(90 days)
No
The summary describes a real-time PCR-based diagnostic test and an automated system for sample processing and analysis. There is no mention of AI or ML being used for data analysis, interpretation, or any other part of the process. The analysis relies on detecting specific DNA targets and reporting qualitative results based on their presence and quantitation.
No
The device is described as an in vitro diagnostic test for the detection of DNA targets to aid in the diagnosis of vaginal infections, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis...Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs." It further clarifies that the "BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections."
No
The device is an in vitro diagnostic test that utilizes a physical system (BD COR™ System or BD MAX™ System) for sample processing, extraction, amplification, and detection. While software is involved in controlling the system and potentially processing results, the core functionality relies on hardware components and chemical reagents.
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 BD Vaginal Panel is an "automated qualitative in vitro diagnostic test".
- Purpose: The test is designed for the "direct detection of DNA targets from bacteria associated with bacterial vaginosis, Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginosis." This is a diagnostic purpose performed outside of the body (in vitro).
- Method: The test utilizes "real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA". These are standard in vitro diagnostic techniques.
- Aid in Diagnosis: The intended use also states that the test is "intended to aid in the diagnosis of vaginal infections". This clearly indicates a diagnostic purpose.
- Sample Type: The test is performed on "vaginal swabs", which are biological specimens collected from the patient for in vitro analysis.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
- · Bacterial vaginosis markers (Individual markers not reported) Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1
- · Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
- · Candida glabrata
- Candida krusei
- Trichomonas vaginalis
The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.
Product codes (comma separated list FDA assigned to the subject device)
PQA, OUY, OOI, NSU
Device Description
As with the existing BD Vaginal Panel for use with the BD MAX™ System (K201017), 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 drectly 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 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
vaginal
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
Precision Study:
Sample Size: Total of 48 runs (2 runs per day, 2 replicates per panel member over 12 days).
Data Source: Panel members made of target organisms (or plasmid DNA for Megasphaera-1 and BVAB-2) spiked in simulated vaginal matrix.
Annotation Protocol: Bacterial vaginosis panel members prepared at varying concentrations to generate low positive, moderate positive, high negative, or negative results. For Candida and Trichomonas vaginalis, target organisms spiked at concentrations based on assay LoD. Qualitative and quantitative precision results (Second Derivative Peak Abscissa (SDPA), SD, and %CV) were analyzed.
Reproducibility Study:
Sample Size: Testing performed at 3 sites (2 external, 1 internal) over 8 days. At each site, 2 operators performed 2 runs on alternate days, for a total of 48 runs.
Data Source: Same sample categories as defined for the precision study, which are spiked samples in simulated vaginal matrix.
Annotation Protocol: Qualitative and quantitative reproducibility results (Second Derivative Peak Abscissa (SDPA), SD, and %CV) were analyzed across sites and by target.
Analytical Sensitivity Confirmation:
Sample Size: 20 panels.
Data Source: Panels created using LoD previously determined on the BD MAX™ System, with samples prepared by spiking representative vaginosis target and/or vaginitis target in the presence of simulated vaginal matrix (SVM).
Annotation Protocol: A Two, One-Sided Test (TOST) of Equivalence was performed for low positive (1.99x LoD) and moderate positive (5x LoD) target levels. Equivalence established when 90% confidence intervals for the difference in mean Ct.score were within the equivalence margin of [-6% of the reference mean, +6% of the reference mean]. For High Negative (C5) Candida spp. panel members, equivalence was demonstrated by overlapping 95% confidence intervals an SDPA values.
Cross-Contamination Study:
Sample Size: 543 negative samples tested.
Data Source: Alternating high positive and negative members. High positive panel members consisted of L. jensenii, G. vaginalis, A. vaginae, BVAB-2, and T. vaginalis. Negative members contained no target analytes.
Annotation Protocol: Contamination rate was calculated and compared against predefined study acceptance criteria.
Clinical Agreement Study:
Sample Size: 700 panel members.
Data Source: Clinical vaginal specimens obtained from internal collections, pooled previously collected clinical specimens, and contrived samples created by spiking organisms into simulated matrix or negative vaginal matrix.
Annotation Protocol: Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were calculated between BD COR™ and BD MAX™ Systems (BD MAX™ served as reference). Weighted Deming regression analysis was performed on Ct.Score or SDPA values.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance Studies:
-
Precision for BD COR™ System:
- Study Type: Within-laboratory precision study.
- Sample Size: 1 site, 1 reagent lot, 12 days, 2 runs/day, 2 replicates/panel, total 48 runs.
- Key Results: Qualitative and quantitative precision results for BD COR™ System showed high correctness rates (100% for most true negatives, BV negative, low positive, and moderate positive levels for all targets). For BV high negative, correctness was 79.7% on BD COR™ and 87.5% on BD MAX™. Quantitative precision (SDPA) showed low %CV values, indicating high precision.
-
Reproducibility for BD COR™ System:
- Study Type: Multi-site reproducibility study.
- Sample Size: 3 sites (2 external, 1 internal), 8 days, 2 operators/site, 2 runs on alternate days/operator, total 48 runs.
- Key Results: Qualitative reproducibility showed 100% correctness for most negative and positive levels across sites for BD COR™ and BD MAX™. For BV high negative, overall correctness was 72.9% for BD COR™ and 75.0% for BD MAX™. Quantitative reproducibility (SDPA) also showed low %CV values for all vaginitis targets and sites.
-
Analytical Sensitivity Confirmation for BD COR™ System:
- Study Type: Limit of Detection (LoD) confirmation study using equivalence testing.
- Sample Size: 20 panels.
- Key Results: Equivalence was established between BD COR™ and BD MAX™ systems for all vaginosis and vaginitis targets at low and moderate positive levels, as the 90% CI for the difference in mean Ct.Score was within the defined equivalence interval. For high negative Candida spp., overlapping 95% CI indicated equivalence.
-
Cross-Contamination for BD COR™ System:
- Study Type: Cross-contamination study.
- Sample Size: 543 negative samples.
- Key Results: 1 false positive result was observed, demonstrating a contamination rate of 0.18% (95% CI: 0.03-1.04%), which met predefined study acceptance criteria.
Clinical Agreement Study:
- Clinical Agreement Study between BD MAX™ and BD COR™ Systems:
- Study Type: Comparison study.
- Sample Size: 700 panel members.
- Key Results:
- BV Contrived Specimens: Average PPA: 99.5% (95% CI: 98.4, 100), Average NPA: 100% (95% CI: N/A), Average OPA: 99.8% (95% CI: 99.3, 100).
- BV Natural Specimens: Average PPA: 97.8% (95% CI: 96.3, 99.1), Average NPA: 95.8% (95% CI: 93.1, 98.2), Average OPA: 97.2% (95% CI: 95.8, 98.4).
- C. glabrata: Average PPA: 100% (95% CI: N/A), Average NPA: 100% (95% CI: N/A), Average OPA: 100% (95% CI: N/A).
- C. krusei: Average PPA: 100% (95% CI: N/A), Average NPA: 100% (95% CI: N/A), Average OPA: 100% (95% CI: N/A).
- Candida Group: Average PPA: 99.4% (95% CI: 98.5, 100), Average NPA: 98.9% (95% CI: 97.4, 100), Average OPA: 99.2% (95% CI: 98.3, 99.9).
- TV (Trichomonas vaginalis): Average PPA: 99.7% (95% CI: 99.0, 100), Average NPA: 100% (95% CI: N/A), Average OPA: 99.9% (95% CI: 99.5, 100).
