(179 days)
No.
The device description details a Real-time PCR based assay for qualitative detection of DNA, which involves chemical and optical processes, without any mention of AI, machine learning, or complex algorithms that would suggest an AI model is used for data interpretation or decision-making beyond simple thresholding.
No
This device is an in vitro diagnostic (IVD) assay designed for the qualitative detection of DNA from specific bacteria to aid in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "to aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease and chlamydial and gonococcal extragenital infection." This directly indicates its role in diagnosis.
No
The device is a laboratory assay (BD CTGCTV2) performed on a hardware system (BD COR™ System) that involves physical specimen processing, extraction, amplification, and detection using real-time PCR. It is a diagnostic test kit with associated instrumentation, not a software-only medical device.
Yes
The device is described as an assay for the direct, qualitative detection of DNA from various pathogens (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis) in human specimens (vaginal, urine, endocervical, rectal, oropharyngeal swabs) to aid in the diagnosis of specific diseases. This clearly falls under the definition of an in vitro diagnostic (IVD) device, which is intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information about a physiological state, a state of health or disease, or a congenital abnormality.
N/A
Intended Use / Indications for Use
The BD CTGCTV2 assay 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 ThinPrep® PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep® Pap test. The assay may also be used for the detection of CT and GC DNA in clinician-collected rectal and oropharyngeal swab specimens.
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease and chlamydial and gonococcal extragenital infection.
The BD CTGCTV2 assay is available for use with the BD MAX™ System (urogenital specimens) or the BD COR™ System (urogenital and extragenital specimens), as described above.
Product codes
QEP, LSL, MKZ, OUY, OOI
Device Description
The BD CTGCTV2 assay is a qualitative DNA detection system that uses automated DNA extraction and real-time polymerase chain reaction (PCR). It is designed to detect DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV). The assay is performed on the BD COR™ System, which includes the BD COR™ MX Instrument and BD COR™ PX Instrument for automated sample preparation, extraction, and purification of nucleic acids, as well as amplification and detection of target nucleic acid sequences using fluorescence-based real-time PCR.
The assay uses dried extraction reagents in 96-well microtiter plates containing binding magnetic affinity beads and a Sample Processing Control (SPC). The SPC monitors reagent integrity, and DNA extraction, amplification, and detection processes, and detects potential assay inhibitors. The system also includes a liquid reagent plate with Wash, Elution, and Neutralization buffers, and an additional buffer to rehydrate the dried extraction mix for the BD COR™ System. After elution and neutralization, extracted nucleic acids are transferred to the Amplification reagent to rehydrate PCR reagents and dispensed into a BD PCR Cartridge.
The BD CTGCTV2 assay targets two regions for Chlamydia trachomatis (one optical channel), two targets for Neisseria gonorrhoeae (two distinct optical channels), and one target for Trichomonas vaginalis (one optical channel). Detection of amplified DNA targets is achieved using hydrolysis (TaqMan®) probes labeled with a fluorescent reporter dye and a quencher moiety. The BD COR™ System monitors the fluorescence signals during each PCR cycle to provide qualitative (positive or negative) test results.
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 (in a clinical setting), male and female urine specimens, endocervical swab, Liquid-Based Cytology (LBC) specimens in ThinPrep® PreservCyt® Solution, clinician-collected rectal and oropharyngeal swab specimens.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The performance of the BD CTGCTV2 assay on the BD COR™ System using oropharyngeal and rectal swabs was established by comparing the assay results obtained on the BD COR™ System to a composite comparator algorithm (CCA) comprised of three commercially available NAATs. Specimens were collected from subjects enrolled at eight geographically diverse sites including STD, family planning, HIV, and research clinics. A total of 2,439 subjects were consented to participate in the collection. Of those, 2,375 were found eligible based on pre-determined inclusion/exclusion criteria. A total of 4,652 specimens (oropharyngeal and rectal swabs) were considered eligible for randomization into the study, of which 4,579 were considered eligible for testing (2,303 oropharyngeal swabs and 2,276 rectal swabs). A positive or negative CCA result was defined by the concurrence of at least 2 out of 3 commercially available NAAT assay results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Evaluation:
The focus of this submission is the addition of extragenital specimen claims (rectal and oropharyngeal) for testing Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC); TV was not assessed for extragenital specimens.
- Limit of Detection (LoD): The LoD was determined for CT and GC in rectal and oropharyngeal matrix. Microbial suspensions of two representative strains for each target organism were used. LoD ranged from 1.25 to 25 units/mL. For C. trachomatis, LoD was 2.5 EBs/mL to 1.875 EBs/mL in rectal and oropharyngeal samples, respectively. For N. gonorrhoeae, LoD was 25 CFU/mL to 10 CFU/mL in rectal and oropharyngeal samples, respectively.
- Inclusivity: Evaluated the detection of 13 additional C. trachomatis serovars and 30 N. gonorrhoeae strains in rectal and oropharyngeal matrices when spiked at 2x LoD. Four organisms did not confirm at 2x LoD initially and required titration. All were detected at 100% at their determined lower LoD levels.
- Cross-Reactivity: Evaluated on the BD COR™ System using phylogenetically related microorganisms found in extragenital specimens. Bacteria, yeasts, parasites, and viruses were tested at specified concentrations. All tested organisms produced negative results with the BD CTGCTV2 assay, showing analytical specificity.
- Microbial Interference: Assessed potential interference of 25 organisms for rectal and 31 for oropharyngeal specimens with CT and GC detection. C. trachomatis and N. gonorrhoeae were co-spiked with interfering organisms at 3x LoD. Both low target organisms were successfully detected at >= 95% in the presence of other high-concentration organisms in rectal and oropharyngeal specimens.
- Interfering Substances: Evaluated 39 biological and chemical substances potentially present in extragenital specimens (e.g., antibiotics, medications, personal care products). Negative and 3x LoD positive samples (CT and GC) were tested with high concentrations of each compound. Substances like zinc oxide, feces, fecal fat, and whole blood (for rectal) and Beconase AQ, Prilosec, toothpaste, and whole blood (for oropharyngeal) showed potential interference at higher concentrations than tested. Most tested substances did not cause interference.
- Specimen Stability: Extragenital swab specimens in BD Molecular Swab Sample Buffer Tube are stable for up to 21 days at 2–30 °C. Pierced caps can be stored upright for up to 4 days within the 21-day total.
Clinical Performance Study for Extragenital Specimens:
- Study Type: Multi-center clinical study comparing BD CTGCTV2 assay results on BD COR™ System to a composite comparator algorithm (CCA) of three commercially available NAATs.
