(438 days)
No
The summary describes a standard automated molecular diagnostic system using PCR for DNA detection. There is no mention of AI, ML, or any algorithms beyond basic data processing for result interpretation.
No.
The device is used for the qualitative detection of DNA to aid in the diagnosis of certain diseases, making it a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens... and may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens." It further clarifies that "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." This directly indicates its role in diagnosis.
No
The device description clearly outlines a physical system (BD COR System) that performs sample extraction, amplification, and detection, indicating it is a hardware-based medical device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for the "direct, qualitative detection of DNA from: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis (TV)". It also states that the assay is used "to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (vaginal swabs, urine, endocervical swabs, LBC specimens) to provide information for diagnostic purposes.
- Device Description: The description details a system that processes clinical specimens (urine, swabs, LBC) to extract and amplify DNA for detection. This process is performed in vitro.
- Performance Studies: The document includes detailed performance studies (analytical and clinical agreement) that are typical for IVD devices, evaluating metrics like precision, reproducibility, analytical sensitivity, cross-contamination, and clinical agreement (PPA, NPA). These studies are conducted to demonstrate the performance of the device for its intended diagnostic use.
- Predicate Device: The mention of a "Predicate Device" (K182692; BD CTGCTV2 on BD MAX System) which is also an IVD, further supports that this device falls under the IVD category.
All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
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 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 on the BD MAX System or the BD COR System.
Product codes (comma separated list FDA assigned to the subject device)
QEP, OUY, LSL, MKZ
Device Description
As with the existing BD CTGCTV2 for BD MAX System, K182692, the BD COR PX/MX (BD COR) high throughput system conducts sample extraction steps to isolate and concentrate DNA which is then amplified to detect specific sequences for diagnostic purposes.
The BD COR System is designed to allow the user to place clinical specimens directly into designated transport racks to be loaded into the System. Once the specimens are loaded, the System will perform the necessary pre-analytical steps such as vortexing, aliquoting into a molecular tube with the correct diluent, sorting/grouping of the secondary samples for testing by assay, pre-warming and cooling of the sample (where required), and transport of the sample into a molecular analyzer, where extraction, amplification and detection will take place.
Additionally, the steps of ordering tests on the instrument for specific samples will be managed directly by the user interaction with the Laboratory Information System (LIS), which communicates with the instrument.
Once the clinical specimens are received in the laboratory and loaded into the transport racks, the user will not be required to directly handle the specimen again prior to result reporting and removal from the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urogenital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
In vitro diagnostic for prescription use. Samples collected in a clinical setting by patient or clinician.
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
Remnant urine specimens from the previous clinical trial for BD CTGCTV2 on BD MAX as well as urine specimens obtained from both internal and external collections were used for the comparison study. Clinical panels were created either with individual specimens, or negative clinical specimens spiked with a positive clinical specimen. No more than two negative specimens were combined as background negative matrix, and no more than one clinical positive was used per panel. The clinical agreement study included 433 independent panel members. The panels were prepared so that a majority of the positive specimens for CT, GC or TV were at analyte levels of Low Positive and Moderate Positive. Six aliquots were prepared from each panel member. Among them, three aliquots were tested on the BD COR System with two aliquots each being tested at an external site and the third aliquot being tested at an internal site. The other three aliquots were all tested internally with each aliquot being tested on a separate BD MAXTM System.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance: Analytical performance of the BD CTGCTV2 assay was evaluated on the BD MAX System and the results may be found under K182692. As the formulation of the BD CTGCTV2 assay reagents for use on the BD COR System has not changed from those used with the BD MAX System, certain analytical studies performed and documented in the package insert on BD MAX can be leveraged for and are applicable to the BD COR System (specimen stability, analytical sensitivity, inclusivity, cross-reactivity, and interfering substances). The following sections describe the analytical studies that were performed to demonstrate that the assay performance, when used on BD COR, is unchanged from the performance demonstrated on the BD MAX System. The new analytical studies included: within-laboratory precision and multi-site reproducibility, confirmation of the analytical sensitivity and a cross-contamination study, all performed on the BD COR System.