- Deming Regression analysis showed strong correlations (Pearson's r = 0.708 for C. glabrata, 0.938 for Cgroup, 0.881 for C. krusei, 0.962 for TV) between BD COR™ and BD MAX™ Ct.Score/SDPA results, indicating good agreement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Agreement Study Metrics:
- BV Contrived Specimens:
- Average PPA: 99.5%; Bootstrap 95% CI: (98.4, 100)
- Average NPA: 100%; Bootstrap 95% CI: N/A
- Average OPA: 99.8%; Bootstrap 95% CI: (99.3, 100)
- BV Natural Specimens:
- Average PPA: 97.8%; Bootstrap 95% CI: (96.3, 99.1)
- Average NPA: 95.8%; Bootstrap 95% CI: (93.1, 98.2)
- Average OPA: 97.2%; Bootstrap 95% CI: (95.8, 98.4)
- C. glabrata:
- Average PPA: 100%; Bootstrap 95% CI: N/A
- Average NPA: 100%; Bootstrap 95% CI: N/A
- Average OPA: 100%; Bootstrap 95% CI: N/A
- C. krusei:
- Average PPA: 100%; Bootstrap 95% CI: N/A
- Average NPA: 100%; Bootstrap 95% CI: N/A
- Average OPA: 100%; Bootstrap 95% CI: N/A
- Candida Group:
- Average PPA: 99.4%; Bootstrap 95% CI: (98.5, 100)
- Average NPA: 98.9%; Bootstrap 95% CI: (97.4, 100)
- Average OPA: 99.2%; Bootstrap 95% CI: (98.3, 99.9)
- TV:
- Average PPA: 99.7%; Bootstrap 95% CI: (99.0, 100)
- Average NPA: 100%; Bootstrap 95% CI: N/A
- Average OPA: 99.9%; Bootstrap 95% CI: (99.5, 100)
Cross-Contamination Rate:
- 0.18% (95% CI: 0.03-1.04%) for false positive results.
Non-Reportable Rate for BD COR™ System (Combined Target, Final after repeat testing):
- Site 1: 0.0% (0/681) (0.0, 0.6)
- Site 2: 0.0% (0/683) (0.0, 0.6)
- Site 3: 0.0% (0/680) (0.0, 0.6)
- Overall: 0.0% (0/2044) (0.0, 0.2)
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 MAX Vaginal Panel (DEN160001, K191957, K201017)
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
N/A
0
March 6, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Becton, Dickinson and Company Joseph Basore Staff Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152
Re: K223653
Trade/Device Name: BD Vaginal Panel Regulation Number: 21 CFR 866.3975 Regulation Name: Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis And Bacterial Vaginosis Regulatory Class: Class II Product Code: PQA, OUY, OOI, NSU Dated: December 5, 2022 Received: December 6, 2022
Dear Joseph Basore:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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,
Noel J. Gerald -S
Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223653
Device Name BD Vaginal Panel
Indications for Use (Describe)
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
- · Bacterial vaginosis markers (Individual markers not reported) Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1
- · Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
- · Candida glabrata
- Candida krusei
- Trichomonas vaginalis
The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.
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) |
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3
510(k) Summary
BD Vaginal Panel
Summary Preparation Date:
12/5/2022
Submitted by:
BD Integrated Diagnostic Solutions Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Contact:
Joseph Basore, Ph.D., RAC Staff Regulatory Affairs Specialist Tel: 616-301-4068 Email: Joseph.Basore@bd.com
Proprietary Names:
For the instrument: BD COR™ PX/MX System
For the assay: BD Vaginal Panel
Common Names:
For the instrument: High-throughput molecular system
For the assay: Bacterial Vaginosis Assay Vaginitis Assay TV Assay Candida Assay
Regulatory Information
Regulation section: 21 CFR 866.3975 – Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis
Classification: Class II (Special Controls)
Panel: Microbiology (83)
Product Code(s):
4
Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System PQA OUY Trichomonas vaginalis Nucleic Acid Amplification Test System
- OOI Real Time Nucleic Acid Amplification System
- Instrumentation for Clinical Multiplex Test Systems NSU
Predicate Device
BD MAX Vaginal Panel (DEN160001, K191957, K201017)
Device Establishment
Registration Number: 1119779
Intended Use
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
- · Bacterial vaginosis markers (Individual markers not reported) Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1
- Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
- · Candida glabrata
- Candida krusei
- Trichomonas vaginalis
The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
The BD Vaginal Panel 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 CORTM PX/MX System
Device Description
As with the existing BD Vaginal Panel for use with the BD MAX™ System (K201017), 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
CONFIDENTIAL AND PROPRIETARY
5
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 drectly 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 reporting and removal from the system.
Test Principle
The BD Vaginal Panel when performed on the BD CORTM System is designed for use with the BD Molecular Swab Collection kit. Samples are transported to the testing laboratory in BD Molecular Swab Sample Buffer Tubes. The BD COR™ MX Instrument, when combined with the BD COR™ PX Instrument, is to be used for automated sample preparation, extraction of nucleic acids from multiple specimen types, as well as the automated amplification of target nucleic acid sequences by fluorescence-based real-time PCR.
The BD Vaginal Panel extraction reagents are dried in 96-well microtiter plates that contain binding magnetic affinity beads and Sample Processing Control (SPC). Each well 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 Vaginal Panel 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. 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 containing 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 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 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 vaginitis analyte as well as qualitative results for bacterial vaginosis based on detection and quantitation of targeted bacterial vaginosis markers.
Substantial Equivalence1
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 ther application by the courts.
6
Table 3 provides the similarities and differences between the submitted device and the legally marketed predicate device.
| Table 1: Comparison to Predicate Device |
|---|
| ----------------------------------------- |
| Items | BD Vaginal Panel | Predicate - BD MAXTM Vaginal Panel,
BD MAXTM System (K201017) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | Same | 866.3975 |
| Product Code | Same | PQA, OUY, OOI, NSU |
| Device Class | Same | II |
| Intended Use | The BD Vaginal Panel is an automated
qualitative in vitro diagnostic test for the
direct detection of DNA targets from
bacteria associated with bacterial
vaginosis (qualitative results reported
based on detection and quantitation of
targeted organism markers), Candida
species associated with vulvovaginal
candidiasis, and Trichomonas vaginalis
from vaginal swabs in patients who are
symptomatic for vaginitis/vaginosis. The
test utilizes real-time polymerase chain
reaction (PCR) for the amplification of
specific DNA targets and utilizes
fluorogenic target-specific hybridization
probes to detect and differentiate DNA
from: Bacterial vaginosis markers
(Individual markers not
reported) Lactobacillus spp. ( L.
crispatus and L. jensenii ) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis
Associated Bacteria-2
(BVAB-2) Megasphaera-1 Candida spp. ( C. albicans, C.
tropicalis, C. parapsilosis, C.
dubliniensis ) Candida glabrata Candida krusei Trichomonas vaginalis The BD Vaginal Panel is intended to aid
in the diagnosis of vaginal infections in | The BD MAX Vaginal Panel performed
on the BD MAX System is an automated
qualitative in vitro diagnostic test for the
direct detection of DNA targets from
bacteria associated with bacterial
vaginosis (qualitative results reported
based on detection and quantitation of
targeted organism markers), Candida
species associated with vulvovaginal
candidiasis, and Trichomonas vaginalis
from vaginal swabs in patients who are
symptomatic for vaginitis/vaginosis. The
test utilizes real-time polymerase chain
reaction (PCR) for the amplification of
specific DNA targets and utilizes
fluorogenic target-specific hybridization
probes to detect and differentiate DNA
from: Bacterial vaginosis markers
(Individual markers not
reported) Lactobacillus spp. ( L.
crispatus and L. jensenii ) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis
Associated Bacteria-2
(BVAB-2) Megasphaera-1 Candida spp. ( C. albicans, C.
tropicalis, C. parapsilosis, C.
dubliniensis ) Candida glabrata Candida krusei Trichomonas vaginalis |
| Items | BD Vaginal Panel | Predicate - BD MAXTM Vaginal Panel,
BD MAXTM System (K201017) |
| | women with a clinical presentation
consistent with bacterial vaginosis,
vulvovaginal candidiasis and
trichomoniasis.