- Sample Size: 2,439 subjects consented, 2,375 eligible, 4,652 specimens (2,303 oropharyngeal swabs and 2,276 rectal swabs) considered eligible for testing.
- Key Results:
- CT Sensitivity: Rectal samples: 97.7% (129/132), Oropharyngeal samples: 100% (24/24).
- GC Sensitivity: Rectal samples: 95.8% (91/95), Oropharyngeal samples: 92.8% (90/97).
- CT Specificity: Rectal samples: 99.4% (2,130/2,142), Oropharyngeal samples: 99.8% (2,269/2,274).
- GC Specificity: Rectal samples: 99.8% (2,177/2,181), Oropharyngeal samples: 99.5% (2,194/2,206).
- Non-Reportable Results: The combined non-reportable rate on initial test across all sample types and combined targets was 0.6%. No incomplete (INC) results were observed.
- CT Target:
- Oropharyngeal: Initial Total Rate: 0.7% (16/2,307). Valid Repeat Total Rate: 0.0% (1/2,306).
- Rectal: Initial Total Rate: 0.5% (11/2,279). Valid Repeat Total Rate: 0.0% (1/2,278).
- Total (Both Specimen Types): Initial Total Rate: 0.6% (27/4,586). Valid Repeat Total Rate: 0.0% (2/4,584).
- GC Target:
- Oropharyngeal: Initial Total Rate: 0.7% (16/2,307). Valid Repeat Total Rate: 0.0% (1/2,306).
- Rectal: Initial Total Rate: 0.4% (9/2,279). Valid Repeat Total Rate: 0.0% (1/2,278).
- Total (Both Specimen Types): Initial Total Rate: 0.5% (25/4,586). Valid Repeat Total Rate: 0.0% (2/4,584).
- Combined CT and GC Targets:
- Oropharyngeal: Initial Total Rate: 0.7% (16/2,307). Valid Repeat Total Rate: 0.0% (1/2,306).
- Rectal: Initial Total Rate: 0.5% (11/2,279). Valid Repeat Total Rate: 0.0% (1/2,278).
- Total (Both Specimen Types): Initial Total Rate: 0.6% (27/4,586). Valid Repeat Total Rate: 0.0% (2/4,584).
- CT Target:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Performance (BD CTGCTV2 Assay on BD COR™ System vs. CCA):
- CT (Chlamydia trachomatis):
- Oropharyngeal:
- PPA: 100% (24/24) (95% CI: 86.2–100)
- NPA: 99.8% (2,269/2,274) (95% CI: 99.5–99.9)
- Rectal:
- PPA: 97.7% (129/132) (95% CI: 93.5–99.2)
- NPA: 99.4% (2,130/2,142) (95% CI: 99.0–99.7)
- Oropharyngeal:
- GC (Neisseria gonorrhoeae):
- Oropharyngeal:
- PPA: 92.8% (90/97) (95% CI: 85.8–96.5)
- NPA: 99.5% (2,194/2,206) (95% CI: 99.1–99.7)
- Rectal:
- PPA: 95.8% (91/95) (95% CI: 89.7–98.4)
- NPA: 99.8% (2,177/2,181) (95% CI: 99.5–99.9)
- Oropharyngeal:
Hypothetical Predictive Values for Extragenital Specimens (at various prevalence rates):
- Oropharyngeal CT:
- PPV: 82.1% (1% prevalence) to 99.3% (25% prevalence)
- NPV: 100% (1% prevalence) to 100% (25% prevalence)
- Oropharyngeal GC:
- PPV: 63.3% (1% prevalence) to 98.3% (25% prevalence)
- NPV: 99.9% (1% prevalence) to 97.6% (25% prevalence)
- Rectal CT:
- PPV: 63.8% (1% prevalence) to 98.3% (25% prevalence)
- NPV: 100% (1% prevalence) to 99.2% (25% prevalence)
- Rectal GC:
- PPV: 84.1% (1% prevalence) to 99.4% (25% prevalence)
- NPV: 100% (1% prevalence) to 98.6% (25% prevalence)
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
(a)
Identification. A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) and their associated resistance markers in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist that are not detected by the device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate;
(iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) Limiting statements indicating that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(D) If appropriate (
e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type; and(v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that:
(A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present;
(B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora;
(C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and
(D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy.
(4) Design verification and validation must include:
(i) Detailed device description documentation, including methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (
e.g., how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate.
(iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses.
(iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.
FDA 510(k) Clearance Letter - BD CTGCTV2
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 22, 2025
BD Integrated Diagnostic Solutions/Becton, Dickinson & Company
Teresa Jennifer Sugumar
Staff Regulatory Affairs Specialist
7 Loveton Circle
Sparks, Maryland 21152
Re: K243343
Trade/Device Name: BD CTGCTV2
Regulation Number: 21 CFR 866.3393
Regulation Name: Device To Detect Nucleic Acids From Non-Viral Microorganism(S) Causing Sexually Transmitted Infections And Associated Resistance Marker(S)
Regulatory Class: Class II
Product Code: QEP
Dated: October 25, 2024
Received: October 25, 2024
Dear Teresa Jennifer Sugumar:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K243343 - Teresa Jennifer Sugumar Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243343 - Teresa Jennifer Sugumar Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Himani Bisht -S
Himani Bisht, Ph.D.
Assistant Director
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243343
Device Name: BD CTGCTV2
Indications for Use (Describe)
The BD CTGCTV2 assay 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 ThinPrep® PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep® Pap test. The assay may also be used for the detection of CT and GC DNA in clinician-collected rectal and oropharyngeal swab specimens.
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease and chlamydial and gonococcal extragenital infection.
The BD CTGCTV2 assay is available for use with the BD MAX™ System (urogenital specimens) or the BD COR™ System (urogenital and extragenital specimens), as described above.
Type of Use (Select one or both, as applicable)
☒ 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
"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."
