.1 |
| 32.5 | 1.1 | 3.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.5 | 1.1 | 3.5 |
| 32.8 | 0.9 | 2.6 | 0.4 | 1.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.0 | 2.9 |
| 35.5 | 1.4 | 3.9 | 0.0 | 0.0 | 0.9 | 2.7 | 0.0 | 0.0 | 0.0 | 0.0 | 1.7 | 4.7 |
| 32.1 | 0.5 | 1.6 | 0.4 | 1.2 | 0.3 | 1.0 | 0.1 | 0.4 | 0.1 | 0.4 | 0.7 | 2.3 |
| 30.7 | 0.5 | 1.5 | 0.5 | 1.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.4 | 1.2 | 0.7 | 2.4 |
| 34.2 | 1.1 | 3.2 | 0.1 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.1 | 3.2 |
| 30.9 | 0.7 | 2.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.7 | 2.2 |
| 29.8 | 0.4 | 1.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.4 | 0.2 | 0.7 | 0.4 | 1.5 |
| 34.8 | 1.4 | 4.0 | 0.9 | 2.5 | 0.0 | 0.0 | 0.4 | 1.1 | 0.5 | 1.5 | 1.8 | 5.1 |
| 31.0 | 0.7 | 2.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.2 | 0.0 | 0.0 | 0.7 | 2.4 |
| 31.2 | 0.6 | 1.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.8 | 0.6 | 2.1 |
| 35.3 | 0.8 | 2.2 | 1.1 | 3.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.8 | 2.3 | 1.6 | 4.5 |
| 30.5 | 0.4 | 1.2 | 0.4 | 1.3 | 0.3 | 1.1 | 0.0 | 0.0 | 0.2 | 0.8 | 0.7 | 2.2 |
| 29.2 | 0.3 | 1.1 | 0.4 | 1.3 | 0.2 | 0.7 | 0.1 | 0.5 | 0.3 | 1.0 | 0.6 | 2.2 |

N. gonorrhoeae Site-to-Site Quantitative Reproducibility Across Sites with Pooled Table 5: Days, Runs and Replicates

a PreservCyt LBC

Table 6: T. vaginalis Site-to-Site Quantitative Reproducibility Across Sites with Pooled Days, Runs and Replicates

| Matrix
Type | Cat | N/ Sus | | | | | | | | | | | | | Mean | Within Run | | Between Run | | Between
Day | | Between
Operator | | Between
Site | | Total | |
|----------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|-----|------|------------|--|-------------|--|----------------|--|---------------------|--|-----------------|--|-------|--|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | | | | | | | | | | | |
| Swab | HN | 36/96 | 36.9 | 1.8 | 5.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.8 | 5.0 | | | | | | | | | | | | |
| | LP | તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય | 33.2 | 0.7 | 2.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.7 | 0.8 | 2.3 | | | | | | | | | | | | |
| | MP | તે જિલ્લાનું મુખ્યત્વે ખેત-ઉત્પાદન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની | 32.3 | 0:5 | 1.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.3 | 0.0 | 0.0 | 0:5 | 1.6 | | | | | | | | | | | | |
| | HN | 75/96 | 37.2 | 2.4 | 6.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.4 | 6.6 | | | | | | | | | | | | |
| Urine | LP | તે તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી | 32.5 | 0.7 | 2.2 | 0.0 | 0.0 | 0.3 | 0.9 | 0.2 | 0.6 | 0.2 | 0:5 | 0.8 | 2.5 | | | | | | | | | | | | |
| | MP | 94/96 | 33.7 | 0.8 | 2.4 | 0.3 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.9 | 2.6 | | | | | | | | | | | | |

For the Lot-to-Lot reproducibility study, two operators each completed a single run of each panel member on two instruments for each of three lots of reagents over an 8-day period, at one testing site. The panels used were the same as described under the Precision heading, above. Results from one reagent lot of the site to site reproducibility study were used to comprise data for one lot of reagents for the Lot-to-Lot study.

The overall Lot-to-Lot reproducibility percent agreement across all targets ranged from 99.4% to 100% for TN, 10.4% to 75.0% for HN, 95.8% to 100% for LP and 95.8% to 100% for MP categories (Table 7). The Lot-to-Lot quantitative reproducibility according to Ct score is also shown in Table 8 to Table 10.

12

| Category | Chlamydia trachomatis
(n), 95% CI | | | Neisseria gonorrhoeae
(n), 95% CI | | | Trichomonas vaginalis
(n), 95% CI | |
|----------|--------------------------------------|-------------------------------|---------------------------------|--------------------------------------|-------------------------------|-------------------------------|--------------------------------------|-------------------------------|
| | Swab | Urine | LBCc | Swab | Urine | LBCc | Swab | Urine |
| TNa | 99.4%
(668/672)
98.5-99.8 | 100%
(672/672)
99.4-100 | 99.6%
(669/672)
98.7-99.8 | 99.9%
(671/672)
99.2-100 | 100%
(672/672)
99.4-100 | 100%
(672/672)
99.4-100 | 100%
(672/672)
99.4-100 | 100%
(672/672)
99.4-100 |
| HNb | 22.9%
(22/96)
15.6-32.3 | 37.5%
(36/96)
28.5-47.5 | 15.6%
(15/96)
9.7-24.2 | 24.0%
(23/96)
16.5-33.4 | 24.0%
(23/96)
16.5-33.4 | 10.4%
(10/96)
5.8-18.1 | 40.6%
(39/96)
31.3-50.6 | 63.5%
(61/96)
53.6-72.5 |
| LP | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 99.0%
(95/96)
94.3-99.8 | 99.0%
(95/96)
94.3-99.8 | 95.8%
(92/96)
89.8-98.4 | 100%
(96/96)
96.2-100 | 99.0%
(95/96)
94.3-99.8 | 99.0%
(95/96)
94.3-99.8 |
| MP | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 95.8%
(92/96)
89.8-98.4 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 | 100%
(96/96)
96.2-100 |

Table 7: Lot-to-Lot Reproducibility (Percent Agreement with Expected Results)

ª For the True Negative (TN) category, the reported agreement indicates the percent of negative results.

b For the High Negative (HN) category, the reported agreement indicates the percent of positive results. ° PreservCyt LBC

Chlamydia trachomatis Lot-to-Lot Quantitative Reproducibility Study Results Table 8:

| Matrix
Type | Cat | Agree
/N | Mean | Within Run | | Between Run | | Between
Day | | Between
Operator | | Between
Lot | | Total | |
|----------------|-----|-------------|------|------------|-----|-------------|-----|----------------|-----|---------------------|-----|----------------|-----|-------|-----|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Swab | HN | 22/96 | 37.3 | 1.1 | 2.9 | 2.2 | 5.9 | 1.2 | 3.1 | 0.0 | 0.0 | 0.0 | 0.0 | 2.7 | 7.3 |
| | LP | 96/96 | 33.6 | 1.0 | 2.9 | 0.4 | 1.2 | 0.0 | 0.0 | 0.2 | 0.6 | 0.3 | 0.7 | 1.1 | 3.3 |
| | MP | 96/96 | 32.6 | 0.8 | 2.3 | 0.0 | 0.0 | 0.3 | 1.0 | 0.1 | 0.4 | 0.1 | 0.3 | 0.8 | 2.6 |
| Urine | HN | 36/96 | 38.0 | 2.9 | 7.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.3 | 0.8 | 3.0 | 7.8 |
| | LP | 96/96 | 32.9 | 0.6 | 1.8 | 0.5 | 1.6 | 0.0 | 0.0 | 0.2 | 0.5 | 0.0 | 0.0 | 0.8 | 2.4 |
| | MP | 96/96 | 34.0 | 1.0 | 3.0 | 0.1 | 0.4 | 0.0 | 0.0 | 0.3 | 0.8 | 0.2 | 0.6 | 1.1 | 3.2 |
| LBCa | HN | 15/96 | 38.8 | 1.8 | 4.7 | 1.4 | 3.6 | 0.0 | 0.0 | 1.2 | 3.0 | 0.0 | 0.0 | 2.6 | 6.7 |
| | LP | 95/96 | 34.8 | 1.1 | 3.0 | 0.4 | 1.0 | 0.0 | 0.0 | 0.3 | 0.9 | 0.0 | 0.0 | 1.2 | 3.3 |
| | MP | 96/96 | 33.4 | 0.7 | 2.0 | 0.3 | 1.0 | 0.4 | 1.3 | 0.2 | 0.7 | 0.0 | 0.0 | 0.9 | 2.7 |