The BD Vaginal Panel is available for
use with the BD MAXTM System or the
BD CORTM System. | The BD MAX Vaginal Panel is intended
to aid in the diagnosis of vaginal
infections in women with a clinical
presentation consistent with bacterial
vaginosis, vulvovaginal candidiasis and
trichomoniasis. |
| Indications for Use | Same | Symptomatic patients |
| Specimen Type | Same | Clinician and patient-collected female
vaginal swab |
| Collection/ Transport
Device | BD Molecular Swab Collection Kit | BD MAX UVE Specimen Collection Kit
BD Molecular Swab Collection Kit |
| Technology | Same | PCR |
| Organisms Detected | Same | Lactobacillus spp. (L. crispatus
and L.jensenii) Gardnerella vaginalis Atopobium vaginae Bacterial Vaginosis Associated
Bacteria-2 (BVAB-2) Megasphaera-1 Candida spp. (C. albicans, C.
tropicalis, C. parapsilosis, C.
dubliniensis) Candida glabrata Candida krusei Trichomonas vaginalis |
| Sample Prep/Results | Automated by BD CORTM System | Partially Automated by BD MAXTM
System |
7
Analytical Performance
Analytical performance of the BD Vaginal Panel was evaluated on the BD MAX™ System and the results may be found under DEN160001 with updates described in subsequent submissions K191957 and K201017. As the formulation of the BD Vaginal Panel 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™ are equally 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
CONFIDENTIAL AND PROPRIETARY
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the BD COR™ System, 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
The precision of the BD Vaginal Panel on the BD COR™ System was confirmed to be equivalent to that of the BD MAX™ System. Within-laboratory precision was evaluated for the BD Vaginal Panel on both the BD MAX™ System and the BD COR™ System at one site with one reagent lot. Testing was performed over twelve (12) days, two (2) runs per day, two (2) replicates per panel, for a total of 48 runs. Panel members were made of target organisms (or plasmid DNA for Megasphaera-1 and BVAB-2) spiked in simulated vaginal matrix. Bacterial vaginosis panel members were prepared at varying concentrations of multiple targeted species with sample compositions designed to generate low positive, moderate positive, high negative, or negative results for bacterial vaginosis. For Candida and Trichomonas vaginalis panel members, the target organisms were spiked at concentrations based on the assay LoD. Table 4 describes the panel members evaluated.
The qualitative and quantitative precision results for BD COR™ System are presented in Table 5. Second Derivative Peak Abscissa (SDPA), an internal criterion used to determine a final assay result, was selected as a means of assessing quantitative assay reproducibility. Mean SDPA values with variance components (SD and % CV) are shown in Table 6 and Table 7.
| Concentration Designation | Bacterial Vaginosis
(% of positive results expected
based on the organism composition) | Candida and Trichomonas vaginalis
(x LoD) |
|---------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------|
| Moderate
Positive | ~100 | ≥2 to ≤5 |
| Low Positive | ~95 | Trichomonas vaginalis | Low Positive | 1 | 32 | 32 | 100 | 89.3 | 100 | 32 | 100 | 89.3 | 100 |
| | | 2 | 32 | 32 | 100 | 89.3 | 100 | 32 | 100 | 89.3 | 100 |
| | | 3 | 32 | 32 | 100 | 89.3 | 100 | 32 | 100 | 89.3 | 100 |
| | | Overall | 96 | 96 | 100 | 96.2 | 100 | 96 | 100 | 96.2 | 100 |
| | Moderate Positive | 1 | 32 | 32 | 100 | 89.3 | 100 | 32 | 100 | 89.3 | 100 |
| | | 2 | 32 | 32 | 100 | 89.3 | 100 | 32 | 100 | 89.3 | 100 |
| | | 3 | 32 | 32 | 100 | 89.3 | 100 | 32 | 100 | 89.3 | 100 |
| | | Overall | 96 | 96 | 100 | 96.2 | 100 | 96 | 100 | 96.2 | 100 |
Table 6: Qualitative Reproducibility by Target and Site for BD COR™ System and BD MAX™ System
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a For the True Negative and BV Negative levels, the reported agreement indicates the percent of negative results.
b For the BV High Negative category, the reported agreement indicates the percent of positive results.
© Performance includes results from replicates of a single panel member.
d Performance includes combined results from replicates of two panel members containing different organism compositions.
Table 7: Quantitative Reproducibility Site-to-Site Summary by Vaginitis Target for BD COR™ System
| | | | | Within Run
(Residual) | | Between Run | | Between Day | | Between
Site | | | Total |
|---------------------|----------------------|----|-------|--------------------------|------|-------------|------|-------------|------|-----------------|------|------|-------|
| Target | Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Candida
glabrata | Low Positive | 96 | 30.30 | 0.53 | 1.76 | 0 | 0 | 0 | 0 | 0.26 | 0.87 | 0.59 | 1.96 |
| Candida krusei | Low Positive | 96 | 28.93 | 0.20 | 0.71 | 0.07 | 0.23 | 0 | 0 | 0 | 0 | 0.22 | 0.74 |
| Candida | Low Positive | 96 | 26.69 | 0.38 | 1.44 | 0 | 0 | 0.16 | 0.59 | 0.07 | 0.25 | 0.42 | 1.57 |
| albicans | Moderate
Positive | 96 | 26.08 | 0.30 | 1.14 | 0.04 | 0.17 | 0.06 | 0.24 | 0.12 | 0.48 | 0.33 | 1.27 |
| Trichomonas | Low Positive | 96 | 32.85 | 0.38 | 1.17 | 0 | 0 | 0 | 0 | 0.15 | 0.45 | 0.41 | 1.25 |
| vaginalis | Moderate
Positive | 96 | 31.66 | 0.30 | 0.93 | 0 | 0 | 0.04 | 0.13 | 0 | 0 | 0.30 | 0.94 |
13
| | | | | Within Run
(Residual) | | Between Run | | Between Day | | Between
Site | | Total | |
|--------------------------|----------------------|----|-------|--------------------------|------|-------------|------|-------------|------|-----------------|------|-------|------|
| Target | Level | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Candida
glabrata | Low Positive | 96 | 30.95 | 0.71 | 2.28 | 0 | 0 | 0.20 | 0.64 | 0.51 | 1.66 | 0.89 | 2.89 |
| Candida krusei | Low Positive | 96 | 29.09 | 0.42 | 1.44 | 0.15 | 0.53 | 0 | 0 | 0 | 0 | 0.45 | 1.54 |
| Candida albicans | Low Positive | 96 | 27.34 | 0.42 | 1.55 | 0.20 | 0.72 | 0 | 0 | 0 | 0 | 0.47 | 1.71 |
| | Moderate
Positive | 96 | 26.49 | 0.42 | 1.59 | 0 | 0 | 0.05 | 0.18 | 0 | 0 | 0.43 | 1.60 |
| Trichomonas
vaginalis | Low Positive | 96 | 32.73 | 0.46 | 1.40 | 0 | 0 | 0.21 | 0.65 | 0.24 | 0.73 | 0.56 | 1.71 |
| | Moderate
Positive | 96 | 31.69 | 0.42 | 1.31 | 0 | 0 | 0 | 0 | 0.08 | 0.25 | 0.42 | 1.34 |
Table 8: Quantitative Reproducibility Site-to-Site Summary by Vaginitis Target for BD MAX™ System
Quality Controls
External Control materials are not provided by BD; however, Quality Control procedures are included in the package insert. Various types of External Controls are recommended to allow the user to select the most appropriate for their laboratory quality control program:
- Commercially available positive control materials ●
- Trichomonas vaginalis (ATCC 30001) ●
- . Candida albicans (ATCC 10231)
- Candida glabrata (ATCC 2001) ●
- . Candida krusei (ATCC 6258)
The assay includes a Specimen Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances.