Page 5
510(k) Summary BD CTGCTV2
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 1 of 20
Summary Preparation Date:
10/25/2024
Submitted by:
Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Contact:
Teresa Jennifer Sugumar, MS
Staff Regulatory Affairs Specialist
Tel: (862) 376-7814
Email: teresa.jennifer.sugumar@bd.com
Device
Trade Name/Device Name: BD CTGCTV2
Proprietary Names
For the instrument:
BD COR™ System
For the assay:
BD CTGCTV2
Common Names
For the instrument:
High-throughput molecular system
For the assay:
CT, GC and TV assay
Page 6
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 2 of 20
Regulatory Information
Regulation section:
21 CFR §866.3393, Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Classification:
Class II
Panel:
Microbiology
Product Code(s):
- QEP - Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- LSL - DNA-Reagents, Neisseria
- MKZ - DNA Probe, Nucleic Acid Amplification, Chlamydia
- OUY - Trichomonas Vaginalis Nucleic Acid Amplification Test System
- OOI - Real time nucleic acid amplification system
Predicate Device:
Trade Name/Device Name: BD CTGCTV2
510(k) Number: (K210585)
Device Establishment:
Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152
Registration Number: 1119779
Performance Standards:
- ISO 13485: 2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14971 Third Edition 2019-12 – Medical devices – Application of risk management to medical devices
Page 7
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 3 of 20
- ISO 14155 Third edition 2020-07 – Clinical investigation of medical devices for human subjects – Good clinical practice
- ISO 20417 First edition 2021-04 Corrected version 2021 – Medical devices –Information to be supplied by the manufacturer
- ISO 15223-1 Fourth edition 32021-07 – Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1 General requirements
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION – Medical device software – Software life cycle processes
- IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION – Medical devices – Part 1: Application of usability engineering to medical devices
- CLSI MM03-ED3:2015 Molecular Diagnostic Methods for Infectious Diseases, Third Edition
- CLSI MM13-ED2:2020 Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, Second Edition
- CLSI EP05-A3:2019 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
- CLSI EP25-A:2009 Evaluation of Stability of In Vitro Diagnostic Reagents, First Edition
FDA Guidance:
21 CFR §866.3393, Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Intended Use:
The BD CTGCTV2 assay 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 ThinPrep® PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep® Pap test. The assay may also be used for the detection of CT and GC DNA in clinician-collected rectal and oropharyngeal swab specimens.
Page 8
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 4 of 20
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease and chlamydial and gonococcal extragenital infection.
The BD CTGCTV2 assay is available for use with the BD MAX™ System (urogenital specimens) or the BD COR™ System (urogenital and extragenital specimens), as described above.
Special Conditions for Use Statement:
- For Prescription Use Only
- For in vitro diagnostic use only
Special Instrument Requirements:
BD CTGCTV2 is performed on the BD COR™ System.
Principles of the Procedure
The BD CTGCTV2 assay, performed on the BD COR™ System (hereafter referred to as BD CTGCTV2), is designed for use with the applicable BD Molecular specimen collection and transport devices for male and female urine, rectal swabs, oropharyngeal swabs, vaginal swabs, endocervical swabs, and LBC specimens (PreservCyt®). Specimens are collected and transported to the testing laboratory using their respective transport devices under conditions of time and temperature that have been determined to maintain the integrity of the target nucleic acids.
The BD COR™ MX Instrument, when combined with the BD COR™ PX Instrument, is to be used for automated sample preparation, extraction, and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR for simultaneous and differential detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
The BD CTGCTV2 assay extraction reagents are dried in 96-well microtiter plates that contain binding magnetic affinity beads and Sample Processing Control (SPC). Each tube is capable of binding and eluting sample nucleic acids. The SPC monitors the integrity of the reagents and the process steps involved in DNA extraction, amplification and detection, as well as for the presence of potential assay inhibitors.
The BD CTGCTV2 assay liquid reagent plate includes Wash, Elution and Neutralization buffers. The beads (described above), together with the bound nucleic acids, are washed and the nucleic acids are eluted by a combination of heat and pH. When performed on BD COR™ System, there is an additional buffer to rehydrate the dried extraction mix. Eluted DNA is neutralized and transferred to the Amplification reagent (described below) to rehydrate the PCR reagents. After reconstitution, the BD COR™ System dispenses a fixed volume of PCR-ready solution containing extracted nucleic acids into the BD PCR Cartridge. Microvalves in the BD
Page 9
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 5 of 20
PCR Cartridge are sealed by the system prior to initiating PCR in order to contain the amplification mixture and thus prevent evaporation and contamination.
The BD 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 the target analytes in different optical channels of the BD COR™ 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 COR™ System monitors these signals at each cycle of the PCR and interprets the data at the end of the reaction to provide qualitative test results for each analyte (i.e., positive or negative).
Substantial Equivalence¹:
Table 1 provides the similarities and differences between the BD CTGCTV2, respectively, in comparison to the predicate device, BD CTGCTV2.
¹ The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
Page 10
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 6 of 20
Table 1. Comparison of the Subject Device to the Predicate Device
| Device and Predicate Device | Subject Device | Predicate Device |
|---|---|---|
| Device Trade Name | BD CTGCTV2 | BD CTGCTV2 |
| Device 510(k) Number | - | K210585 |
| Regulation | 21 CFR 866.3393 | 21 CFR 866.3393 |
| Product Code | QEP, OUY, LSL, MKZ, OOI | QEP, OUY, LSL, MKZ |
| Device Class | II | II |
| Intended Use | The BD CTGCTV2 assay 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 ThinPrep® PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep® Pap test. The assay may also be used for the detection of CT and GC DNA in clinician-collected rectal and oropharyngeal swab specimens.
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease and chlamydial and gonococcal extragenital infection.
The BD CTGCTV2 assay is available for use with the BD MAX™ System (urogenital specimens) or the BD | The BD CTGCTV2 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 ThinPrep® 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 CTGCTV2 assay is available for use with the BD MAX™ System or the BD COR™ System. |
Page 11
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 7 of 20
| Device and Predicate Device | Subject Device | Predicate Device |
|---|---|---|
| COR™ System (urogenital and extragenital specimens), as described above. | ||
| Indications for Use | Same | Asymptomatic and Symptomatic Patients |
| Specimen Type | Clinician-collected vaginal swab, patient collected vaginal swab, endocervical swab, PreservCyt LBC, female and male urine, rectal and oropharyngeal swab | Clinician-collected vaginal swab, patient collected vaginal swab, endocervical swab, PreservCyt LBC, female and male urine |
| On-Board Lysis (OBL) | 30' OBL for urogenital samples | |
| 10' OBL for LBC samples | ||
| 10' OBL for extragenital samples | 30' OBL for urogenital samples | |
| 10' OBL for LBC samples | ||
| Technology | Same | PCR |
| Organisms Detected | Same | CT, GC, and TV |
| Sample Prep/BD COR™ of Results | Same | Automated by BD COR™ System |
| Assay Controls | Same | Sample Processing Control |
| Target Detection | Same | Target Dye Channel |
| CT | FAM | FAM |
| CT | FAM | FAM |
| GC (GC1) | CFO | VIC |
| GC (GC2) | Q705 | CY5.5 |
| TV | Q670 | CY5 |
| Collection/ Transport Device | Same | |
| Note: Rectal and oropharyngeal samples will utilize existing Swab Sample Buffer Tube (2.0 mL) | Swab Sample Buffer Tube (2.0 mL) | |
| Urine Sample Buffer Tube (0.5 mL) | ||
| LBC Sample Buffer Tube (1.5 mL) | ||
| Sample Prep | Same | |
| Note: Rectal and oropharyngeal samples will utilize existing prep of 1 swab added to Swab Sample Buffer Tube | 1 swab added to Swab Sample Buffer Tube | |
| 2.0 mL urine added to Urine Sample Buffer Tube | ||
| 0.5 mL LBC added to LBC Sample Buffer Tube |
Page 12
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 8 of 20
Analytical Performance Evaluation
The focus of this submission is the addition of extragenital specimen claims (rectal and oropharyngeal) for testing Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC); TV was not assessed for extragenital specimens.