Precision Study:
Within-laboratory precision was evaluated for the BD CTGCTV2 assay on the BD COR System at one site with one reagent lot. Testing was performed over 12 days, with 3 runs per day (2 technologists, 6 days per technologist), for a total of 36 runs. Test samples were contrived in female urine, and in PreservCytLBC specimen matrix and included Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis (urine only) panel member was tested in two replicates.
Key Results: For PreservCyt samples, percent agreement with expected results ranged from 38.9% to 100%. For urine samples, percent agreement with expected results ranged from 37.5% to 100%.
Reproducibility Study:
For the Site-to-Site reproducibility study, three (3) sites (2 external and one internal) were provided the same panels as described for the Precision study, above. Each site performed testing on 6 distinct days (consecutive or not), wherein three (3) panels were tested by each of two (2) technologists (3 days per technologist) with one lot of reagents.
Key Results: The overall PreservCyt site-to-site reproducibility percent agreement was 100% for TN and ranged from 38.9% to 48.1% for HN, 91.7% to 98.1% for LP and 98.1% to 100% MP categories. The overall (across sites) Urine site-to-site reproducibility percent agreement was 100% for TN, LP and MP and ranged from 37.0% to 58.3% for HN categories.
Analytical Sensitivity Confirmation Study:
The analytical sensitivity/Limit of Detection (LoD) of the BD CTGCTV2 assay in urine, vaginal swab and PreservCyt LBC specimen matrix on the BD COR System was confirmed to be equivalent to that of the BD MAX System.
Key Results: Results from this study demonstrate that the analytical sensitivity (LoD) of the BD CTGCTV2 assay in vaginal, urine and PreservCyt LBC samples on BD COR is equivalent to the analytical sensitivity (LoD) demonstrated on the BD MAX.
Cross-Contamination Study:
A study was conducted to investigate cross-contamination while processing samples with high microbial load of Chlamydia trachomatis in the BD CTGCTV2 assay.
Key Results: Of the 540 negative samples tested, two false positive results were obtained (0.37%, 95% CI: 0.10-1.34%).
Clinical Agreement Study:
The clinical performance of the BD CTGCTV2 assay was established based on the data from BD MAX. For the purpose of demonstrating that use of the assay with the BD COR doesn't compromise the safety and effectiveness of the assay, clinical comparison studies were performed on both the BD MAX and BD COR Systems. The performance of the BD CTGCTV2 assay on the BD COR was evaluated in a clinical agreement study by comparing the assay results obtained on the BD COR System to the results obtained on the BD MAX System. BD MAX results served as reference in the clinical agreement study.
To demonstrate that the performance of the BD CTGCTV2 assay on the BD COR System is equivalent to the performance of BD MAX, both positive/negative percent agreement analysis and Deming regression analysis of the Ct.Score values were performed.
Key Results:
For CT: Average PPA: 100%, Average NPA: 100%.
For GC: Average PPA: 97.6%, Average NPA: 100%.
For TV: Average PPA: 99.7%, Average NPA: 98.5%.
The systematic differences in numeric value between Ct.Score results from BD COR and BD MAX were evaluated by the Weighted Deming regression analysis.
Non-Reportable Results Study:
Non-reportable results on the BD COR are reported in the same manner as on the BD MAX and the definitions of all possible Non-reportable events are summarized in Table 21. Error results on the BD COR System were marked noncompliant if they were due to an operator error and were not included in the Non-reportable rate calculation.