Analytical Sensitivity Confirmation for BD COR™ System
The analytical sensitivity/Limit of Detection (LoD) of the BD Vaginal Panel on the BD COR™ System was confirmed to be equivalent to that of the BD MAX System with use of the BD Molecular Swab Collection Kit. The study design included using 20 panels of Vaginosis and/or Vaginitis targets at varying concentration levels created using the LoD previously determined on the BD MAX™ System at the target levels identified in Table 11. Samples were prepared by spiking of representative vaginosis target and/or vaginitis target in the presence of simulated vaginal matrix (SVM). Testing was conducted over more than 3 days using qualified BD Vaginal Panel reagents and included two BD COR™ PX/MX Systems and four BD MAX™ Systems.
A Two, One-Sided Test (TOST) of Equivalence was performed for the low positive (1.99x LoD) and moderate positive (5x LoD) target levels for each strain. The 90% confidence intervals for the difference in mean Ct.score between the BD COR™ System and BD MAX™ Systems were determined for each strain at each target level. Equivalence of the two systems is established when it is contained within the equivalence margin of [-6% of the reference mean, +6% of the reference mean]. TOST analysis was not performed on High Negative (C5) Candida spp. panel members based on the proportion positivity being less than 95% at C5, a predicate requirement. SDPA and 95% confidence intervals were
14
generated. Equivalence between the BD COR™ System and BD MAX™ Systems is demonstrated at the High Negative level by overlapping 95% confidence intervals.
Results from the study demonstrate that the analytical sensitivity of the BD Vaginal Panel on BD COR™ is equivalent to the analytical sensitivity (LoD) demonstrated on the BD MAX™ System as shown in Table 12 and Table 13.
| Low Positive (1.99x C95) | Moderate Positive (5x C95) | High Negative (C5) | ||||||
|---|---|---|---|---|---|---|---|---|
| Panel | Target | Concentration | Panel | Target | Concentration | Panel | Target | Concentration |
| 1 | Cgla | 402 CFU/mL | 8 | Cgla | 1010 CFU/mL | 15 | Cgla | 10 CFU/mL |
| 2 | GV | 1914 CFU/mL | 9 | GV | 4810 CFU/mL | 16 | Ckru | 6 CFU/mL |
| 2 | Ckru | 2060 CFU/mL | 9 | Ckru | 5175 CFU/mL | 16 | Ckru | 6 CFU/mL |
| 3 | BVAB | 923 Copies/mL | 10 | BVAB | 2320 Copies/mL | 17 | Calb | 53 CFU/mL |
| 3 | Calb | 35396 CFU/mL | 10 | Calb | 88935 CFU/mL | 17 | Calb | 53 CFU/mL |
| 4 | Mega | 4507 Copies/mL | 11 | Mega | 11325 Copies/mL | 18 | Cpara | 399 CFU/mL |
| 4 | Cpara | 61013 CFU/mL | 11 | Cpara | 153300 CFU/mL | 18 | Cpara | 399 CFU/mL |
| 5 | Ljens | 1015 CFU/mL | 12 | Ljens | 2550 CFU/mL | 19 | Cdub | 52 CFU/mL |
| 5 | Cdub | 7964 CFU/mL | 12 | Cdub | 20010 CFU/mL | 19 | Cdub | 52 CFU/mL |
| 6 | Lcrisp | 109 CFU/mL | 13 | Lcrisp | 275 CFU/mL | 20 | Ctrop | 16 CFU/mL |
| 6 | Ctrop | 623 CFU/mL | 13 | Ctrop | 1565 CFU/mL | 20 | Ctrop | 16 CFU/mL |
| 7 | Ato | 253 CFU/mL | 14 | Ato | 635 CFU/mL | |||
| 7 | TV | 44 Cells/mL | 14 | TV | 110 Cells/mL |
Table 9: Analytical Sensitivity Confirmation Panel Members
| Table 10: Analytical Sensitivity Confirmation in Vaginal Swab for BD CORT™ System for the |
|---|
| Vaginosis Targets |
| Target | Target
Level | System | N | Proportion
Positivity | Mean Ct.Score | Difference in
Mean Ct.Score
[COR - MAX] and
90% CI | Equivalence
Interval | Equivalence
Established |
|-----------------------------------|----------------------|--------|----|--------------------------|---------------|-------------------------------------------------------------|-------------------------|----------------------------|
| Atopobium
vaginae | Low
Positive | COR | 48 | 100% | 26.23 | 0.21 | (-1.56, 1.56) | Yes |
| | Low
Positive | MAX | 48 | 100% | 26.02 | (0.11, 0.31) | | |
| Atopobium
vaginae | Moderate
Positive | COR | 48 | 100% | 25.02 | 0.12 | (-1.49, 1.49) | Yes |
| | Moderate
Positive | MAX | 48 | 100% | 24.90 | (-0.02, 0.26) | | |
| BVAB-2* | Low
Positive | COR | 48 | 100% | 29.79 | 0.19 | (-1.78, 1.78) | Yes |
| | Low
Positive | MAX | 48 | 100% | 29.60 | (0.06, 0.33) | | |
| BVAB-2* | Moderate
Positive | COR | 48 | 100% | 28.52 | 0.21 | (-1.70, 1.70) | Yes |
| | Moderate
Positive | MAX | 48 | 100% | 28.31 | (0.10, 0.32) | | |
| Megasphaera* | Low
Positive | COR | 48 | 98% | 30.35 | 0.34 | (-1.80, 1.80) | Yes |
| | Low
Positive | MAX | 48 | 100% | 30.01 | (0.15, 0.52) | | |
| Megasphaera* | Moderate
Positive | COR | 48 | 100% | 29.18 | 0.27 | (-1.73, 1.73) | Yes |
| | Moderate
Positive | MAX | 48 | 100% | 28.91 | (0.13, 0.41) | | |
| Gardnerella
vaginallis | Low
Positive | COR | 48 | 100% | 28.69 | 0.23 | (-1.71, 1.71) | Yes |
| | Low
Positive | MAX | 48 | 98% | 28.45 | (0.12, 0.34) | | |
| | Moderate | COR | 48 | 100% | 27.47 | 0.20 | | |
15
| Target | Target
Level | System | N | Proportion
Positivity | Mean Ct.Score | Difference in
Mean Ct.Score
[COR - MAX] and
90% CI | Equivalence
Interval | Equivalence
Established |
|----------------------------|----------------------|--------|----|--------------------------|---------------|-------------------------------------------------------------|-------------------------|----------------------------|
| | Positive | MAX | 48 | 100% | 27.27 | (0.10, 0.30) | | |
| Lactobacillus
jensenii | Low
Positive | COR | 48 | 100% | 24.65 | 0.50 | | Yes |
| | | MAX | 48 | 100% | 24.15 | (0.39, 0.61) | (-1.45, 1.45) | |
| | Moderate
Positive | COR | 48 | 100% | 23.41 | 0.48 | | Yes |
| | | MAX | 48 | 100% | 22.93 | (0.39, 0.57) | (-1.38, 1.38) | |
| | Low
Positive | COR | 48 | 100% | 26.52 | 0.40 | | |
| Lactobacillus
crispatus | Positive | MAX | 48 | 100% | 26.12 | (0.24, 0.56) | (-1.57, 1.57) | Yes |
| | Moderate
Positive | COR | 48 | 100% | 25.18 | 0.27 | | Yes |
| | Positive | MAX | 48 | 100% | 24.91 | (0.15, 0.39) | (-1.49, 1.49) | |
*BVAB and Megasheara on non-cultivatable organisms. Plasmids were used for the LoD confirmation study.