Limit of Detection (LoD)
The analytical sensitivity/Limit of Detection (LoD) of the BD CTGCTV2 assay in rectal and oropharyngeal matrix was determined as follows: A microbial suspension was prepared from each of two (2) representative strains of the target organisms detected by the BD CTGCTV2 assay. Each target organism was quantified prior to testing. Positive specimens were prepared by inoculating pooled rectal and oropharyngeal swabs in sample buffer with multiple concentrations of each representative serovar/strain. Each matrix suspension was tested with at least 20 replicates per concentration using at least 2 BD COR™ Systems and 2 reagent lots of the BD CTGCTV2 assay. Analytical sensitivity (LoD), defined as the lowest concentration at which at least 95% of all replicates tested positive, ranged from 1.25 to 25 units/mL. The Limit of Detection results are presented in Table 2.
Table 2. Limit of Detection of the BD CTGCTV2 Assay for Extragenital Sample Types
| Organism | Strain | Specimen | LoD Concentration (units/mL)ᵃ |
|---|---|---|---|
| Chlamydia trachomatis | Serovar H | Rectal | 2.5 |
| Oropharyngeal | 1.875 | ||
| Serovar D | Rectal | 2.5 | |
| Oropharyngeal | 1.25 | ||
| Neisseria gonorrhoeae | ATCC® 19424 | Rectal | 25 |
| Oropharyngeal | 20 | ||
| ATCC® 49226 | Rectal | 20 | |
| Oropharyngeal | 10 |
ᵃ Units/mL LoD concentration represented in Elementary Bodies (EB)/mL for Chlamydia trachomatis and CFU/mL for Neisseria gonorrhoeae.
Inclusivity
The analytical reactivity of the BD CTGCTV2 assay was evaluated on the BD COR™ System. The study evaluated the ability of the BD CTGCTV2 assay to detect clinically relevant and geographically diverse serovars and/or strains of Chlamydia trachomatis and Neisseria gonorrhoeae when tested in rectal and oropharyngeal matrices. The study included thirteen (13) additional Chlamydia trachomatis serovars (A, B, C, E, F, G, I, J, K, LGV1, LGV2, LGV3, and vE) and thirty (30) Neisseria gonorrhoeae strains. These 43 serovars/strains, which represented public collections and well-characterized clinical isolates, were spiked into rectal and oropharyngeal pools prepared in sample buffer at 2x LoD for each organism. Each serovar/strain was tested in 3 replicates. Of the 43 organisms tested, four (4) which did not confirm at 2x LoD, upon initial testing and required titration. The results for Chlamydia trachomatis and Neisseria
Page 13
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 9 of 20
gonorrhoeae are presented in Table 3 and Table 4 and show the LoD level which were detected at 100%.
Table 3. Inclusivity Results (Performed on BD COR™ System) – Chlamydia trachomatis
| Organism | Serovar | Rectal EBs/mL | Oropharyngeal EBs/mL |
|---|---|---|---|
| Chlamydia trachomatis | A | 5 | 3.75 |
| B | 5 | 3.75 | |
| C | 5 | 3.75 | |
| E | 5 | 3.75 | |
| F | 5 | 3.75 | |
| G | 5 | 3.75 | |
| I | 10 | 7.50 | |
| J | 5 | 3.75 | |
| K | 5 | 3.75 | |
| LGV1ᵃ | 37 | 63 | |
| LGV2ᵃ | 32 | 40 | |
| LGV3ᵃ | 40 | 79 | |
| vE | 5 | 3.75 |
ᵃ LGV1, LGV2, and LGV3 were assessed as genomic DNA in copies/mL but were diluted to a level that was comparable to 2x LoD.
Table 4. Inclusivity Results (Performed on BD COR™ System) – Neisseria gonorrhoeae
| Organism | Strain | Rectal CFU/mL | Oropharyngeal CFU/mL |
|---|---|---|---|
| Neisseria gonorrhoeae | 27 | 50 | 40 |
| 3 | 75 | 60 |
Cross-Reactivity
The analytical specificity/cross-reactivity of the BD CTGCTV2 assay for extragenital specimens was evaluated on the BD COR™ System. The BD CTGCTV2 assay was performed on samples containing phylogenetically related microorganisms likely to be found in extragenital specimens. The bacterial cells, yeasts and parasites were tested in the Sample Buffer Tube at 1x10⁶ cells/mL, genomic DNA cp/mL, cysts/mL or EB/mL. Viruses were tested at 1x10⁵ viral particles (PFU), TCID₅₀ or genomic equivalents/mL. Five (5) microorganisms Entamoeba histolytica, Enterovirus, Giardia lamblia, Human metapneumovirus, and Rhinovirus were tested at lower concentrations which are listed below in Table 5. BD CTGCTV2 assay performed on the BD COR™ System has been shown to be equivalent on the BD MAX™ System under K210585 and some microorganisms were leveraged from previous analytical studies. All bacterial strains, yeast, parasites and viruses assessed produced negative results with the BD CTGCTV2 assay. Organisms for rectal and oropharyngeal specimen types that were tested are represented in Table 5.