a PreservCyt LBC

13

| Target | Matrix
Type | Cat | Agree
/N | Mean | Within Run | | Between Run | | Between
Day | | Between
Operator | | Between
Lot | | Total | |
|--------|----------------|-----|-------------|------|------------|-----|-------------|-----|----------------|-----|---------------------|-----|----------------|-----|-------|------|
| | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| GC1 | Swab | HN | 23/96 | 36.4 | 1.5 | 4.1 | 0.0 | 0.0 | 1.3 | 3.6 | 1.0 | 2.9 | 1.1 | 2.9 | 2.5 | 6.8 |
| | | LP | 95/96 | 32.7 | 1.5 | 4.4 | 0.6 | 1.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.6 | 4.7 |
| | | MP | 96/96 | 31.6 | 0.7 | 2.2 | 0.1 | 0.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.7 | 0.8 | 2.4 |
| GC1 | Urine | HN | 23/96 | 36.8 | 2.5 | 6.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.7 | 2.0 | 2.6 | 7.1 |
| | | LP | 92/96 | 32.6 | 1.3 | 4.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.2 | 1.3 | 4.0 |
| | | MP | 92/96 | 32.8 | 0.9 | 2.8 | 0.2 | 0.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.2 | 1.0 | 2.9 |
| | LBC a | HN | 10/96 | 37.8 | 2.9 | 7.6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.5 | 9.4 | 4.6 | 12.1 |
| | | LP | 96/96 | 32.1 | 0.6 | 1.8 | 0.0 | 0.1 | 0.1 | 0.5 | 0.2 | 0.7 | 0.0 | 0.0 | 0.6 | 2.0 |
| | | MP | 96/96 | 30.7 | 0.5 | 1.7 | 0.3 | 0.9 | 0.4 | 1.4 | 0.3 | 1.0 | 0.0 | 0.0 | 0.8 | 2.6 |
| GC2 | Swab | HN | 23/96 | 35.4 | 1.1 | 3.2 | 1.1 | 3.0 | 1.7 | 4.8 | 0.0 | 0.0 | 1.0 | 2.8 | 2.5 | 7.1 |
| | | LP | 95/96 | 31.1 | 0.7 | 2.2 | 0.3 | 0.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.6 | 0.8 | 2.4 |
| | | MP | 96/96 | 30.2 | 0.6 | 2.1 | 0.2 | 0.5 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.8 | 0.7 | 2.3 |
| GC2 | Urine | HN | 23/96 | 35.1 | 1.8 | 5.2 | 1.3 | 3.7 | 1.0 | 2.9 | 0.0 | 0.0 | 0.0 | 0.0 | 2.5 | 7.0 |
| | | LP | 92/96 | 31.1 | 0.8 | 2.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.8 | 2.7 |
| | | MP | 92/96 | 31.6 | 0.7 | 2.4 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.6 | 0.0 | 0.0 | 0.8 | 2.4 |
| | LBC a | HN | 10/96 | 36.0 | 1.1 | 3.0 | 0.0 | 0.0 | 1.2 | 3.3 | 0.0 | 0.0 | 1.1 | 3.0 | 1.9 | 5.3 |
| | | LP | 96/96 | 30.6 | 0.4 | 1.2 | 0.5 | 1.5 | 0.1 | 0.3 | 0.2 | 0.8 | 0.0 | 0.0 | 0.7 | 2.1 |
| | | MP | 96/96 | 29.4 | 0.4 | 1.5 | 0.3 | 1.1 | 0.3 | 1.2 | 0.3 | 1.0 | 0.0 | 0.0 | 0.7 | 2.4 |

Table 9: Neisseria gonorrhoeae Lot-to-Lot Quantitative Reproducibility Study Results

ª PreservCyt LBC

Table 10: Trichomonas vaginalis Lot-to-Lot Quantitative Reproducibility Study Results

| Matrix | Cat | Agree
/N | Mean | Within Run | | Between
Run | | Between
Day | | Between
Operator | | Between
Lot | | Total | |
|--------|-----|-------------|------|------------|-----|----------------|-----|----------------|-----|---------------------|-----|----------------|-----|-------|-----|
| Type | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Swab | HN | 39/96 | 36.8 | 2.1 | 5.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.3 | 0.7 | 0.0 | 0.0 | 2.1 | 5.8 |
| | LP | 95/96 | 33.4 | 1.2 | 3.7 | 0.0 | 0.0 | 0.3 | 0.9 | 0.0 | 0.0 | 0.3 | 1.0 | 1.3 | 4.0 |
| | MP | 96/96 | 32.4 | 0.7 | 2.3 | 0.1 | 0.4 | 0.1 | 0.3 | 0.1 | 0.2 | 0.0 | 0.0 | 0.8 | 2.4 |
| Urine | HN | 61/96 | 37.0 | 1.9 | 5.2 | 0.0 | 0.0 | 0.5 | 1.2 | 0.0 | 0.0 | 0.0 | 0.0 | 2.0 | 5.4 |
| | LP | 95/96 | 32.5 | 0.7 | 2.1 | 0.1 | 0.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.4 | 0.7 | 2.1 |
| | MP | 96/96 | 33.8 | 1.0 | 3.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.2 | 0.5 | 0.0 | 0.0 | 1.1 | 3.1 |

Sample Storage

Swab specimens must be transferred to a BD MAX Swab Sample Buffer Tube immediately after collection. First void urine specimens must be transferred from the collection cup to the BD MAX Urine Sample Buffer Tube immediately after collection. Once in the BD MAX Sample Buffer Tube, swab and urine specimens can be stored for up to 21 days at 2-30 ℃ and then up to an additional 30 days at -20 ℃ (Table 11).

14

Specimen Stability	Transport and/or Storage Time/Temperature
In BD MAX Swab or Urine
Sample Buffer Tube	Up to 21 days at 2-30 °C
and then up to an additional
30 days at -20 °C

LBC specimens in the vial prior to transfer to the BD MAX LBC Sample Buffer Tube can be stored up to 14 days at 2-30 ℃. Once in the BD MAX LBC Sample Buffer Tube, samples can be stored for up to 21 days at 2-30 °C and then up to an additional 30 days at -20 °C, prior to or after pre-warm (Table 12).

Specimen Stability	Transport and/or Storage Time/Temperature
Prior to transfer to BD MAX LBC Sample
Buffer Tube	Up to 14 days at 2-30 °C
In BD MAX LBC Sample Buffer Tube
(prior to or after pre-warm)	Up to 21 days at 2-30 °C
In BD MAX LBC Sample Buffer Tube
(after pre-warm)	and then up to an additional
30 days at -20 °C

Table 5: LBC Specimen Storage and Transport

Swab and Urine Specimen Storage and Transport

Controls

External Control materials are not provided by BD; however, Quality Control strains and procedures are included in the package insert. Various types of External Controls are recommended to allow the user to select the most appropriate for their laboratory quality control program:

Commercially available positive control materials:

Table 4:

Chlamydia trachomatis serovar H (ATCC VR-879)

Neisseria gonorrhoeae (ATCC 19424)

Trichomonas vaginalis (ATCC 30001)

External negative control

Use a non-inoculated BD MAX Swab Sample Buffer Tube

The assay includes a Specimen Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances.