Table 11: Analytical Sensitivity Confirmation in Vaginal Swab for BD COR™ System for the Vaginitis Targets
| Target | Target Level | System | N | Proportion
Positivity
(95% CI for
High
Negatives) | Mean
SDPA | Difference in
Mean SDPA
[COR - MAX]
with 90% CI | Equivalence
Interval | Equivalence
Established |
|-----------------------|-------------------|--------|----|---------------------------------------------------------------|--------------|----------------------------------------------------------|-------------------------|----------------------------|
| Trichomonas vaginalis | Low Positive | COR | 48 | 100% | 32.31 | 0.17 | (-1.93, 1.93) | Yes |
| | Low Positive | MAX | 48 | 100% | 32.14 | (0.06, 0.28) | | |
| Trichomonas vaginalis | Moderate Positive | COR | 48 | 100% | 31.34 | -0.10 | (-1.89, 1.89) | Yes |
| | Moderate Positive | MAX | 48 | 100% | 31.44 | (-0.21, 0.01) | | |
| Candida albicans | *High Negative | COR | 48 | 90%
(78%, 95%) | 34.33 | | | |
| | *High Negative | MAX | 48 | 90%
(78%, 95%) | 34.30 | | | |
| Candida albicans | Low Positive | COR | 48 | 100% | 27.75 | 0.15 | (-1.66, 1.66) | Yes |
| | Low Positive | MAX | 48 | 100% | 27.61 | (0.00, 0.29) | | |
| Candida albicans | Moderate Positive | COR | 48 | 100% | 26.89 | 0.07 | (-1.61, 1.61) | Yes |
| | Moderate Positive | MAX | 48 | 100% | 26.82 | (-0.12, 0.26) | | |
| Candida parapsilosis | *High Negative | COR | 48 | 71%
(57%, 82%) | 35.39 | | | |
| | *High Negative | MAX | 48 | 67%
(53%, 78%) | 35.17 | | | |
| Candida parapsilosis | Low Positive | COR | 48 | 100% | 29.39 | 0.43 | (-1.74, 1.74) | Yes |
| | Low Positive | MAX | 48 | 100% | 28.96 | (0.21, 0.65) | | |
| Candida parapsilosis | Moderate Positive | COR | 48 | 100% | 28.15 | 0.31 | (-1.67, 1.67) | Yes |
| | Moderate Positive | MAX | 48 | 100% | 27.85 | (0.08, 0.53) | | |
| Candida tropicalis | *High Negative | COR | 48 | 85%
(73%, 93%) | 34.69 | | | |
| | *High Negative | MAX | 48 | 85%
(73%, 93%) | 34.45 | | | |
| Candida tropicalis | Low Positive | COR | 48 | 100% | 30.83 | 0.28 | (-1.83, 1.83) | Yes |
| | Low Positive | MAX | 48 | 100% | 30.55 | (0.12, 0.44) | | |
| Candida tropicalis | Moderate Positive | COR | 48 | 100% | 29.92 | 0.22 | (-1.78, 1.78) | |
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| Target | Target Level | System | N | Proportion
Positivity
(95% CI for
High
Negatives) | Mean
SDPA | Difference in
Mean SDPA
[COR - MAX]
with 90% CI | Equivalence
Interval | Equivalence
Established |
|----------------------|-------------------|--------|----|---------------------------------------------------------------|--------------|----------------------------------------------------------|-------------------------|----------------------------|
| Candida dubliniensis | | MAX | 48 | 100% | 29.70 | (0.06, 0.37) | | |
| | *High Negative | COR | 48 | 58%
(44%, 71%) | 34.20 | | | |
| | *High Negative | MAX | 48 | 65%
(50%, 77%) | 34.54 | | | |
| Candida dubliniensis | Low Positive | COR | 48 | 100% | 28.92 | 0.39 | (-1.71, 1.71) | Yes |
| | Low Positive | MAX | 48 | 100% | 28.53 | (0.19, 0.59) | | |
| | Moderate Positive | COR | 48 | 100% | 27.66 | 0.22 | (-1.65, 1.65) | Yes |
| | Moderate Positive | MAX | 48 | 100% | 27.43 | (0.02, 0.43) | | |
| Candida glabrata | *High Negative | COR | 48 | 73%
(59%, 83%) | 36.04 | | | |
| | *High Negative | MAX | 48 | 69%
(55%, 80%) | 37.83 | | | |
| | Low Positive | COR | 48 | 100% | 29.64 | 0.05 | | Yes |
| | Low Positive | MAX | 48 | 100% | 29.59 | (-0.12, 0.22) | (-1.78, 1.78) | |
| | Moderate Positive | COR | 48 | 100% | 28.59 | 0.26 | | Yes |
| | Moderate Positive | MAX | 48 | 100% | 28.33 | (0.12, 0.40) | (-1.70, 1.70) | |
| Candida krusei | *High Negative | COR | 48 | 44%
(31%, 58%) | 36.48 | | | |
| | *High Negative | MAX | 48 | 54%
(40%, 67%) | 36.55 | | | |
| | Low Positive | COR | 48 | 100% | 29.35 | 0.32 | | Yes |
| | Low Positive | MAX | 48 | 100% | 29.04 | (0.14, 0.50) | (-1.74, 1.74) | |
| | Moderate Positive | COR | 48 | 100% | 28.17 | 0.28 | (-1.67, 1.67) | |
| | Moderate Positive | MAX | 48 | 100% | 27.89 | (0.16, 0.40) | | Yes |
*TOST analysis was not performed on High Negative Candida spp. (CS) panel members based on the proportion positivity being less than 95% at C5, a predicate requirement. Overlapping 95% confidence intervals between the both the BD MAX and COR platforms indicates equivalency at the High Negative level.
Cross-Contamination for BD CORTM System
A study was conducted to investigate cross-contamination while processing samples with high bacterial loads of BD Vaginal Panel targets. A panel made of alternating high positive and negative members was used at a prevalence of 50% high positive samples to simulate the most sensitive case for cross-contamination. In the high positive panel member, vaginosis markers were represented by a combination of L. jensenii (5.57E+07 CFU/mL), G. vaginalis (4.29E+07 CFU/mL), A. vaginae (1.65E+08 CFU/mL), and BVAB-2 (1.00E+09 copies/mL) while vaginitis targets were represented by T. vaginalis (8.0E+03 cells/mL). The negative member did not contain any target analytes. Of the 543 negative samples tested, 1 false positive result was observed, demonstrating a contamination rate of 0.18% (95% CI: 0.03- 1.04%), which met the predefined study acceptance criteria. Clinical Agreement Study between BD MAX™ and BD COR™ Systems
The performance of the BD Vaginal Panel on the BD COR™ System 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 the reference in the clinical agreement study.