Page 14
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 10 of 20
Table 5. BD CTGCTV2 Assay Specificity Organisms (Bacteria, Yeasts, Parasites and Viruses) Specific to Extragenital Specimen Types
| Organism | Organism | Organism |
|---|---|---|
| Acinetobacter baumannii | Giardia lambliaᶜ | Proteus mirabilis |
| Adenovirus | Helicobacter pylori | Providencia stuartii |
| Aggregatibacter actinomycetemcomitans | Herpes simplex virus 1 | Pseudomonas aeruginosa |
| Anaerococcus tetradius | Human influenza virus A | Respiratory syncytial virus |
| Arcanobacterium haemolyticum | Human influenza virus B | Rhinovirusᵉ |
| Bifidobacterium adolescentis | Human metapneumovirusᵈ | Saccharomyces cerevisiae |
| Bordetella pertussis | Klebsiella pneumoniae | Salmonella enterica serovar Minnesota |
| Campylobacter rectus | Lactobacillus acidophilus | Shigella sonnei |
| Candida albicans | Listeria monocytogenes | Staphylococcus aureus |
| Clostridium difficile | Moraxella catarrhalis | Streptococcus agalactiae |
| Coronavirus | Morganella morganii | Streptococcus anginosus |
| Corynebacterium diphtheriae | Mycoplasma pneumoniae | Streptococcus dysgalactiae |
| Entamoeba histolyticaᵃ | Norovirus | Tannerella forsythus (Bacteroides forsythus) |
| Enterobacter cloacae | Parvimonas micra (Peptostreptococcus micros) | Treponema denticola |
| Enterococcus faecalis | Porphyromonas gingivalis | Veillonella parvula |
| Enterovirusᵇ | Prevotella bivia | Vibrio cholerae |
| Fusobacterium necrophorum | Prevotella oralis (Bacteroides oralis) | Yersinia enterocolitica |
ᵃ Entamoeba histolytica tested at 5x10³ cells/mL.
ᵇ Enterovirus tested at 1x10⁴ TCID₅₀/mL.
ᶜ Giardia lamblia tested at 1x10⁵ cysts/mL.
ᵈ Human metapneumovirus tested at 5x10³ cp/mL.
ᵉ Rhinovirus tested at 3x10³ TCID₅₀/mL.
Microbial Interference
Microbial Interference of the BD CTGCTV2 assay for extragenital specimens was evaluated on the BD COR™ System. A total of twenty-five (25) organisms for Rectal and thirty-one (31) organisms for Oropharyngeal were evaluated for potential interference with the BD CTGCTV2 assay. Bacterial cells, yeasts and parasites were tested in the Sample Buffer Tube at 1x10⁶cells/mL, genomic DNA cp/mL, cysts/mL or EB/mL. Viruses were tested at 1x10⁵ viral particles (PFU), TCID₅₀ or genomic equivalents/mL. Five (5) microorganisms Entamoeba histolytica, Enterovirus, Giardia lamblia, Human metapneumovirus, and Rhinovirus were tested at lower concentrations which are listed below in Table 6 and Table 7. Chlamydia trachomatis and Neisseria gonorrhoeae was co-spiked with all organisms at a 3x level. Organism assessed where Chlamydia trachomatis and Neisseria gonorrhoeae were detected at 100% in rectal and oropharyngeal specimens are represented in Table 6 and Table 7.
Page 15
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 11 of 20
Table 6. BD CTGCTV2 Assay Microbial Interference Specific to Rectal Specimen
| Organism | Organism | Organism |
|---|---|---|
| Acinetobacter baumannii | Helicobacter pylori | Salmonella enterica serovar Minnesota |
| Anaerococcus tetradius | Lactobacillus acidophilus | Shigella sonnei |
| Bifidobacterium adolescentis | Listeria monocytogenes | Staphylococcus aureus |
| Clostridium difficile | Morganella morganii | Streptococcus agalactiae |
| Entamoeba histolyticaᵃ | Norovirus | Streptococcus dysgalactiae |
| Enterobacter cloacae | Prevotella bivia | Vibrio cholerae |
| Enterococcus faecalis | Proteus mirabilis | Yersinia enterocolitica |
| Enterovirusᵇ | Providencia stuartii | |
| Giardia lambliaᶜ | Pseudomonas aeruginosa |
ᵃ Entamoeba histolytica tested at 5x10³ cells/mL.
ᵇ Enterovirus tested at 1x10⁴ TCID₅₀/mL.
ᶜ Giardia lamblia tested at 1x10⁵ cysts/mL.
Table 7. BD CTGCTV2 Assay Microbial Interference Specific to Oropharyngeal Specimen
| Organism | Organism | Organism |
|---|---|---|
| Adenovirus | Human influenza virus B | Respiratory syncytial virus |
| Aggregatibacter actinomycetemcomitans | Human metapneumovirusᵃ | Rhinovirusᵇ |
| Arcanobacterium haemolyticum | Klebsiella pneumoniae | Saccharomyces cerevisiae |
| Bordetella pertussis | Lactobacillus acidophilus | Staphylococcus aureus |
| Campylobacter rectus | Moraxella catarrhalis | Streptococcus anginosus |
| Candida albicans | Mycoplasma pneumoniae | Streptococcus dysgalactiae |
| Coronavirus | Parvimonas micra (Peptostreptococcus micros) | Tannerella forsythus (Bacteroides forsythus) |
| Corynebacterium diphtheriae | Porphyromonas gingivalis | Treponema denticola |
| Fusobacterium necrophorum | Prevotella bivia | Veillonella parvula |
| Herpes simplex virus 1 | Prevotella oralis (Bacteroides oralis) | |
| Human influenza virus A | Pseudomonas aeruginosa |
ᵃ Human metapneumovirus tested at 5x10³ cp/mL.
ᵇ Rhinovirus tested at 3x10³ TCID₅₀/mL.
Interfering Substances
The interfering substances study of the BD CTGCTV2 assay was performed on the BD COR™ System for extragenital specimens. Thirty-nine (39) biological and chemical substances that may be present in extragenital specimens were evaluated for potential interference with the BD CTGCTV2 assay. Included in this study were antibiotic, over the counter medications, astringents, antiseptics, lubricants, contraceptives, and biological substances that were tested at a
Page 16
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 12 of 20
concentration that may be found in extragenital specimens. Negative rectal and oropharyngeal pooled specimens and a target mix of Chlamydia trachomatis and Neisseria gonorrhoeae positive at 3x LoD were tested with the highest amount of each compound likely to be found in the specimens. Potentially interfering substances in rectal specimens include zinc oxide, feces, fecal fat (stearic acid) and whole blood. Potentially interfering substances in oropharyngeal specimens include Beconase AQ, Prilosec, toothpaste, and whole blood. The following substances shown in Table 8 and Table 9 did not cause interference with the BD CTGCTV2 assay at the concentrations shown below.