Analytical Sensitivity

The analytical sensitivity/Limit of Detection (LoD) in urine, vaginal swab and PreservCyt LBC specimen matrix was determined by preparing microbial suspensions from each of two (2) representative strains of the target organisms inoculated into pooled female urine, pooled vaginal swab and pooled PreservCyt LBC matrix in sample buffer with multiple concentrations of each representative strain. Each matrix suspension was tested with at least 20 replicates per LoD concentration across 3 different reagent lots. Analytical sensitivity (LoD), defined as the lowest concentration at which at least 95% of all replicates tested positive, is represented in Table 13.

15

Organism	Strain	Specimen	LoD Concentration (units/mL)a
Chlamydia trachomatis	Serovar H	Urine	2.5
		Swab	2.5
		PreservCyt	5
Chlamydia trachomatis	Serovar D	Urine	1.25
		Swab	5
		PreservCyt	5
Neisseria gonorrhoeae	ATCC 19424	Urine	30
		Swab	15
		PreservCyt	30
Neisseria gonorrhoeae	ATCC 49226	Urine	15
		Swab	30
		PreservCyt	60
Trichomonas vaginalis	ATCC 30001	Urine	5
		Swab	7.5
Trichomonas vaginalis	ATCC 50143	Urine	2.5
		Swab	1.88

Table 6: BD MAX CTGCTV2 Limits of Detection

ª Units/mL LoD concentration represented in Elementary Bodies (EB)/mL for Chlamydia trachomatis, cells/mL for Neisseria gonorrhoeae and TV/mL for Trichomonas vaginalis.

Analytical Inclusivity

Inclusivity testing was performed for 13 additional Chlamydia trachomatis serovars, 30 additional Neisseria gonorrhoeae strains and 8 additional Trichomonas vaginalis strains by spiking into female urine, vaginal swab and PreservCyt LBC pools prepared in sample buffer at concentrations targeting the predetermined LoD for each organism. Each serovar/strain was tested in 20 replicates with at least three different reagent lots. The results for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are presented in Table 16 through Table 16 and show the concentrations which were detected in at least 19/20 replicates (≥95%).

		Swab		Urine		PreservCyt
Organism	Serovar	EBs/mL	% POS	EBs/mL	% POS	EBs/mL	% POS
Chalmydia
trachomatis	A	5	100	2.5	100	5	100
	B	5	100	2.5	100	5	100
	C	5	> 95	2.5	100	5	100
	E	5	100	2.5	100	5	100
	F	5	100	2.5	100	5	100
	G	5	100	2.5	100	5	100
	I	5	100	2.5	100	5	100
	J	5	100	2.5	100	5	100
	K	5	100	2.5	100	5	100
	LGV1	5	100	2.5	100	5	100
	LGV2	5	100	2.5	100	5	100
	LGV3	5	100	2.5	100	5	100
	vE	5	100	2.5	100	5	100

Table 7: Inclusivity Results – Chlamydia trachomatis

16

| Organism | Number
Strains | Swab | | Urine | | PreservCyt | |
|--------------------------|-------------------|----------|-------|----------|-------|------------|-------|
| | | Cells/mL | % POS | Cells/mL | % POS | Cells/mL | % POS |
| Neisseria
gonorrhoeae | 30 | NA | NA | NA | NA | 60 | ≥95 |
| | 27 | 30 | ≥95 | NA | NA | NA | NA |
| | 3 | 45 | ≥95 | NA | NA | NA | NA |
| | 29 | NA | NA | 30 | ≥95 | NA | NA |
| | 1 | NA | NA | 45 | 100 | NA | NA |

Table 8: Inclusivity Results – Neisseria gonorrhoeae

| Organism | ATCC
Strain | Swab | | Urine | |
|--------------------------|----------------|-------|-------|-------|-------|
| | | TV/mL | % POS | TV/mL | % POS |
| Trichomonas
vaginalis | 30092 | 7.5 | 100 | 5 | 100 |
| | 30184 | 7.5 | ≥ 95 | 5 | 100 |
| | 30185 | 7.5 | 100 | 5 | 100 |
| | 30186 | 7.5 | ≥ 95 | 5 | 100 |
| | 30235 | 7.5 | 100 | 5 | 100 |
| | 30236 | 7.5 | 100 | 5 | 100 |
| | 30238 | 7.5 | ≥ 95 | 5 | 100 |
| | 30240 | 7.5 | 100 | 5 | 100 |

Table 9: Inclusivity Results - Trichomonas vaginalis

Analytical Specificity

The BD MAX CTGCTV2 assay was performed on samples containing phylogenetically related microorganisms likely to be found in urogenital specimens (Table 17). The bacterial cells, yeasts, viruses and parasites were tested in the Sample Buffer Tube at 2x106 cells/mL, genomic DNA cp/mL, or EB/mL, and viruses were tested at 1x105 viral particles or genomic equivalents/mL.

98% of bacterial strains, yeasts, parasites and viruses tested produced negative results with the BD MAX CTGCTV2. Pentatrichomonas hominis (commensal of the large intestine) produced positive results at a concentration ≥ 1.00 x 105 TV/mL for Trichomonas vaginalis and negative results for all other targets with the BD MAX CTGCTV2 assay. Trichomonas tenax (commensal of the oral cavity) produced positive results at a concentration ≥ 1.88 TV/mL for Trichomonas vaginalis and negative results for all other targets with the BD MAX CTGCTV2 assay.

17

Organism	Organism	Organism
Achromobacter xerosis	Escherichia coli	Neisseria mucosa (3) a
Acinetobacter calcoaceticus	Escherichia vulneris	Neisseria perflava
Acinetobacter lwoffi	Fuseobacterium nucleatum	Neisseria polysaccharea
Actinomyces israelii	Gardnerella vaginalis	Neisseria sicca (3)
Actinomyces pyogenes	Gemella haemolysans	Neisseria subflava (14) a
Aerococcus viridans	Haemophilus ducreyi	Paracoccus denitrificans
Aeromonas hydrophilia	Haemophilus influenzae	Pentatrichomonas hominis
Agrobacterium radiobacter	Herpes Simplex Virus I	Peptostreptococcus anaerobius
Alcaligenes faecalis	Herpes Simplex Virus II	Peptostreptococcus productus
Atopobium vaginae	HIV 1	Plesiomonas shigelloides
Bacillus subtilis	HPV 16	Prevotella bivia
Bacteroides fragilis	Kingella dentrificans	Propionibacterium acnes
Bacteroides ureoeolyticus	Kingella kingae	Proteus mirabilis
Bifidobacterium adolescentis	Klebsiella oxytoca	Proteus vulgaris
Bifidobacterium brevi	Klebsiella pneumoniae	Providencia stuartii
Blastocystis hominis	Lactobacillus acidophilus	Pseudomonas aeruginosa
Branhamella catarrhalis	Lactobacillus brevis	Pseudomonas fluorescens
Brevibacterium linens	Lactobacillus jensenii	Pseudomonas putida
Campylobacter jejuni	Lactobacillus lactis	Rahnella aquatilis
Candida albicans	Lactobacillus vaginalis	Rhodospirilium rubrum
Candida gabralta	Legionella pneumophilia (2) a	Saccharomyces cerevisiae
Candida parapsilosis	Leuconostoc paramensenteroides	Salmonella minnesota
Candida tropicalis	Listeria monocytogenes	Salmonella typhimurium
Chlamydiophila pneumoniae	Micrococcus leutus	Serratia marcescens
Chlamydiophila psittaci (2) a	Mobiluncus curtisii	Staphylococcus aureus,non-protein
Chromobacterium violaceum	Moraxella lacunata	Staphylococcus aureus, protein-A
Citrobacter freundii	Moraxella osloensis	Staphylococcus epidermidis
Clostridium difficile	Morganella morganii	Staphylococcus saprophyticus
Clostridium perfringens	Mycobacterium smegmatis	Streptococcus bovis
Corynebacterium genitalium biovar1	Mycoplasma genitalium	Streptococcus agalactiae (Group B)
Corynebacterium xerosis	Mycoplasma hominis	Streptococcus mitis
Cryptococcus neoformans	Neisseria cinerea (4)a	Streptococcus mutans
Cytomegalovirus	Neisseria denitrificans	Streptococcus pneumoniae
Deinococcus radiodurans	Neisseria elongate (3) a	Streptococcus pyogenes (Group A)
Derxia gummosa	Neisseria flava	Streptococcus salivarius
Eikenella corrodens	Neisseria flavescens (2) a	Streptococcus sanguis
Elizabethkingia meningosepticum	Neisseria lactamica (9) a	Streptomyces griseinus
Enterobacter aerogenes	Neisseria meningitidis A	Trichomonas tenax
Enterobacter cloacae	Neisseria meningitidis B	Ureaplasma urealyticum
Enterococcus avium	Neisseria meningitidis C (4) a	Vibrio parahaemolyticus
Enterococcus faecalis	Neisseria meningitidis D	Yersinia enterocolitica
Enterococcus faecium	Neisseria meningitidis W135
Erysipelothrix rhusiopathiae	Neisseria meningitidis Y