Clinical vaginal specimens obtained from both internal collections were used for this comparison study. Clinical panels were created by pooling the previously collected clinical specimens and, where necessary, spiking in a high positive clinical specimen or pooling positive specimens at specific Secondary Derivative Peak Abscissa (SDPAs) to reach the necessary analyte
17
level(s) for Cgroup and TV. In addition, contrived samples were created by spiking organisms into simulated matrix. For C. glabrata and C. krusei, contrived samples were created by spiking organisms into negative vaginal matrix or in simulated vaginal matrix because of their very low prevalence. For BV, contrived panel members with different BV marker combinations were prepared using simulated vaginal matrix. These samples are denoted as BV Contrived. Additionally, the Cgroup, TV, and negative vaginitis panel members in natural vaginal matrix were analyzed for BV targets. These samples are denoted as BV Natural.
The clinical agreement study included 700 panel members. The panel members were prepared so the majority of positive specimens for each analyte were at the low positive and moderate positive level. Three aliquots were prepared for each panel member. Each aliquot was tested on the BD COR™ System and BD MAX ™ System with the order of system testing randomized. Testing occurred at two external sites and one internal site.
To demonstrate that the performance of the BD Vaginal Panel on the BD CORTM System is equivalent to the performance on BD MAX™, both positive/negative percent agreement analysis and Deming regression analysis of the Ct.Score or SDPA values were performed. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) between the BD MAX™ and the BD COR™ Systems were calculated separately for each target, the PPA and NPA were calculated for each of the three sites where BD COR™ testing occurred, against composite comparator results where the positive or negative status of a panel member is defined by >2 out of 3 evaluable results obtained on the BD MAX™. PPA and NPA estimates were also averaged across the three BD COR™ testing sites. The PPA and NPA results as well as the corresponding 95% confidence interval at each BD COR™ testing site and the average across all three BD COR™ testing sites are summarized in Tables 14-19 for each target. The denominator for PPA and NPA calculations includes panel members with equivocal comparator results from BD MAX™, as indicated at the bottom of the tables. Equivocal BD MAX™ comparator result is defined as one positive, one negative, and one non-evaluable result from the BD MAXTM.
The systematic differences in numeric value between Ct.Score or SDPA results from BD COR™ and BD MAX™ were evaluated by the Weighted Deming regression analysis based on the average Ct.Score or SDPA of BD COR™ results and the average Ct.Score or SDPA of BD MAX™ results of a given panel member across all corresponding testing sites. The results from the Deming regression analysis are provided in Figure 1 - Figure 4-4 for C. albicans, C. glabrata, C. krusei, and TV. Due to the aggregate BV result reporting, the Deming results are not provided for the Vaginosis targets (Atopobium vaginae, Gardnerella vaginalis, Lactobacillus spp., BVAB-2 and Megasphera-1). The point estimate of intercept and slope as well as the corresponding 95% Confidence Interval of each Deming regression line are provided in Table 20. Additionally, the Weighted Deming regression bias estimate along with 95% confidence interval at different analyte levels are presented in Table 21.
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| Table 12: Percent Agreement of BD COR™ versus BD MAX™ Result by Test Site for BV | ||
|---|---|---|
| Contrived Specimens |
| Targeted Organism: BV Contrived | BD MAX™ Result | ||
|---|---|---|---|
| BD COR™ Test Site | BD COR™ Result | Positive | Negative |
| 1 | Positive | 72 | 0 |
| Negative | 0 | 100 | |
| Total | 72 | 100 | |
| PPA: 100% (72/72); 95% CI: (94.9, 100) | |||
| NPA: 100% (100/100); 95% CI: (96.3, 100) | |||
| OPA: 100% (172/172); 95% CI: (97.8, 100) | |||
| Number of non-evaluable samples: 0 | |||
| 2 | Positive | 71 | 0 |
| Negative | 1 | 100 | |
| Total | 72 | 100 | |
| PPA: 98.6% (71/72); 95% CI: (92.5, 99.8) | |||
| NPA: 100% (100/100); 95% CI: (96.3, 100) | |||
| OPA: 99.4% (171/172); 95% CI: (96.8, 99.9) | |||
| Number of non-evaluable samples: 0 | |||
| 3 | Positive | 72 | 0 |
| Negative | 0 | 100 | |
| Total | 72 | 100 | |
| PPA: 100% (72/72); 95% CI: (94.9, 100) | |||
| NPA: 100% (100/100); 95% CI: (96.3 100) | |||
| OPA: 100% (172/172); 95% CI: (97.8, 100) | |||
| Number of non-evaluable samples: 0 | |||
| Overall: | |||
| Average PPA: 99.5%; Bootstrap 95% CI: (98.4, 100) | |||
| Average NPA: 100%; Bootstrap 95% CI: N/A | |||
| Average OPA: 99.8%; Bootstrap 95% CI: (99.3, 100) | |||
| Average number of BD MAX™ equivocal results: 0 | |||
| Note 1: Confidence intervals for point estimates at each site are calculated by a score method. | |||
| Note 2: Confidence intervals for point estimates averaged over 3 sites are calculated by a bootstrap method. |
19
Table 13: Percent Agreement of BD COR™ versus BD MAX™ Result by Test Site for BV Natural Specimens
| Targeted Organism: BV Natural | BD MAX™ Result | ||
|---|---|---|---|
| BD COR™ Test Site | BD COR™ Result | Positive | Negative |
| 1 | Positive | 226 | 6 |
| Negative | 6 | 114 | |
| Total | 232 | 120 | |
| PPA: 97.4% (226/232); 95% CI: (94.5, 98.8) | |||
| NPA: 95.0% (114/120); 95% CI: (89.5, 97.7) | |||
| OPA: 96.6% (340/352); 95% CI: (94.1, 98.0) | |||
| Number of non-evaluable samples: 2 | |||
| 2 | Positive | 228 | 4 |
| Negative | 5 | 116 | |
| Total | 233 | 120 | |
| PPA: 97.9% (228/233); 95% CI: (95.1, 99.1) | |||
| NPA: 96.7% (116/120); 95% CI: (91.7, 98.7) | |||
| OPA: 97.5% (344/353); 95% CI: (95.2, 98.7) | |||
| Number of non-evaluable samples: 1 | |||
| 3 | Positive | 228 | 5 |
| Negative | 4 | 113 | |
| Total | 232 | 118 | |
| PPA: 98.3% (228/232); 95% CI: (95.7, 99.3) | |||
| NPA: 95.8% (113/118); 95% CI: (90.5, 98.2) | |||
| OPA: 97.4% (341/350); 95% CI: (95.2, 98.6) | |||
| Number of non-evaluable samples: 4 | |||
| Overall: | |||
| Average PPA: 97.8%; Bootstrap 95% CI: (96.3, 99.1) | |||
| Average NPA: 95.8%; Bootstrap 95% CI: (93.1, 98.2) | |||
| Average OPA: 97.2%; Bootstrap 95% CI: (95.8, 98.4) | |||
| Average number of BD MAX™ equivocal results: 0 | |||
| Note 1: Confidence intervals for point estimates at each site are calculated by a score method. | |||
| Note 2: Confidence intervals for point estimates averaged over 3 sites are calculated by a bootstrap |
| method.
