Who is the manufacturer of BD MAX CTGCTV2, BD MAX System?

Becton, Dickinson and Company filed the 510(k) submission for BD MAX CTGCTV2, BD MAX System (K182692).

What is the FDA product code for BD MAX CTGCTV2, BD MAX System?

OUY. It is classified under 21 CFR 866.3860 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for BD MAX CTGCTV2, BD MAX System?

510(k) clearance (submission type: Traditional).

Does BD MAX CTGCTV2, BD MAX System use AI or machine learning?

Yes. BD MAX CTGCTV2, BD MAX System (K182692) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like BD MAX CTGCTV2, BD MAX System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like BD MAX CTGCTV2, BD MAX System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

BD MAX CTGCTV2, BD MAX System

K182692 · Becton, Dickinson and Company · OUY · Jan 8, 2019 · Immunology

Device Facts

Record ID	K182692
Device Name	BD MAX CTGCTV2, BD MAX System
Applicant	Becton, Dickinson and Company
Product Code	OUY · Immunology
Decision Date	Jan 8, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3860
Device Class	Class 2
Attributes	AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Chlamydia trachomatis (CT) detection	Sensitivity and specificity estimates compared to Patient Infected Status (PIS) or Composite Comparator Algorithm (CCA).	Sensitivity: 98.4% (clinician-collected vaginal), 98.4% (patient-collected vaginal), 94.5% (endocervical), 92.7% (LBC), 96.7% (male urine), 98.4% (female urine). Specificity: 98.9% (clinician-collected vaginal), 98.7% (patient-collected vaginal), 99.2% (endocervical), 99.8% (LBC), 99.4% (male urine), 99.3% (female urine).	Training dataset used for cutoff determination, leveraging previous clinical study data from K151589 for most analytes.	Clinical study of 2,536 female and 1,149 male subjects across 12 geographically diverse clinical collection centers.
Neisseria gonorrhoeae (GC) detection	Sensitivity and specificity estimates compared to Patient Infected Status (PIS) or Composite Comparator Algorithm (CCA).	Sensitivity: 97.7% (clinician-collected vaginal), 100% (patient-collected vaginal), 95.3% (endocervical), 92.9% (LBC), 99.2% (male urine), 100% (female urine). Specificity: 99.9% (clinician-collected vaginal), 99.8% (patient-collected vaginal), 100% (endocervical), 100% (LBC), 99.9% (male urine), 100% (female urine).	Training dataset used for cutoff determination, leveraging previous clinical study data from K151589 for most analytes; GC2 cutoff determined using a separate analytical dataset.	Clinical study of 2,536 female and 1,149 male subjects across 12 geographically diverse clinical collection centers.
Trichomonas vaginalis (TV) detection	Sensitivity and specificity estimates compared to Patient Infected Status (PIS) or Composite Comparator Algorithm (CCA).	Sensitivity: 97.8% (clinician-collected vaginal), 97.9% (patient-collected vaginal), 97.9% (male urine), 100% (female urine). Specificity: 99.6% (clinician-collected vaginal), 99.2% (patient-collected vaginal), 99.7% (male urine), 99.6% (female urine).	Training dataset used for cutoff determination, leveraging previous clinical study data from K151589.	Clinical study of 2,536 female and 1,149 male subjects across 12 geographically diverse clinical collection centers.

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.

Device Story

The BD MAX CTGCTV2 is a molecular diagnostic assay for the qualitative detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA. It is performed on the BD MAX System, a bench-top workstation. Input specimens include vaginal swabs (clinician/patient-collected), endocervical swabs, LBC specimens, and male/female urine. The system automates sample preparation (lysis, DNA extraction/concentration), reagent rehydration, and real-time PCR amplification/detection. The assay uses magnetic affinity beads for DNA capture and hydrolysis (TaqMan) probes for detection. The system automatically interprets results based on target amplification and a Sample Processing Control (SPC). Results are reported as positive, negative, or unresolved. The device is used in clinical laboratories to aid in diagnosing urogenital infections, enabling targeted patient treatment and management.

Clinical Evidence

Clinical trial involved 2,547 female and 1,159 male subjects across 12 sites. Performance compared to Patient Infected Status (PIS) or Composite Comparator Algorithm (CCA). Sensitivity for CT ranged from 92.6% to 98.6% and specificity from 98.5% to 99.8% across specimen types. Sensitivity for GC ranged from 88.9% to 100% and specificity from 99.6% to 100%. Sensitivity for TV ranged from 96.2% to 100% and specificity from 99.1% to 100%. Unresolved rates were low (0.3% or less after repeat).

Technological Characteristics

Real-time PCR assay; automated DNA extraction using magnetic affinity beads and protease; hydrolysis (TaqMan) probes; five optical detection channels; BD MAX System instrument; specimen-specific buffer tubes; LBC specimens require pre-warming; qualitative result reporting.

Indications for Use

Indicated for asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease, and/or trichomoniasis. For use with patient- or clinician-collected vaginal swabs, male/female urine, endocervical swabs, and LBC specimens.

Regulatory Classification

Identification

A Trichomonas 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 by Trichomonas vaginalis.

Special Controls

*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 of*Trichomonas vaginalis;* Guideline for Industry and Food and Drug Administration Staff.” See § 866.1(e) for information on obtaining this document.

Predicate Devices

BD MAX CT/GC/TV (K151589)

Related Devices

K210585 — BD CTGCTV2 · Becton, Dickinson and Company · May 10, 2022
K243343 — BD CTGCTV2 · Bd Integrated Diagnostic Solutions/Becton, · Apr 22, 2025
K151589 — BD MAX CT/GC/TV, BD MAX INSTRUMENT · Becton, Dickinson and Company · Sep 6, 2016

Submission Summary (Full Text)

{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}------------------------------------------------ | 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) | 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): < 1X LoD - True negative (TN): no target Precision study results for the BD MAX CTGCTV2 are described in Table 2. | 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 | 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 | | |--------|----------------|-----|-------------|------|---------------|-----|----------------|-----|----------------|-----|---------------------|-----|-----------------|-----|-------|-----| | | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | GC1 | Swab | HN | 33/96 | 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 | | | Swab | LP | 95/96 | 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 | | | Swab | MP | 96/96 | 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 | | GC1 | Urine | HN | 27/96 | 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 | | | Urine | LP | 95/96 | 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 | | | Urine | MP | 96/96 | 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 | | GC1 | LBCa | HN | 11/96 | 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 | | | LBCa | LP | 94/96 | 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 | | | LBCa | MP | 96/96 | 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 | | GC2 | Swab | HN | 33/96 | 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 | | | Swab | LP | 95/96 | 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 | | | Swab | MP | 96/96 | 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 | | GC2 | Urine | HN | 27/96 | 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 | | | Urine | LP | 95/96 | 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 | | | Urine | MP | 96/96 | 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 | | GC2 | LBCa | HN | 11/96 | 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 | | | LBCa | LP | 94/96 | 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 | | | LBCa | MP | 96/96 | 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 |…

BD MAX CTGCTV2, BD MAX System

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