Table 17: Specificity Organisms (Bacteria, Yeasts, Parasites and Viruses)

a The number in parenthesis indicates the number of strains tested.

Interfering Substances

Forty-four (44) biological and chemical substances that may be present in urogenital specimens were evaluated for potential interference at concentrations that may be found in urogenital specimens.

18

Negative urine, vaginal swab and PreservCyt LBC pooled specimens and a target mix of Chlamydia trachomatis. Neisseria gonorrhoeae and Trichomonas vaginalis positive at 3X LoD were tested with each substance. Potentially interfering substances in urine specimens include whole blood. Potentially interfering substances in vaginal swab specimens include VCF Contraceptive Foam and Film, Conceptrol Contraceptive Gel, Monistat 3 cream, Vaginal Anti-Itch Cream, McKesson Lubricating Jelly, Surgilube, Aquagel, Acyclovir, Metronidazole, Replens, mucous and whole blood. Potentially interfering substances in PreservCyt LBC specimens include Vaginal Anti-Itch Cream, Metronidazole Gel, Replens, mucous, whole blood, McKesson Lubricating Jelly, Surgilube and Aquagel. The following substances shown in Table 18 through Table 20 did not cause interference with the BD MAX CTGCTV2 assays at the concentrations shown below.

Substance	Concentration
Norethindrone	16 ng/mL
17-α-Ethinylestradiol	0.96 ng/mL
4-Acetamidophenol	160 µg/mL
Acetylsalicylic Acid	521.6 µg/mL
Naproxen	400 µg/mL
Ibuprofen	400 µg/mL
Human Serum Albumin	0.8 mg/mL
Glucose	0.96 mg/mL
Amoxicillin Trihydrate	60.16 µg/mL
Metronidazole	96 µg/mL
Tetracycline Hydrochloride	12 µg/mL
Azithromycin	9.6 µg/mL
Ceftriaxone	648.8 µg/mL
Sulfamethoxazole	320 µg/mL
Trimethoprim	32 µg/mL
Erythromycin	48 µg/mL
Mucous (Bovine Cervical)	4% v/v
Whole Blood	0.6% v/v a
Semen	4% v/v
Leukocytes	2x106 cells/mL
Phenazopyridine Hydrochloride	160 µg/mL
High pH (NaOH)	pH 9
Low pH (HCl)	pH 4
Bilirubin	0.16 mg/mL
Feminine Deodorant Spray	0.68% v/v
Talcum Powder	2.64% v/v

Table 108:	Endogenous and Exogenous Substances Tested for Interference in Urine

a May interfere with the BD MAX CTGCTV2 assay when at concentrations higher than shown.

19

Substance	Concentration
VCF Contraceptive Foam	15 µL/mLa
VCF Contraceptive Film	0.5 µL/mLa
Conceptrol Contraceptive Gel	3 µL/mLa
Gyne-Lotrimin 3	50 µL/mL
Monistat 3 Cream	0.1 µL/mLa
Tioconazole 1	50 µL/mL
Vaginal Anti-Itch Cream	0.1 µL/mLa
Vaginal Lubricant Liquid - water based	50 µL/mL
Preparation H Hemorrhoid Gel	50 µL/mL
Antiviral (Zovirax – Acyclovir)	0.01 µL/mLa
Metronidazole Gel (AntiProtozoal)	1.25 µL/mLa
Replens (Vaginal Moisturizer)	0.1 µL/mLa
Douche	50 µL/mL
Feminine Deodorant Spray	50 µL/mL
Progesterone	20 ng/mL
Estradiol	1.2 ng/mL
Mucous (Bovine Cervical)	4.5% v/va
Semen	5% v/v
Whole Blood	8 µL/mLa
Leukocytes	1x106 cells/mL
Aquagel	0.0345 mg/mLa
McKesson Lubricating Jelly	0.445 mg/mLa
Surgilube	0.41 mg/mLa
KY Lubricating Jelly	137.5 mg/mL

Table 19: Endogenous and Exogenous Substances Tested for Interference in Swab Specimens

ª May interfere with the BD MAX CTGCTV2 assay when at concentrations higher than shown.

20

Substance	Concentration
Vaginal Lubricant	2% v/v
Douche	2% v/v
Vaginal Deodorant Spray	2% v/v
Progesterone	20 ng/mL
Estradiol	1.2 ng/mL
Leukocytes	1 x 106 cells/mL
Semen	2% v/v
Monistat 3	2% v/v
Clotrimazole 7	2% v/v
Tioconazole 1	2% v/v
Vaginal contraceptive film	2% v/v
Vaginal contraceptive foam	2% v/v
Contraceptive gel	2% v/v
Vaginal anti-itch Cream	1% v/va
Zovirax (Acyclovir) Cream	2% v/v
Metronidazole Gel 0.75%	0.01% v/va
Replens (Vaginal Moisturizer)	0.1% v/va
Mucous (Bovine Cervical)	1.9% v/va
Whole Blood	0.5% v/va
Aquagel	0.276 mg/mLa
McKesson Lubricating Jelly	3.56 mg/mLa
Surgilube	328 mg/mLa
KY Lubricating Jelly	1.100 mg/mLa

Table 20: Endogenous and Exogenous Substances Tested for Interference in PreservCyt LBC Specimens

a May interfere with the BD MAX CTGCTV2 assay when at concentrations higher than shown.

Carryover/Cross-Contamination

High positive samples containing Chlamydia trachomatis (VR-879, Serovar H) spiked into pooled PreservCyt LBC matrix at a concentration of >1 x 10 EB/mL were processed with negative samples consisting of LBC Sample Buffer Tubes without any target analyte. Twelve (12) replicates of the high positive panel member and 12 replicates of the negative panel member were tested in 18 runs by alternating negative and positive samples, using three BD MAX instruments for a total of 216 positive and 216 negative samples tested. Of the 216 negative samples tested, two false positive results were obtained (0.93%, 95% CI: 0.25% - 3.31%).

Mixed Infection/Competitive Interference

Three test samples prepared in pooled clinical matrix (swab, urine and PreservCyt LBC) each containing one of the target organisms (Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis) at 1.5X their respective LoD, were tested with a high target mix comprised of the other two BD MAX CTGCTV2 analytes at a concentration ≥ 1x10 EB, cells or TV/mL to simulate mixed infections. The samples were tested in 20 replicates. All three low target organisms were successfully detected at ≥95% by the BD MAX CTGCTV2 assay in the presence of the other two organisms at high concentrations in urine, vaginal swab and PreservCyt LBC specimens. When assessed across all organisms and sample types, the observed Ct score shift ranged from -0.1 to 4.5 for Chlamydia

21

trachomatis, from -1.8 to 5.8 for Neisseria gonorrhoeae, and from 1.0 to 4.8 for Trichomonas vaginalis.