20
| Targeted Organism: C. glabrata | BD MAXTM Result | ||
|---|---|---|---|
| BD CORTM Test Site | BD CORTM Result | Positive | Negative |
| 1 | Positive | 58 | 0 |
| Negative | 0 | 125 | |
| Total | 58 | 125 | |
| PPA: 100% (58/58); 95% CI: (93.8, 100) | |||
| NPA: 100% (125/125); 95% CI: (97.0, 100) | |||
| OPA: 100% (183/183); 95% CI: (97.9, 100) | |||
| Number of non-evaluable samples: 1 | |||
| 2 | Positive | 57 | 0 |
| Negative | 0 | 125 | |
| Total | 57 | 125 | |
| PPA: 100% (57/57); 95% CI: (93.7, 100) | |||
| NPA: 100% (125/125); 95% CI: (97.0, 100) | |||
| OPA: 100% (182/182); 95% CI: (97.9, 100) | |||
| Number of non-evaluable samples: 2 | |||
| 3 | Positive | 57 | 0 |
| Negative | 0 | 122 | |
| Total | 57 | 122 | |
| PPA: 100% (57/57); 95% CI: (93.7, 100) | |||
| NPA: 100% (122/122); 95% CI: (96.9, 100) | |||
| OPA: 100% (179/179); 95% CI: (97.9, 100) | |||
| Number of non-evaluable samples: 5 | |||
| Overall: | |||
| Average PPA: 100%; Bootstrap 95% CI: N/A | |||
| Average NPA: 100%; Bootstrap 95% CI: N/A | |||
| Average OPA: 100%; Bootstrap 95% CI: N/A | |||
| Average number of BD MAXTM equivocal results: 0 | |||
| Note 1: Confidence intervals for point estimates at each site are calculated by a score method. | |||
| Note 2: Confidence intervals for point estimates averaged over 3 sites are calculated by a bootstrap method |
Table 14: Percent Agreement of BD COR™ versus BD MAX™ Result by Test Site for C. glabrata
21
| Targeted Organism: C. krusei | BD MAX™ Result | ||
|---|---|---|---|
| BD CORT™ Test Site | BD CORT™ Result | Positive | Negative |
| 1 | Positive | 50 | 0 |
| Negative | 0 | 125 | |
| Total | 50 | 125 | |
| PPA: 100% (50/50); 95% CI: (92.9, 100) | |||
| NPA: 100% (125/125); 95% CI: (97.0, 100) | |||
| OPA: 100% (175/175); 95% CI: (97.9, 100) | |||
| Number of non-evaluable samples: 2 | |||
| 2 | Positive | 49 | 0 |
| Negative | 0 | 125 | |
| Total | 49 | 125 | |
| PPA: 100% (49/49); 95% CI: (92.7, 100) | |||
| NPA: 100% (125/125); 95% CI: (97.0, 100) | |||
| OPA: 100% (174/174); 95% CI: (97.8, 100) | |||
| Number of non-evaluable samples: 3 | |||
| 3 | Positive | 51 | 0 |
| Negative | 0 | 122 | |
| Total | 51 | 122 | |
| PPA: 100% (51/51); 95% CI: (93.0, 100) | |||
| NPA: 100% (122/122); 95% CI: (96.9, 100) | |||
| OPA: 100% (173/173); 95% CI: (97.8, 100) | |||
| Number of non-evaluable samples: 4 | |||
| Overall: | |||
| Average PPA: 100%; Bootstrap 95% CI: N/A | |||
| Average NPA: 100%; Bootstrap 95% CI: N/A | |||
| Average OPA: 100%; Bootstrap 95% CI: N/A | |||
| Average number of BD MAX™ equivocal results: 0 | |||
| Note 1: Confidence intervals for point estimates at each site are calculated by a score method. | |||
| Note 2: Confidence intervals for point estimates averaged over 3 sites are calculated by a bootstrap method. |
Table 15: Percent Agreement of BD COR™ versus BD MAX™ Result by Test Site for C. krusei
22
| Targeted Organism: Candida Group | BD MAX™ Result | ||
|---|---|---|---|
| BD CORT™ Test Site | BD COR™ Result | Positive | Negative |
| 1 | Positive | 115 | 1 |
| Negative | 2 | 124 | |
| Total | 117 | 125 | |
| PPA: 98.3% (115/117); 95% CI: (94.0, 99.5) | |||
| NPA: 99.2% (124/125); 95% CI: (95.6, 99.9) | |||
| OPA: 98.8% (239/242); 95% CI: (96.4, 99.6) | |||
| Number of non-evaluable samples: 2 | |||
| 2 | Positive | 117 | 2 |
| Negative | 0 | 123 | |
| Total | 117 | 125 | |
| PPA: 100% (117/117); 95% CI: (96.8, 100) | |||
| NPA: 98.4% (123/125); 95% CI: (94.4, 99.6) | |||
| OPA: 99.2% (240/242); 95% CI: (97.0, 99.8) | |||
| Number of non-evaluable samples: 2 | |||
| 3 | Positive | 118 | 1 |
| Negative | 0 | 121 | |
| Total | 118 | 122 | |
| PPA: 100% (118/118); 95% CI: (96.8, 100) | |||
| NPA: 99.2% (121/122); 95% CI: (95.5, 99.9) | |||
| OPA: 99.6% (239/240); 95% CI: (97.7, 99.9) | |||
| Number of non-evaluable samples: 4 | |||
| Overall: | |||
| Average PPA: 99.4%; Bootstrap 95% CI: (98.5, 100) | |||
| Average NPA: 98.9%; Bootstrap 95% CI: (97.4, 100) | |||
| Average OPA: 99.2%; Bootstrap 95% CI: (98.3, 99.9) | |||
| Average number of BD MAX™ equivocal results: 0 | |||
| Note 1: Confidence intervals for point estimates at each site are calculated by a score method. | |||
| Note 2: Confidence intervals for point estimates averaged over 3 sites are calculated by a bootstrap method |
Table 16: Percent Agreement of BD COR™ versus BD MAX™ Result by Test Site for Cgroup
23
| Targeted Organism: TV | BD MAX Result | ||
|---|---|---|---|
| BD COR Test Site | BD COR Result | Positive | Negative |
| 1 | Positive | 110 | 0 |
| Negative | 0 | 125 | |
| Total | 110 | 125 | |
| PPA: 100% (110/110); 95% CI: (96.6, 100) | |||
| NPA: 100% (125/125); 95% CI: (97.0, 100) | |||
| OPA: 100% (235/235); 95% CI: (98.4, 100) | |||
| Number of non-evaluable samples: 1 | |||
| 2 | Positive | 109 | 0 |
| Negative | 1 | 125 | |
| Total | 110 | 125 | |
| PPA: 99.1% (109/110); 95% CI: (95.0, 99.8) | |||
| NPA: 100% (125/125); 95% CI: (97.0, 100) | |||
| OPA: 99.6% (234/235); 95% CI: (97.6, 99.9) | |||
| Number of non-evaluable samples: 1 | |||
| 3 | Positive | 110 | 0 |
| Negative | 0 | 122 | |
| Total | 110 | 122 | |
| PPA: 100% (110/110); 95% CI: (96.6, 100) | |||
| NPA: 100% (122/122); 95% CI: (96.9, 100) | |||
| OPA: 100% (232/232); 95% CI: (98.4, 100) | |||
| Number of non-evaluable samples: 4 | |||
| Overall: | |||
| Average PPA: 99.7%; Bootstrap 95% CI: (99.0, 100) | |||
| Average NPA: 100%; Bootstrap 95% CI: N/A | |||
| Average OPA: 99.9%; Bootstrap 95% CI: (99.5, 100) | |||
| Average number of BD MAX™ equivocal results: 0 | |||
| Note 1: Confidence intervals for point estimates at each site are calculated by a score method. | |||
| Note 2: Confidence intervals for point estimates averaged over 3 sites are calculated by a bootstrap method. |
Table 17: Percent Agreement of BD COR™ versus BD MAX™ Result by Test Site for TV
Table 18: Weighted Deming Regression Coefficients for Ct.Score for BD COR™ vs. BD MAX™
| Master Mix | Target | Site | Intercept (95%CI) | Slope (95%CI) |
|---|---|---|---|---|
| MM2 | ||||
| (SDPA) | C. glabrata | 1.00 (-4.13, 6.12) | 0.98 (0.80, 1.16) | |
| Cgroup | Overall | -5.44 (-8.29, -2.59) | 1.19 (1.09, 1.30) | |