Key Results: The total initial non-reportable rate for combined targets across all sites was 2.4% (31/1298) (95% CI: 1.7%, 3.4%). The final non-reportable rate was 0.0% (0/1297) (95% CI: 0.0%, 0.3%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision Study:
- PreservCyt CT: MP 100% (72/72), LP 98.6% (71/72), HN 38.9% (28/72), TN 100% (72/72)
- PreservCyt GC: MP 95.8% (69/72), LP 93.1% (67/72), HN 43.1% (31/72), TN 100% (72/72)
- Urine CT: MP 100% (72/72), LP 100% (72/72), HN 54.2% (39/72), TN 100% (72/72)
- Urine GC: MP 98.6% (71/72), LP 100% (72/72), HN 44.4% (32/72), TN 100% (72/72)
- Urine TV: MP 100% (72/72), LP 100% (72/72), HN 37.5% (27/72), TN 100% (72/72)
Reproducibility Study (Percent Agreement with Expected Results for Site to Site):
- PreservCyt CT: MP 100% (Overall 108/108), LP 98.1% (Overall 106/108), HN 48.1% (Overall 52/108), TN 100% (Overall 108/108)
- PreservCyt GC: MP 98.1% (Overall 106/108), LP 91.7% (Overall 99/108), HN 38.9% (Overall 42/108), TN 100% (Overall 108/108)
- Urine CT: MP 100% (Overall 108/108), LP 100% (Overall 108/108), HN 58.3% (Overall 63/108), TN 100% (Overall 108/108)
- Urine GC: MP 100% (Overall 108/108), LP 100% (Overall 108/108), HN 41.7% (Overall 45/108), TN 100% (Overall 108/108)
- Urine TV: MP 100% (Overall 108/108), LP 100% (Overall 108/108), HN 37.0% (Overall 40/108), TN 100% (Overall 108/108)
Clinical Agreement Study (Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of BD COR versus BD MAX Result):
- CT:
- Site 1: PPA: 100.0% (105/105), NPA: 100.0% (108/108)
- Site 2: PPA: 100.0% (106/106), NPA: 100.0% (108/108)
- Site 3: PPA: 100.0% (106/106), NPA: 100.0% (108/108)
- Average PPA: 100%, Average NPA: 100%
- GC:
- Site 1: PPA: 99.1% (110/111), NPA: 100.0% (107/107)
- Site 2: PPA: 98.2% (108/110), NPA: 100.0% (107/107)
- Site 3: PPA: 95.5% (106/111), NPA: 100.0% (107/107)
- Average PPA: 97.6%, Average NPA: 100%
- TV:
- Site 1: PPA: 100.0% (105/105), NPA: 99.1% (109/110)
- Site 2: PPA: 100.0% (105/105), NPA: 97.3% (107/110)
- Site 3: PPA: 99.0% (104/105), NPA: 99.1% (109/110)
- Average PPA: 99.7%, Average NPA: 98.5%
Non-Reportable Rate:
- Total: 2.4% (31/1298) at Initial. 0.0% (0/1297) at Final.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BD CTGCTV2 on BD MAX System (K182692)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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May 10, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
Becton Dickinson and Company Jessica Dewyer Senior Manager, Regulatory Affairs 7 Loveton Circle Sparks, Maryland 21152
Re: K210585
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, OUY, LSL, MKZ Dated: February 25, 2021 Received: February 26, 2021
Dear Jessica Dewyer:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Himani Bisht, Ph.D. Assistant Director Viral Respiratory and HPV Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below. |
| ------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number (if known) | K210585 |
|---|---|
| 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 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 on the BD MAX System or the BD COR System.
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
" 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 (6/20)
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510(k) Summary
BD CTGCTV2 on BD COR System K210585
Summary Preparation Date:
4/27/2022
Submitted by:
BD Integrated Diagnostic Solutions Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Contact:
Jessica Dewyer, Senior Manager, Regulatory Affairs Becton Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA (520) 486-8516 Jessica.dewyer@bd.com
Proprietary Names:
For the instrument: BD COR PX/MX System For the assay: BD CTGCTV2
Common Names:
For the instrument: High-throughput molecular system
For the assay: CT, GC and TV assay
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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 (83)
Product Code(s): QEP MKZ LSL OUY
Predicate Device
BD CTGCTV2 on BD MAX System (K182692)
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 is indicated for use with asymptomatic 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.