Clinical Performance Studies

Twelve geographically diverse clinical sites in North America participated in the clinical trial to evaluate the BD MAX CTGCTV2 assay. Two thousand five hundred and forty-seven (2,547) female subjects and 1.159 male subjects representing ages 18 and over were enrolled from sexually transmitted disease (STD). OB/GYN, and family planning clinics. Subjects were classified as symptomatic if they reported symptoms such as dysuria, urethral discharge, itching, odor, coital pain/difficulty/bleeding, testicular or scrotum pain/swelling, abnormal vaginal discharge, or pelvic/ uterine/adnexal pain. Subjects were classified as asymptomatic if they did not report these symptoms.

Eight specimens were collected from each eligible female subject: one first-catch urine, two randomized patient-collected vaginal swab specimens, two randomized clinician-collected vaginal swab specimens, two randomized endocervical swab specimens and one PreservCyt LBC specimen (collected using either the cervical broom or brush/spatula). One urine specimen was collected from each of the eligible male subjects. Samples were prepared for BD MAX CTGCTV2 and reference testing in accordance with the appropriate specimen collection kit package insert instructions.

All specimens from enrolled subjects were tested across five clinical trial testing sites. Samples with initial non-reportable (Unresolved, Indeterminate or Incomplete) results were repeated from the BD MAX Sample Buffer Tube. Following a valid repeat test, 0.3% (38/13,649) specimens remained nonreportable and were excluded from the sensitivity and specificity statistical analysis. The final data analysis included 2,536 evaluable female subjects and 1,149 evaluable male subjects. The estimates of performance of the BD MAX CTGCTV2 assay for Chlamydia trachomatis included: 2,508 patientcollected vaginal swabs, 2,502 clinician-collected vaginal swabs, 2,512 endocervical swabs, 2,469 PreservCyt LBC, 2,416 female urine and 1,140 male urine specimens. The estimates of performance of the BD MAX CTGCTV2 assay for Neisseria gonorrhoeae included: 2.506 patient-collected vaginal swabs, 2,503 clinician-collected vaginal swabs, 2,511 endocervical swabs, 2,470 PreservCyt LBC, 2,419 female urine and 1,142 male urine specimens. The estimates of performance of the BD MAX CTGCTV2 assay for Trichomonas vaginalis included: 1,742 patient-collected vaginal swabs, 1,732 cliniciancollected vaginal swabs, 1,646 female urine and 1,141 male urine specimens. Exclusions included but were not limited to: missing specimens and/or reference test results, transport, collection, shipping, and/or processing errors.

Clinical Performance of Chlamydia trachomatis and Neisseria gonorrhoeae

The clinical performance of the BD MAX CTGCTV2 for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in females and males was calculated compared to a Patient Infected Status (PIS). The female PIS was established by testing urine and cervical specimens with two different FDA cleared NAATs (Nucleic Acid Amplification Test) where female subjects were designated as infected if at least two different reference NAATs were positive for urine and cervical specimens. For the purpose of data analysis, females who tested positive with the two comparator NAATs in urine only (negative in swabs with both NAATs), were considered non-infected when calculating the performance of the assay for swab specimens. The male PIS was established by testing urine specimens using up to three different FDA cleared NAATs where male subjects were designated as infected if 2 out of 3 reference NAAT results were positive. Subjects were categorized as non-infected if 2 out of 3 reference NAAT results were negative. The resulting performance is shown in Table 21.

22

| Gender | Specimen
Type | Symptom
status | Chlamydia trachomatis | | Neisseria gonorrhoeae | | Gender | Specimen Type | Symptom
status | Trichomonas vaginalis | |
|--------|----------------------|-------------------|------------------------------|----------------------------------|------------------------------|----------------------------------|--------|-------------------|-------------------|------------------------------|----------------------------------|
| | | | % Sens | % Spec | % Sens | % Spec | | | | % Sens | % Spec |
| Female | Vaginal
Clinician | A | 98.2
55/56
90.6-99.7 | 98.8
1,076/1,089
98-99.3 | 100
15/15
79.6-100 | 99.8
1,129/1,131
99.4-100 | Female | Vaginal Clinician | A | 98.5
66/67
92.0-99.7 | 99.6
687/690
98.7-99.9 |
| | | S | 98.6
71/72
92.5-99.8 | 99.0
1,272/1,285
98.3-99.4 | 96.4
27/28
82.3-99.4 | 99.9
1,328/1,329
99.6-100 | | | S | 97.5
116/119
92.8-99.1 | 99.6
853/856
99.0-99.9 |
| | | All | 98.4
126/128
94.5-99.6 | 98.9
2,348/2,374
98.4-99.3 | 97.7
42/43
87.9-99.6 | 99.9
2,457/2,460
99.6-100 | | | All | 97.8
182/186
94.6-99.2 | 99.6
1540/1546
99.2-99.8 |
| | Vaginal Self | A | 98.2
55/56
90.6-99.7 | 98.9
1,077/1,089
98.1-99.4 | 100
15/15
79.6-100 | 99.6
1,126/1,130
99.1-99.9 | | Vaginal Self | A | 97.0
65/67
89.8-99.2 | 99.1
685/691
98.1-99.6 |
| | | S | 98.6
71/72
92.5-99.8 | 98.5
1,271/1,291
97.6-99 | 100
28/28
87.9-100 | 100
1,333/1,333
99.7-100 | | | S | 98.4
120/122
94.2-99.5 | 99.2
855/862
98.3-99.6 |
| | | All | 98.4
126/128
94.5-99.6 | 98.7
2,348/2,380
98.1-99 | 100
43/43
91.8-100 | 99.8
2,459/2,463
99.6-99.9 | | | All | 97.9
185/189
94.7-99.2 | 99.2
1540/1553
98.6-99.5 |
| | Endo-
cervical | A | 96.4
54/56
87.9-99 | 99.4
1,084/1,090
98.8-99.7 | 100
15/15
79.6-100 | 99.9
1,131/1,132
99.5-100 | | | A | 96.2
25/26
81.1-99.3 | 99.6
678/681
98.7-99.9 |
| | | S | 93.1
67/72
84.8-97 | 99.1
1,282/1,294
98.4-99.5 | 92.9
26/28
77.4-98 | 100
1,336/1,336
99.7-100 | | | S | | |
| | | All | 94.5
121/128
89.1-97.3 | 99.2
2,366/2,384
98.8-99.5 | 95.3
41/43
84.5-98.7 | 100
2,467/2,468
99.8-100 | | | All | | |
| | LBC
Preserv-Cyt | A | 92.6
50/54
82.4-97.1 | 99.7
1,076/1,079
99.2-99.9 | 100
15/15
79.6-100 | 99.9
1,118/1,119
99.5-100 | Male | Urine | A | 96.2
25/26
81.1-99.3 | 99.6
678/681
98.7-99.9 |
| | | S | 92.9
65/70
84.3-96.9 | 99.8
1,264/1,266
99.4-100 | 88.9
24/27
71.9-96.1 | 100
1,309/1,309
99.7-100 | | | S | 100
22/22
85.1-100 | 100
412/412
99.1-100 |
| | | All | 92.7
115/124
86.8-96.1 | 99.8
2,340/2,345
99.5-99.9 | 92.9
39/42
81-97.5 | 100
2,427/2,428
99.8-100 | | | All | 97.9
47/48
89.1-99.6 | 99.7
1,090/1,093
99.2-99.9 |
| Male | Urine | A | 97.3
71/73
90.5-99.2 | 99.6
667/670
98.7-99.8 | 100
12/12
75.8-100 | 100
732/732
99.5-100 | | | | | |
| | | S | 96.3
77/80
89.5-98.7 | 99.1
314/317
97.3-99.7 | 99.1
110/111
95.1-99.8 | 99.7
286/287
98.1-99.9 | | | | | |
| | | All | 96.7
148/153
92.6-98.6 | 99.4
981/987
98.7-99.7 | 99.2
122/123
95.5-99.9 | 99.9
1,018/1,019
99.4-100 | | | | | |

Table 21: Chlamydia trachomatis and Neisseria gonorrhoeae Performance Compared to PIS

23

Clinical Performance of Trichomonas vaginalis

The clinical performance of the BD MAX CTGCTV2 for the detection of Trichomonas vaginalis infection in females and males was calculated compared to a PIS. The female PIS was established by testing vaginal specimens with two different FDA cleared molecular tests, across three different instrument platforms, where female subjects were designated as infected if 2 out of 3 reference test results were positive. Subjects were categorized as non-infected if 2 out of 3 reference test results were negative. The male PIS was established by testing urine specimens using up to three different FDA cleared NAATs where male subjects were designated as infected if 2 out of 3 reference test results were positive. Subjects were categorized as non-infected if 2 out of 3 reference test results were negative. The resulting performance is shown in Table 22.