Table 8. Exogenous and Endogenous Substances Tested for Interference in Rectal Swab Specimens
| Substance | Concentration |
|---|---|
| Vaseline (Petroleum Jelly) | 5% |
| Miconazole Nitrate Cream | 2% w/v |
| Zinc Oxide | 10% w/w pasteᵃ |
| Hemorrhoid Gel (Phenylephrine HCL) | 2% w/v |
| Hemorrhoid Gel (Witch Hazel) | 3.75% |
| Bactroban (Mupirocin) | 3.75% |
| Mineral Oil | 2% v/v |
| Imodium (Leperamide HCL) | 0.00667 mg/mL |
| Condoms (Nonoxynol-9) | 7% v/v |
| Ex-Lax (Sennosides) | 0.1 mg/mL |
| Moist Towelettes (Benzalkonium Chloride) | 0.12% w/v |
| Gaviscon (Aluminum Hydroxide/Magnesium Carbonate) | 0.1 mg/mL |
| Feces | 1.75%ᵃ |
| Fecal Fat (Palmitic acid) | 2 mg/mL |
| Fecal Fat (Stearic Acid) | 1 mg/mLᵃ |
| Whole Blood | 5 µL/mLᵃ |
| KY Lubricating Jelly | 137.5 mg/mL |
| Mucous (Bovine Cervical) | 5.0% v/v |
ᵃ May interfere with the BD CTGCTV2 assay when at concentrations higher than shown.
Table 9. Exogenous and Endogenous Substances Tested for Interference in Oropharyngeal Swab Specimens
| Substance | Concentration |
|---|---|
| Neo-synephrine | 3.75% |
| Afrin Nasal Spray (Oxymetazoline HCL) | 7.5 mg/mL |
| Zicam Nasal Gel (Zinc Acetate) | 20% |
| Saline Nasal Spray | 15% |
| Relenza (Zanamivir) | 45% v/v (1 mg) |
| Tobrex 0.3% (Tobramycin) | 9% v/v (0.27 mg) |
| Rebetol (Ribavrin) | 5 ng/mL |
| TamiFlu (Oseltamivir) | 7.5 mg/mL |
Page 17
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 13 of 20
| Substance | Concentration |
|---|---|
| Beconase AQ (Beclomethasone dipropionate) | 1.75%ᵃ |
| Tums (Calcium Carbonate) | 0.5 mg/mL |
| Pepto Bismol (Bismuth Subsalicylate) | 0.87 mg/mL |
| Tagamet | 0.5 mg/mL |
| Prilosec (delayed release) (Omeparazole Magnesium) | 0.25 mg/mLᵃ |
| Vancomycin HCL | 12.5 mg/mL |
| Sucrets lozenges (Menthol Dyclonine) | 10 mg/mL |
| Barium Sulfate | 5 mg/mL |
| Chloraseptic Spray (Menthol/Benzocaine/Dextromethorphan Hydrobromide) | 10 mg/mL |
| Toothpaste (Sodium Monoflurophosphate) | 10 mg/mLᵃ |
| Mouthwash (Cetylpyridinium Chloride/ Domiphen Dromide /Denatured Alcohol) | 25% v/v |
| Lip Balm (Camphor/Menthol/ Petolatum/Phenol) | 5 mg/mL |
| Cold Sore medication (Docosanol) | 10 mg/mL |
| Whole Blood | 10 µL/mLᵃ |
| Mucous (Bovine Cervical) | 5.0% v/v |
ᵃ May interfere with the BD CTGCTV2 assay when at concentrations higher than shown.
Mixed Infection/Competitive Interference
The mixed infection/competitive interference study of the BD CTGCTV2 assay was performed on the BD COR™ System for Extragenital specimen. The mixed infection/competitive interference study was designed to evaluate the ability of the BD CTGCTV2 assay to detect low concentrations of the target organisms in the presence of high concentration of the other two target organisms. Three test samples were prepared in pooled clinical matrix (rectal and oropharyngeal) each containing one of the target organisms (Chlamydia trachomatis and Neisseria gonorrhoeae) at 1.5x their respective LoD. A high target mix comprised of organisms representative of the other two BD CTGCTV2 assay analytes at a concentration ≥1 x 10⁶ EB, CFU or TV/mL were spiked into each sample to simulate mixed infections. The samples were tested in 20 replicates. All two low target organisms were successfully detected at ≥95% by the BD CTGCTV2 assay in the presence of the other two organisms at high concentrations in rectal and oropharyngeal specimens.
Specimen Stability
Extragenital Swab specimens must be transferred to a BD Molecular Swab Sample Buffer Tube immediately after collection. Once in the BD Molecular Sample Buffer Tube, the swab specimens can be stored for a total of 21 days at 2–30 °C. A Sample Buffer Tube with a pierced cap can be stored upright for up to 4 days (included in the 21 days total storage duration) at 2–30 °C (Table 10).
Page 18
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 14 of 20
Table 10. Swab Specimen Storage and Transport
| Specimen Stability | Transport and/or Storage Time/Temperature |
|---|---|
| In BD Molecular Swab Sample Buffer Tube | Up to 21 days at 2–30 °C |
| Upon puncture of BD Pierceable Caps | Up to 4 days punctured within 21 days at 2–30 °C |
Expected Values
Positivity for Extragenital Specimens
The positivity rate of the BD CTGCTV2 assay on the BD COR™ System with extragenital specimens, as observed during the multi-center clinical study, is shown by specimen type in Table 11 below.
Table 11. Positivity Rate with BD COR™ System by Symptomatic Status, Target, and Specimen Type
| Symptomatic Status | Specimen Type | Positivity Rate |
|---|---|---|
| CT | ||
| Asymptomatic | Oropharyngeal | 1.4% 21/1,553 |
| Rectal | 5.7% 88/1,537 | |
| Symptomatic | Oropharyngeal | 1.2% 9/735 |
| Rectal | 7.5% 54/723 | |
| Unknown | Oropharyngeal | 0.0% 0/17 |
| Rectal | 0.0% 0/17 | |
| Total | Oropharyngeal | 1.3% 30/2,305 |
| Rectal | 6.2% 142/2,277 |
Hypothetical Predictive Values for Extragenital Specimens
Table 12 provides positive and negative predictive values based on hypothetical prevalence rates.