Special Conditions for Use Statement: For Prescription Use Only
Special Instrument Requirements: BD COR PX/MX System
Device Description
As with the existing BD CTGCTV2 for BD MAX System, K182692, the BD COR PX/MX (BD COR) high throughput system conducts sample extraction steps to isolate and concentrate DNA which is then amplified to detect specific sequences for diagnostic purposes.
The BD COR System is designed to allow the user to place clinical specimens directly into designated transport racks to be loaded into the System. Once the specimens are loaded, the System will perform the necessary pre-analytical steps such as vortexing, aliquoting into a molecular tube with the correct diluent, sorting/grouping of the secondary samples for testing by assay, pre-warming and
5
cooling of the sample (where required), and transport of the sample into a molecular analyzer, where extraction, amplification and detection will take place.
Additionally, the steps of ordering tests on the instrument for specific samples will be managed directly by the user interaction with the Laboratory Information System (LIS), which communicates with the instrument.
Once the clinical specimens are received in the laboratory and loaded into the transport racks, the user will not be required to directly handle the specimen again prior to result reporting and removal from the system.
Test Principle
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, 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 MX, 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 PX/MX System dispenses a fixed volume of PCR-ready solution contaming extracted nucleic acids into the BD PCR Cartridge.
Microvalves in the BD 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 PX/MX 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
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result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The BD COR PX/MX 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 assay and the predicate device.
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 which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this 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 aganst interest under the US Patent Laws or the courts.
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| Items | BD CTGCTV2 | BD CTGCTV2 for BD MAX System |
|---|---|---|
| 510(k)# | K210585 | K182692 |
| Regulation | 866.3393, 866.3120, 866.3390, 866.3860 | 866.3120, 866.3390, 866.3860 |
| Product Code | QEP, MKZ, LSL, OUY | MKZ, LSL, OUY |
| 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 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. | The BD CTGCTV2 for BD MAXTM System, | |
| performed on the BD MAXTM 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 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. | ||
| Indications | ||
| for Use | Same | Asymptomatic and Symptomatic Patients |
| Specimen Type | Same | Clinician-collected vaginal swab, patient collected |
| vaginal swab, endocervical swab, | ||
| PreservCyt LBC, female and male urine | ||
| Technology | Same | PCR |
| Organisms Detected | Same | CT, GC, and TV |
| DNA extraction, | ||
| amplification and | ||
| detection | Automated by BD COR System | Automated by BD MAX System |
| Assay Controls | Same | Sample Processing Control |
Table 1: Comparison to the Predicate Device
Analytical Performance
Analytical performance of the BD CTGCTV2 assay was evaluated on the BD MAX System and the results may be found under K182692. As the formulation of the BD CTGCTV2 assay reagents for use on the BD COR System has not changed from those used with the BD MAX System, certain analytical studies performed and documented in the package insert on BD MAX can be leveraged for and are applicable to the BD COR System (specimen stability, analytical sensitivity, inclusivity, cross-reactivity,
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and interfering substances). The following sections describe the analytical studies that were performed to demonstrate that the assay performance, when used on BD COR, is unchanged from the performance demonstrated on the BD MAX System. The new analytical studies included: within-laboratory precision and multi-site reproducibility, confirmation of the analytical sensitivity and a cross-contamination study, all performed on the BD COR System.
Precision for BD COR System
Within-laboratory precision was evaluated for the BD CTGCTV2 assay on the BD COR System at one site with one reagent lot. Testing was performed over 12 days, with 3 runs per day (2 technologists, 6 days per technologist), for a total of 36 runs. Test samples were contrived in female urine, and in PreservCytLBC specimen matrix and included Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis (urine only) panel member was tested in two replicates. 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):