Table 22: Trichomonas vaginalis Performance Compared to the PIS

Clinical Performance of Female Urine

The clinical performance of the BD MAX CTGCTV2 for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis infection in female urine was calculated compared to a Composite Comparator Algorithm (CCA) utilizing urine samples from up to three reference NAATs to generate reference results for each analyte. Female subjects were designated as positive if 2 out of 3 reference NAAT results were positive. Subjects were categorized as negative if 2 out

24

of 3 reference NAAT results were negative. The resulting performance expressed as positive percent agreement (PPA) and negative percent agreement (NPA) is shown in Table 23.

Additionally, the results obtained when using urine specimens in females were evaluated against the PIS based on cervical and urine algorithm. In the clinical study conducted for the BD MAX CTGCTV2 assay, female urine detected 5.8% fewer Chlamydia trachomatis infections than clinician and self-collected vaginal swabs and 1.9% fewer Chlamydia trachomatis infections than endocervical swabs. Female urine detected 2.4% fewer Neisseria gonorrhoeae infections than clinician-collected vaginal swabs and 4.7% fewer Neisseria gonorrhoeae infections than patientcollected vaginal swabs. There was no difference in the detection of Neisseria gonorrhoeae infections when comparing female urine and endocervical swabs.

| Specimen
Type | Symp.
Status | Chlamydia trachomatis | | Neisseria gonorrhoeae | | Trichomonas vaginalis | |
|------------------|-----------------|------------------------------|----------------------------------|--------------------------|---------------------------------|----------------------------|----------------------------------|
| | | PPA | NPA | PPA | NPA | PPA | NPA |
| Female Urine | A | 98.1
51/52
89.9-99.7 | 99.2
1,037/1,045
98.5-99.6 | 100
14/14
78.5-100 | 99.9
1,085/1,086
99.5-100 | 100
58/58
93.8-100 | 99.8
646/647
99.1-100 |
| | S | 98.6
70/71
92.4-99.8 | 99.4
1,241/1,248
98.8-99.7 | 100
25/25
86.7-100 | 100
1,294/1,294
99.7-100 | 100
115/115
96.8-100 | 99.4
821/826
98.6-99.7 |
| | All | 98.4
121/123
94.3-99.6 | 99.3
2,278/2,293
98.9-99.6 | 100
39/39
91.0-100 | 100
2,379/2,380
99.8-100 | 100
173/173
97.8-100 | 99.6
1,467/1,473
99.1-99.8 |

Table 23: Clinical Performance of BD MAX CTGCTV2 in Female Urine, Compared to the CCA

Of all the specimens initially evaluated with the BD MAX CTGCTV2 assay, 1.1% of vaginal clinician-collected, 1.3% of patient-collected vaginal swab, 0.9% of endocervical swab, 0.2% of PreservCyt LBC and 0.9% of urine specimens initially reported as Unresolved. Following a valid repeat test, 0.3% of clinician-collected vaginal swab, 0.4% of patient-collected vaginal swab, 0.1% of endocervical swab, 0.0% of PreservCyt LBC and 0.1% of urine specimens remained Unresolved. The total numbers in Table 24 are based on compliant specimens and BD MAX CTGCTV2 results.

	Initial Unresolved Rate		Final Unresolved Rate with Valid Repea
Specimen Type	Percent	95% CI	Percent	95% CI
Vaginal Clinician-Collected	1.1% (28/2,517)	(0.8%, 1.6%)	0.3% (7/2,517)	(0.1%, 0.6%)
Vaginal Patient-Collected	1.3% (34/2,525)	(1.0%, 1.9%)	0.4% (10/2,525)	(0.2%, 0.7%)
Endocervical	0.9% (22/2,519)	(0.6%, 1.3%)	0.1% (3/2,516)	(0.0%, 0.3%)
LBC PreservCyt	0.2% (6/2,473)	(0.1%, 0.5%)	0.0% (0/2,471)	(0.0%, 0.2%)
Urine	0.9% (34/3,621)	(0.7%, 1.3%)	0.1% (3/3,620)	(0.0%, 0.2%)

Table 24:	Unresolved Rates
-----------	------------------

I

Of all the specimens initially evaluated with the BD MAX CTGCTV2 assay, 0.7% of cliniciancollected vaginal swab, 0.6% of patient-collected vaginal swab, 0.6% of endocervical swab, 1.2% of PreservCyt LBC and 1.2% of urine specimens initially reported as Incomplete. Following a valid repeat test, 0.0% of all specimen types remained Incomplete. The total numbers in Table 25 are based on compliant specimens and BD MAX CTGCTV2 results.

25

| Specimen Type | Initial Indeterminate Rate
Percent | 95% CI | Final Indeterminate Rate with Valid Repeat
Percent | 95% CI |
|-----------------------------|---------------------------------------|--------------|-------------------------------------------------------|--------------|
| Vaginal Clinician-Collected | 0.8% (20/2,517) | (0.5%, 1.2%) | 0.2% (6/2,517) | (0.1%, 0.5%) |
| Vaginal Patient-Collected | 0.9% (23/2,525) | (0.6%, 1.4%) | 0.1% (3/2,525) | (0.0%, 0.3%) |
| Endocervical | 0.8% (19/2,519) | (0.5%, 1.2%) | 0.1% (2/2,516) | (0.0%, 0.3%) |
| LBC PreservCyt | 0.2% (6/2,473) | (0.1%, 0.5%) | 0.0% (0/2,471) | (0.0%, 0.2%) |
| Urine | 0.2% (9/3,621) | (0.1%, 0.5%) | 0.1% (3/3,620) | (0.0%, 0.2%) |

Table 25: Indeterminate Rates

Of all the specimens initially evaluated with the BD MAX CTGCTV2 assay, 0.7% of cliniciancollected vaginal swab, 0.6% of patient-collected vaginal swab, 0.6% of endocervical swab, 1.2% of PreservCyt LBC and 1.2% of urine specimens initially reported as Incomplete. Following a valid repeat test, 0.0% of all specimen types remained Incomplete. The total numbers in Table 26 are based on compliant specimens and BD MAX CTGCTV2 results.

	Initial Incomplete Rate		Final Incomplete Rate with Valid Repeat
Specimen Type	Percent	95% CI	Percent	95% CI
Vaginal Clinician-Collected	0.7% (17/2,517)	(0.4%, 1.1%)	0.0% (0/2,517)	(0.0%, 0.2%)
Vaginal Patient-Collected	0.6% (14/2,525)	(0.3%, 0.9%)	0.0% (1/2,525)	(0.0%, 0.2%)
Endocervical	0.6% (14/2,519)	(0.3%, 0.9%)	0.0% (0/2,516)	(0.0%, 0.2%)
LBC PreservCyt	1.2% (30/2,473)	(0.9%, 1.7%)	0.0% (0/2,471)	(0.0%, 0.2%)
Urine	1.2% (45/3,621)	(0.9%, 1.7%)	0.0% (0/3,620)	(0.0%, 0.1%)

Table 26: Incomplete Rates

Expected Values

The positivity rate of the MAX CTGCTV2, as observed during the multi-center clinical study, is shown by specimen type in Table 27 and Table 28.