Page 19
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 15 of 20
Table 12. Positive and Negative Predictive Values Based on Hypothetical Prevalence
| Specimen Type | Hypothetical Prevalence | Estimate (95% CI) |
|---|---|---|
| CT | ||
| PPV | ||
| Oropharyngeal | 1% | 82.1% (66.3, 93.4) |
| 2% | 90.3% (79.9, 96.6) | |
| 5% | 96.0% (91.1, 98.7) | |
| 10% | 98.1% (95.6, 99.4) | |
| 15% | 98.8% (97.2, 99.6) | |
| 20% | 99.1% (98.0, 99.7) | |
| 25% | 99.3% (98.5, 99.8) | |
| Rectal | 1% | 63.8% (50.6, 76.8) |
| 2% | 78.1% (67.4, 87.0) | |
| 5% | 90.2% (84.2, 94.5) | |
| 10% | 95.1% (91.9, 97.3) | |
| 15% | 96.9% (94.7, 98.3) | |
| 20% | 97.8% (96.2, 98.8) | |
| 25% | 98.3% (97.1, 99.1) |
Clinical Performance Study for Extragenital Specimens
The performance of the BD CTGCTV2 assay on the BD COR™ System using oropharyngeal and rectal swabs was established by comparing the assay results obtained on the BD COR™ System to a composite comparator algorithm (CCA) comprised of three commercially available NAATs. Specimens were collected from subjects enrolled at eight geographically diverse sites including STD, family planning, HIV, and research clinics. The performance (sensitivity and specificity) of the BD CTGCTV2 assay on the BD COR™ System versus the CCA was evaluated. A positive or negative CCA result was defined by the concurrence of at least 2 out of 3 commercially available NAAT assay results.
A total of 2,439 subjects were consented to participate in the collection. Of those, 2,375 were found eligible based on pre-determined inclusion/exclusion criteria. A total of 4,652 specimens (oropharyngeal and rectal swabs) were considered eligible for randomization into the study, of
Page 20
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 16 of 20
which 4,579 were considered eligible for testing (2,303 oropharyngeal swabs and 2,276 rectal swabs). The sensitivity for the CT target was 97.7% (129/132) for rectal samples and 100% (24/24) for oropharyngeal samples. The sensitivity for the GC target was 95.8% (91/95) for rectal samples and 92.8% (90/97) for oropharyngeal samples. The specificity for the CT target was 99.4% (2,130/2,142) for rectal samples and 99.8% (2,269/2,274) for oropharyngeal samples. The specificity of the GC target was 99.8% (2,177/2,181) for rectal samples and 99.5% (2,194/2,206) for oropharyngeal samples (Table 13).
Table 13. Clinical Performance of BD CTGCTV2 Assay on BD COR™ System for Extragenital Specimens Compared to CCA, by Symptomatic Status, Target, and Specimen Type
| Symptomatic Status | Specimen Type | CT | GC | ||
|---|---|---|---|---|---|
| PPA (%) (95% CI) | NPA (%) (95% CI) | PPA (%) (95% CI) | NPA (%) (95% CI) | ||
| Asymptomatic | Oropharyngeal | 100 17/17 (81.6–100) | 99.8 1,526/1,529 (99.4–99.9) | 93.5 43/46 (82.5–97.8) | 99.4 1,498/1,507 (98.9–99.7) |
| Rectal | 97.6 81/83 (91.6–99.3) | 99.5 1,446/1,453 (99.0–99.8) | 100 50/50 (92.9–100) | 99.9 1,486/1,487 (99.6–100) | |
| Symptomatic | Oropharyngeal | 100 7/7 (64.6–100) | 99.7 726/728 (99.0–99.9) | 92.2 47/51 (81.5–96.9) | 99.6 679/682 (98.7–99.9) |
| Rectal | 98.0 48/49 (89.3–99.6) | 99.3 667/672 (98.3–99.7) | 90.9 40/44 (78.8–96.4) | 99.6 675/678 (98.7–99.8) | |
| Unknown | Oropharyngeal | NA | 100 17/17 (81.6–100) | NA | 100 17/17 (81.6–100) |
| Rectal | NA | 100 17/17 (81.6–100) | 100 1/1 (20.7–100) | 100 16/16 (80.6–100) | |
| Total | Oropharyngeal | 100 24/24 (86.2–100) | 99.8 2,269/2,274 (99.5–99.9) | 92.8 90/97 (85.8–96.5) | 99.5 2,194/2,206 (99.1–99.7) |
| Rectal | 97.7 129/132 (93.5–99.2) | 99.4 2,130/2,142 (99.0–99.7) | 95.8 91/95 (89.7–98.4) | 99.8 2,177/2,181 (99.5–99.9) |
NA =Not Available. There were 17 subjects with unknown symptomatic status. Among these subjects, there were no oropharyngeal or rectal samples positive for CT and no oropharyngeal samples positive for GC.
Non-Reportable Results for BD COR™ System for Extragenital Specimens
Non-reportable results were defined as results obtained while assessing the CT/GC targets with the BD CTGCTV2 assay on BD COR™ System which resulted in a sample processing control or system failure. A failure may also occur when the External Control produces an unexpected result such as an External Positive Control that produces a negative result or an External Negative Control that produces a positive result.
Page 21
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 17 of 20
The non-reportable rate calculations were obtained using the specimen tested during the clinical performance study, detailed above. The subject/specimen and the BD CTGCTV2 assay must be compliant to qualify the data included in the calculation for the denominator of the UNR/IND/INC rate. To be considered compliant for non-reportable rate calculations, the specimen must have been collected from a compliant subject, have a compliant reference result per the CCA, been handled within known stability, and had sufficient volume to be run on the BD CTGCTV2 assay. A UNR is counted in the numerator only if it is subject/specimen compliant, BD CTGCTV2 assay compliant, and External Controls yield expected results. External Controls are not considered for IND/INC numerator calculations.
Table 14 through Table 16 provide the unresolved, indeterminate, incomplete, and total rate per target (CT/GC/Combined), stratified by specimen type. The combined rate on initial test across all sample types and combined targets was 0.6%. There were no INC results in any initial test or repeated test in this study.
Page 22
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 18 of 20
Table 14. Unresolved/Indeterminate/Incomplete Rate by CT Target and Specimen Type
| CT | Unresolved Rate | Indeterminate Rate | Incomplete Rate | Total Rate | ||||
|---|---|---|---|---|---|---|---|---|
| Specimen Type | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) |
| Oropharyngealᵇ | 0.4% 9/2,307 (0.2, 0.7) | 0.0% 1/2,306 (0.0, 0.2) | 0.3% 7/2,307 (0.1, 0.6) | 0.0% 0/2,306 (0.0, 0.2) | 0.0% 0/2,307 (0.0, 0.2) | 0.0% 0/2,306 (0.0, 0.2) | 0.7% 16/2,307 (0.4, 1.1) | 0.0% 1/2,306 (0.0, 0.2) |
| Rectalᶜ | 0.2% 5/2,279 (0.1, 0.5) | 0.0% 1/2,278 (0.0, 0.2) | 0.3% 6/2,279 (0.1, 0.6) | 0.0% 0/2,278 (0.0, 0.2) | 0.0% 0/2,279 (0.0, 0.2) | 0.0% 0/2,278 (0.0, 0.2) | 0.5% 11/2,279 (0.3, 0.9) | 0.0% 1/2,278 (0.0, 0.2) |
| Total | 0.3% 14/4,586 (0.2, 0.5) | 0.0% 2/4,584 (0.0, 0.2) | 0.3% 13/4,586 (0.2, 0.5) | 0.0% 0/4,584 (0.0, 0.1) | 0.0% 0/4,586 (0.0, 0.1) | 0.0% 0/4,584 (0.0, 0.1) | 0.6% 27/4,586 (0.4, 0.9) | 0.0% 2/4,584 (0.0, 0.2) |
ᵃ The final rate is calculated with the number of remaining non-reportable events after repeat testing.