BD MAX CTGCTV2 Clinical Study Female Positivity Table 117:

% Positive (No. positive/No. of valid results)
Site	Chlamydia trachomatis					Neisseria gonorrhoeae					Trichomonas vaginalis
	CCVSa	SCVSb	Endo	LBCc	Urine	CCVSa	SCVSb	Endo	LBCc	Urine	CCVSa	SCVSb	Urine
1	3.4%
10/294	3.4%
10/297	3.3%
10/299	2.7%
8/298	3.1%
9/295	0.3%
1/294	0.7%
2/297	0.3%
1/299	0.3%
1/298	0.3%
1/295	23.1%
68/295	23.7%
71/299	23.4%
69/295
2	3.7%
18/486	5.1%
25/490	4.7%
23/489	3.8%
18/471	4.7%
23/489	1.0%
5/486	0.8%
4/489	0.6%
3/489	0.4%
2/471	0.8%
4/489	10.7%
52/486	12.0%
59/490	11.6%
57/491
3	5.3%
7/132	6.0%
8/133	4.5%
6/132	3.8%
5/133	4.5%
6/134	2.3%
3/132	2.3%
3/133	2.3%
3/132	2.3%
3/133	2.2%
3/134	6.8%
9/132	7.5%
10/133	7.5%
10/134
4	17.2%
5/29	17.2%
5/29	17.2%
5/29	13.8%
4/29	10.3%
3/29	3.4%
1/29	3.4%
1/29	3.4%
1/29	3.4%
1/29	3.4%
1/29	20.7%
6/29	20.7%
6/29	20.7%
6/29
5	7.1%
13/182	7.1%
13/182	5.5%
10/182	6.0%
11/182	7.7%
14/182	3.3%
6/182	3.3%
6/182	2.7%
5/182	2.7%
5/182	2.7%
5/182	14.8%
27/182	14.3%
26/182	14.3%
26/182
6	7.3%
35/482	7.0%
34/483	5.4%
26/481	5.2%
25/484	6.2%
28/453	1.5%
7/482	1.7%
8/482	1.5%
7/481	1.2%
6/484	1.5%
7/453	6.6%
32/482	7.9%
38/482	6.6%
30/453
7	6.7%
5/75	6.7%
5/75	7.9%
6/76	6.4%
5/78	7.9%
6/76	0.0%
0/75	0.0%
0/75	0.0%
0/76	0.0%
0/78	0.0%
0/76	10.7%
8/75	12.0%
9/75	11.8%
9/76
8	3.9%
11/283	4.6%
13/283	3.9%
11/282	3.6%
10/276	3.7%
10/272	0.0%
0/283	0.0%
0/282	0.0%
0/282	0.0%
0/276	0.0%
0/272	1.4%
4/283	1.1%
3/282	1.1%
3/272
9	12.8%
33/257	11.6%
30/259	11.2%
29/259	10.6%
25/235	10.9%
28/256	6.2%
16/257	6.6%
17/259	6.2%
16/257	6.8%
16/235	5.5%
14/256	18.7%
48/257	18.1%
47/259	16.8%
43/256
10	9.4%
12/127	11.0%
14/127	10.2%
13/127	7.9%
10/127	7.9%
10/127	4.7%
6/127	4.7%
6/127	4.7%
6/127	4.7%
6/127	4.7%
6/127	7.9%
10/127	7.9%
10/127	7.9%
10/127
11	2.5%
4/157	1.9%
3/156	0.6%
1/157	0.0%
0/157	1.9%
3/157	0.0%
0/157	0.0%
0/156	0.0%
0/157	0.0%
0/157	0.0%
0/157	1.3%
2/157	1.3%
2/156	1.3%
2/157
Total	6.1%
153/2504	6.4%
160/2514	5.6%
140/2513	4.9%
121/2470	5.7%
140/2470	1.8%
45/2504	1.9%
47/2511	1.7%
42/2511	1.6%
40/2470	1.7%
41/2470	10.6%
266/2505	11.2%
281/2514	10.7%
265/2472

ª Clinician-collected vaginal swab

b Self-collected vaginal swab

26

% Positive (No. positive/No. of valid results)
Site	Chlamydia trachomatis	Neisseria gonorrhoeae	Trichomonas vaginalis
1	17.0%
8/47	2.1%
1/47	0.0%
0/47
2	18.9%
28/148	23.6%
35/148	2.0%
3/148
3	12.0%
35/291	9.6%
28/291	5.2%
15/291
4	10.0%
36/359	7.2%
26/359	3.3%
12/359
5	13.3%
13/98	4.1%
4/98	5.1%
5/98
6	17.6%
35/199	14.6%
29/199	7.5%
15/199
Total	13.6%
155/1,142	10.8%
123/1,142	4.4%
50/1,142

Table 128: BD MAX CTGCTV2 Clinical Study Male Positivity

Positive and Negative Predictive Value

Hypothetical Positive Predictive Value (PPV) and Negative Predictive Value (NPV) based on observed sensitivity and specificity as compared to the Patient Infected Status are shown in Table 29.