ᵇ The denominator in the final non-reportable rate for the oropharyngeal specimen type (and ultimately Total rate) is decreased by one due to a missing BD COR™ System result upon repeat.
ᶜ The denominator in the final non-reportable rate for the rectal specimen type (and ultimately Total rate) is decreased by one due to a missing BD COR™ System result upon repeat.
Unresolved= invalid SPC due to presence of inhibitory substances or reagent failure
Indeterminate= BD COR™ System failure (with Warning or Error Codes)
Incomplete= aborted run or BD COR™ System failure that halts robot operations (with Warning or Error Codes)
Page 23
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 19 of 20
Table 15. Unresolved/Indeterminate/Incomplete Rate by GC Target and Specimen Type
| GC | Unresolved Rate | Indeterminate Rate | Incomplete Rate | Total Rate | ||||
|---|---|---|---|---|---|---|---|---|
| Specimen Type | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) |
| Oropharyngealᵇ | 0.4% 9/2,307 (0.2, 0.7) | 0.0% 1/2,306 (0.0, 0.2) | 0.3% 7/2,307 (0.1, 0.6) | 0.0% 0/2,306 (0.0, 0.2) | 0.0% 0/2,307 (0.0, 0.2) | 0.0% 0/2,306 (0.0, 0.2) | 0.7% 16/2,307 (0.4, 1.1) | 0.0% 1/2,306 (0.0, 0.2) |
| Rectalᶜ | 0.1% 3/2,279 (0.0, 0.4) | 0.0% 1/2,278 (0.0, 0.2) | 0.3% 6/2,279 (0.1, 0.6) | 0.0% 0/2,278 (0.0, 0.2) | 0.0% 0/2,279 (0.0, 0.2) | 0.0% 0/2,278 (0.0, 0.2) | 0.4% 9/2,279 (0.2, 0.7) | 0.0% 1/2,278 (0.0, 0.2) |
| Total | 0.3% 12/4,586 (0.1, 0.5) | 0.0% 2/4,584 (0.0, 0.2) | 0.3% 13/4,586 (0.2, 0.5) | 0.0% 0/4,584 (0.0, 0.1) | 0.0% 0/4,586 (0.0, 0.1) | 0.0% 0/4,584 (0.0, 0.1) | 0.5% 25/4,586 (0.4, 0.8) | 0.0% 2/4,584 (0.0, 0.2) |
ᵃ The final rate is calculated with the number of remaining non-reportable events after repeat testing.
ᵇ The denominator in the final non-reportable rate for the oropharyngeal specimen type (and ultimately Total rate) is decreased by one due to a missing BD COR™ System result upon repeat.
ᶜ The denominator in the final non-reportable rate for the rectal specimen type (and ultimately Total rate) is decreased by one due to a missing BD COR™ System result upon repeat.
Unresolved= invalid SPC due to presence of inhibitory substances or reagent failure
Indeterminate= BD COR™ System failure (with Warning or Error Codes)
Incomplete= aborted run or BD COR™ System failure that halts robot operations (with Warning or Error Codes)
Page 24
BD CTGCTV2 510(k)
BD Diagnostic Systems
Becton, Dickinson and Company
Page 20 of 20
Table 16. Unresolved/Indeterminate/Incomplete Rate for CT and GC by Specimen Type
| Combined Target | Unresolved Rate | Indeterminate Rate | Incomplete Rate | Total Rate | ||||
|---|---|---|---|---|---|---|---|---|
| Specimen Type | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) | Initial (95% CI) | Valid Repeatᵃ (95% CI) |
| Oropharyngealᵇ | 0.4% 9/2,307 (0.2, 0.7) | 0.0% 1/2,306 (0.0, 0.2) | 0.3% 7/2,307 (0.1, 0.6) | 0.0% 0/2,306 (0.0, 0.2) | 0.0% 0/2,307 (0.0, 0.2) | 0.0% 0/2,306 (0.0, 0.2) | 0.7% 16/2,307 (0.4, 1.1) | 0.0% 1/2,306 (0.0, 0.2) |
| Rectalᶜ | 0.2% 5/2,279 (0.1, 0.5) | 0.0% 1/2,278 (0.0, 0.2) | 0.3% 6/2,279 (0.1, 0.6) | 0.0% 0/2,278 (0.0, 0.2) | 0.0% 0/2,279 (0.0, 0.2) | 0.0% 0/2,278 (0.0, 0.2) | 0.5% 11/2,279 (0.3, 0.9) | 0.0% 1/2,278 (0.0, 0.2) |
| Total | 0.3% 14/4,586 (0.2, 0.5) | 0.0% 2/4,584 (0.0, 0.2) | 0.3% 13/4,586 (0.2, 0.5) | 0.0% 0/4,584 (0.0, 0.1) | 0.0% 0/4,586 (0.0, 0.1) | 0.0% 0/4,584 (0.0, 0.1) | 0.6% 27/4,586 (0.4, 0.9) | 0.0% 2/4,584 (0.0, 0.2) |
ᵃ The final rate is calculated with the number of remaining non-reportable events after repeat testing.
ᵇ The denominator in the final non-reportable rate for the oropharyngeal specimen type (and ultimately Total rate) is decreased by one due to a missing BD COR™ System result upon repeat.
ᶜ The denominator in the final non-reportable rate for the rectal specimen type (and ultimately Total rate) is decreased by one due to a missing BD COR™ System result upon repeat.
Unresolved= invalid SPC due to presence of inhibitory substances or reagent failure
Indeterminate= BD COR™ System failure (with Warning or Error Codes)
Incomplete= aborted run or BD COR™ System failure that halts robot operations (with Warning or Error Codes)