27

| Specimen
Type | Hypothetical
Prevalence | Chlamydia trachomatis | | Neisseria gonorrhoeae | | Trichomonas vaginalis | |
|-------------------|----------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|-------------------------|
| | | % PPV
95% CI | % NPV
95% CI | % PPV
95% CI | % NPV
95% CI | % PPV
95% CI | % NPV
95% CI |
| Vaginala | 1% | 44.9%
(36.3%, 53.9%) | 100%
(99.9%, 100%) | 87.5%
(73.8%, 96.1%) | 100%
(99.9%, 100%) | 61.7%
(47.3%, 76.4%) | 100%
(99.9%, 100%) |
| | 2% | 62.2%
(53.5%, 70.3%) | 100%
(99.9%, 100%) | 93.4%
(85.1%, 98.0%) | 100%
(99.8%, 100%) | 76.5%
(64.5%, 86.7%) | 100%
(99.9%, 100%) |
| | 5% | 80.9%
(74.8%, 85.9%) | 99.9%
(99.7%, 100%) | 97.3%
(93.6%, 99.2%) | 99.9%
(99.6%, 100%) | 89.4%
(82.4%, 94.4%) | 99.9%
(99.7%, 100%) |
| | 10% | 90.0%
(86.2%, 92.8%) | 99.8%
(99.4%, 100%) | 98.7%
(96.9%, 99.6%) | 99.9%
(99.1%, 100%) | 94.7%
(90.8%, 97.3%) | 99.8%
(99.4%, 99.9%) |
| | 15% | 93.4%
(90.9%, 95.3%) | 99.7%
(99.0%, 99.9%) | 99.2%
(98.0%, 99.8%) | 99.8%
(98.5%, 100%) | 96.6%
(94.0%, 98.3%) | 99.6%
(99.1%, 99.9%) |
| | 20% | 95.3%
(93.4%, 96.7%) | 99.6%
(98.6%, 99.9%) | 99.4%
(98.6%, 99.8%) | 99.7%
(97.9%, 100%) | 97.6%
(95.7%, 98.8%) | 99.5%
(98.7%, 99.8%) |
| | 25% | 96.4%
(94.9%, 97.5%) | 99.5%
(98.2%, 99.9%) | 99.6%
(98.9%, 99.9%) | 99.6%
(97.3%, 100%) | 98.2%
(96.7%, 99.1%) | 99.3%
(98.2%, 99.7%) |
| Endocervical | 1% | 55.8%
(44.5%, 66.7%) | 99.9%
(99.9%, 100%) | 96.0%
(80.8%, 99.3%) | 100%
(99.8%, 100%) | | |
| | 2% | 71.9%
(61.8%, 80.2%) | 99.9%
(99.8%, 99.9%) | 98.0%
(89.5%, 99.6%) | 99.9%
(99.7%, 100%) | | |
| | 5% | 86.8%
(80.7%, 91.2%) | 99.7%
(99.4%, 99.9%) | 99.2%
(95.6%, 99.9%) | 99.8%
(99.2%, 99.9%) | | |
| | 10% | 93.3%
(89.8%, 95.7%) | 99.4%
(98.8%, 99.7%) | 99.6%
(97.9%, 99.9%) | 99.5%
(98.3%, 99.9%) | | |
| | 15% | 95.7%
(93.3%, 97.2%) | 99.0%
(98.1%, 99.5%) | 99.8%
(98.7%, 100%) | 99.2%
(97.3%, 99.8%) | | |
| | 20% | 96.9%
(95.2%, 98.0%) | 98.6%
(97.3%, 99.3%) | 99.8%
(99.0%, 100%) | 98.9%
(96.3%, 99.7%) | | |
| | 25% | 97.7%
(96.4%, 98.5%) | 98.2%
(96.5%, 99.1%) | 99.9%
(99.3%, 100%) | 98.5%
(95.1%, 99.6%) | | |
| LBC
PreservCyt | 1% | 81.5%
(65.2%, 91.1%) | 99.9%
(99.9%, 100%) | 95.8%
(80.1%, 99.2%) | 99.9%
(99.8%, 100%) | | |
| | 2% | 89.9%
(79.1%, 95.4%) | 99.9%
(99.7%, 99.9%) | 97.9%
(89.0%, 99.6%) | 99.9%
(99.6%, 99.9%) | | |
| | 5% | 95.8%
(90.7%, 98.2%) | 99.6%
(99.3%, 99.8%) | 99.2%
(95.4%, 99.9%) | 99.6%
(99.0%, 99.9%) | | |
| | 10% | 98.0%
(95.4%, 99.1%) | 99.2%
(98.5%, 99.6%) | 99.6%
(97.8%, 99.9%) | 99.2%
(97.9%, 99.7%) | | |
| | 15% | 98.7%
(97.0%, 99.4%) | 98.7%
(97.7%, 99.3%) | 99.7%
(98.6%, 100%) | 98.8%
(96.8%, 99.6%) | | |
| | 20% | 99.1%
(97.9%, 99.6%) | 98.2%
(96.8%, 99.0%) | 99.8%
(99.0%, 100%) | 98.2%
(95.5%, 99.4%) | | |
| | 25% | 99.3%
(98.4%, 99.7%) | 97.6%
(95.8%, 98.7%) | 99.9%
(99.3%, 100%) | 97.7%
(94.0%, 99.2%) | | |
| Urine | 1% | 61.6%
(42.5%, 77.8%) | 100%
(99.9%, 100%) | 91.1%
(64.4%, 98.3%) | 100%
(100%, 100%) | 78.3%
(55.1%, 91.4%) | 100%
(99.9%, 100%) |
| | 2% | 76.5%
(59.9%, 87.6%) | 99.9%
(99.8%, 100%) | 95.4%
(78.5%, 99.2%) | 100.0%
(99.9%, 100%) | 87.9%
(71.3%, 95.5%) | 100%
(99.8%, 100%) |
| | 5% | 89.3%
(79.4%, 94.8%) | 99.8%
(99.6%, 99.9%) | 98.2%
(90.4%, 99.7%) | 100%
(99.8%, 100%) | 94.9%
(86.5%, 98.2%) | 99.9%
(99.4%, 100%) |
| | 10% | 94.6%
(89.1%, 97.5%) | 99.6%
(99.2%, 99.8%) | 99.1%
(95.2%, 99.8%) | 99.9%
(99.5%, 100%) | 97.5%
(93.1%, 99.1%) | 99.8%
(98.8%, 100%) |
| | 15% | 96.6%
(92.8%, 98.4%) | 99.4%
(98.7%, 99.8%) | 99.4%
(96.9%, 99.9%) | 99.9%
(99.2%, 100%) | 98.4%
(95.5%, 99.5%) | 99.6%
(98.1%, 99.9%) |
| | 20% | 97.5%
(94.8%, 98.9%) | 99.2%
(98.2%, 99.6%) | 99.6%
(97.8%, 99.9%) | 99.8%
(98.9%, 100%) | 98.9%
(96.8%, 99.6%) | 99.5%
(97.3%, 99.9%) |
| | 25% | 98.1%
(96.1%, 99.1%) | 98.9%
(97.6%, 99.5%) | 99.7%
(98.4%, 99.9%) | 99.7%
(98.5%, 100%) | 99.2%
(97.6%, 99.7%) | 99.3%
(96.5%, 99.9%) |

Table 13: Hypothetical PPV and NPV for BD MAX CTGCTV2

ª The sensitivity and specificity estimates for the patient- and clinician-collected vaginal swabs are similar; the PPV and NPV for vaginal swabs was calculated based on the averages of those estimates.

0.5 mL LBC added to LBC Sample Buffer Tube
Prewarm	Pre-warm only LBC samples prior to extraction	Pre-warm all UVE samples prior to extraction
Extraction	Same	Magnetic affinity beads with protease
On-board lysis	On-board lysis of all specimens	No on-board lysis
Results Metric	Ct score	SDPA with minimum endpoint threshold
	Assay Result Reported	Interpretation of Result	Assay Result Reported	Interpretation of Result
	CT POS	Chlamydia trachomatis DNA Detected	CT POS	Chlamydia trachomatis DNA Detected
	CT NEG	No Chlamydia trachomatis DNA Detected	CT NEG	No Chlamydia trachomatis DNA Detected
Results
Interpretation	CT UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification	CT UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification
	GC POSa	Neisseria gonorrhoeae DNA Detected	GC POS	Neisseria gonorrhoeae DNA Detected
	GC NEG	No Neisseria gonorrhoeae DNA Detected	GC NEG	No Neisseria gonorrhoeae DNA Detected
	GC UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification	GC UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification
	TV POS	Trichomonas vaginalis DNA Detected	TV POS	Trichomonas vaginalis DNA Detected
	TV NEG	No Trichomonas vaginalis DNA Detected	TV NEG	No Trichomonas vaginalis DNA Detected
	TV UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification	TV UNR	Unresolved - Inhibitory sample or reagent failure; no target or Sample Processing Control amplification
	IND	Indeterminate result due to BD MAX System failure (with Warning or Error Codes)	IND	Indeterminate result due to BD MAX System failure (with Warning or Error Codes)
	INC	Incomplete Run (with Warning or Error Codes)	INC	Incomplete Run (with Warning or Error Codes)

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

§ 866.3860

Uwe Scherf -S

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Device Name BD MAX™ CTGCTV2

CONTINUE ON A SEPARATE PAGE IF NEEDED

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *

510(k) Summary BD MAX™ CTGCTV2

Summary Preparation Date:

Submitted by:

Contact:

Proprietary Names:

Common Names:

Regulatory Information

Predicate Device:

Performance Standards:

Intended Use:

Special Conditions for Use Statement: For prescription use

Special Instrument Requirements: BD MAX System

Device Description:

Test Principle:

Substantial Equivalence:

Analytical Performance

Reproducibility

Sample Storage

Controls

Analytical Sensitivity

Analytical Inclusivity

Analytical Specificity

Interfering Substances

Carryover/Cross-Contamination

Mixed Infection/Competitive Interference

Clinical Performance Studies

Clinical Performance of Chlamydia trachomatis and Neisseria gonorrhoeae

Clinical Performance of Trichomonas vaginalis

Clinical Performance of Female Urine

Table 26: Incomplete Rates

Expected Values

Positive and Negative Predictive Value

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.