| C. krusei | 3.08 (-1.53, 7.68) | 0.90 (0.73, 1.06) | ||
| TV | -2.77 (-4.63, -0.91) | 1.09 (1.02, 1.15) |
24
| Master
Mix | Target | Actual Level | Ct.score/SDPA
of BD MAXTM | Bias
Estimate | 95% CI |
|---------------|--------------------|---------------|------------------------------|------------------|----------------|
| MM2
(SDPA) | C. glabrata | High Positive | 27.68 | 0.38 | (0.15, 0.62) |
| | | Moderate | 28.96 | 0.36 | (0.19, 0.53) |
| | | Positive | 29.87 | 0.34 | (0.06, 0.61) |
| | | Low Positive | 40.00 | 0.11 | (-1.92, 2.15) |
| | | Negative | 24.05 | -0.83 | (-1.21, -0.45) |
| | Cgroup | High Positive | 27.16 | -0.23 | (-0.42, -0.04) |
| | | Moderate | 30.12 | 0.34 | (-0.03, 0.70) |
| | | Positive | 40.00 | 2.23 | (0.87, 3.59) |
| | | Low Positive | 27.00 | 0.32 | (0.09, 0.55) |
| | C. krusei | Negative | 28.33 | 0.19 | (0.06, 0.31) |
| | | High Positive | 29.59 | 0.06 | (-0.20, 0.32) |
| | | Moderate | 40.00 | -1.00 | (-2.93, 0.93) |
| | | Positive | 26.36 | -0.48 | (-0.76, -0.21) |
| | TV | Low Positive | 30.24 | -0.14 | (-0.31, 0.03) |
| | | Negative | 32.83 | 0.08 | (-0.17, 0.33) |
| | | High Positive | 40.00 | 0.70 | (0.05, 1.35) |
| | | Moderate | | | |
Table 19: Weighted Deming Regression Bias Estimate for BD COR™ vs. BD MAX™
25
Image /page/25/Figure/1 description: This image is a figure titled "Figure 1: Deming Regression for the BD Vaginal Panel on the BD CORT™ System versus the BD MAX™ System – C. glabrata". The figure is comparing the BD CORT system to the BD MAX system. The figure is for C. glabrata.
Image /page/25/Figure/2 description: The image is a scatter plot that compares COR SDPA Score and MAX SDPA Score. The plot includes a Deming Regression Fit line with the equation 1 + 0.98 * MAX SDPA Score, and an identity line. The Pearson's r correlation coefficient is 0.708, indicating a strong positive correlation between the two variables. The Deming Regression Fit is based on a sample size of n=58.
The 0.95-confidence bounds are calculated with the jackknife method.
26
Image /page/26/Figure/1 description: This image is titled "Figure 2: Deming Regression for the BD Vaginal Panel on the BD CORT™ System versus the BD MAXT™ System - Cgroup". The image is a title for a figure. The title describes a Deming Regression analysis performed on the BD Vaginal Panel. The analysis compares the BD CORT™ System with the BD MAXT™ System within the Cgroup.
Image /page/26/Figure/2 description: The image is a scatter plot that compares COR SDPA Score and MAX SDPA Score. The plot includes a Deming Regression Fit line, represented by the equation -5.44 + 1.19 * MAX SDPA Score, along with an identity line. The Pearson's r correlation coefficient is 0.938, indicating a strong positive correlation between the two scores. The Deming Regression Fit is based on a sample size of 114.
The 0.95-confidence bounds are calculated with the jackknife method.
27
Image /page/27/Figure/1 description: The image is a title for a figure. The title states, "Figure 3: Deming Regression for the BD Vaginal Panel on the BD CORT™ System versus the BD MAX™ System – C. krusei".
Image /page/27/Figure/2 description: The image is a scatter plot that shows the relationship between COR SDPA Score and MAX SDPA Score. The plot includes a Deming Regression Fit line, represented by the equation 3.08 + 0.9 * MAX SDPA Score, along with a shaded confidence interval. There is also a dashed line representing the identity line. The Pearson's r correlation coefficient is 0.881, indicating a strong positive correlation between the two variables.
MAX SDPA Score The 0.95-confidence bounds are calculated with the jackknife method.
28
Figure 4: Deming Regression for the BD Vaginal Panel on the BD COR™ System versus the BD MAXTM System - TV
Image /page/28/Figure/2 description: The image is a scatter plot that compares COR SDPA Score and MAX SDPA Score. The x-axis represents MAX SDPA Score, ranging from 15 to 40, while the y-axis represents COR SDPA Score, also ranging from 15 to 40. A Deming Regression Fit line is plotted with the equation -2.77 + 1.09 * MAX SDPA Score, along with an identity line, and the Pearson's r correlation coefficient is 0.962.
The 0.95-confidence bounds are calculated with the jackknife method.
BD Vaginal Panel Non-Reportable Results for BD COR™ System
As with BD MAX™, BD COR™ System results that were due to an internal control failure, extraction transfer failure, or liquid level failure are considered non-reportable. Additionally, on BD COR™ System, incomplete (INC) results may occur on the MX instrument after the specimen has been aspirated for extraction (i.e., aborted runs due to Inventory Robot (IR) error). INC results that occur on MX were also included in the BD COR™ System non-reportable rate calculation. Error results on BD COR™ System were marked noncompliant if they were due to an operator error and were not included in the Non-reportable rate calculation. Non-reportable rates on BD COR™ System are shown in Table 22.
29
Table 20: Summary of BD COR™ Total Non-Reportable Rate for Combined Target by BD COR™ Test Site
| Combined
Target
BD CORTM
Test Site | Unresolvedb Rate | | Indeterminatec Rate | | Incompleted Rate | | Total UNR+IND+INC
Rate | |
|---------------------------------------------|---------------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------|--------------------------------|---------------------------------|--------------------------------|
| | Initial
(95% CI) | Finala
(95% CI) | Initial
(95% CI) | Finala
(95% CI) | Initial
(95% CI) | Finala
(95% CI) | Initial
(95% CI) | Finala
(95% CI) |
| 1 | 0.6%
(4/681)
(0.2, 1.5) | 0.0%
(0/681)
(0.0, 0.6) | 0.0%
(0/681)
(0.0, 0.6) | 0.0%
(0/681)
(0.0, 0.6) | 0.0%
(0/681)
(0.0, 0.6) | 0.0%
(0/681)
(0.0, 0.6) | 0.6%
(4/681)
(0.2, 1.5) | 0.0%
(0/681)
(0.0, 0.6) |
| 2 | 0.6%
(4/685)
(0.2, 1.5) | 0.0%
(0/683)
(0.0, 0.6) | 0.4%
(3/685)
(0.1, 1.3) | 0.0%
(0/683)
(0.0, 0.6) | 0.0%
(0/685)
(0.0, 0.6) | 0.0%
(0/683)
(0.0, 0.6) | 1.0%
(7/685)
(0.5, 2.1) | 0.0%
(0/683)
(0.0, 0.6) |
| 3 | 0.3%
(2/681)
(0.1, 1.1) | 0.0%
(0/680)
(0.0, 0.6) | 0.0%
(0/681)
(0.0, 0.6) | 0.0%
(0/680)
(0.0, 0.6) | 0.0%
(0/681)
(0.0, 0.6) | 0.0%
(0/680)
(0.0, 0.6) | 0.3%
(2/681)
(0.1, 1.1) | 0.0%
(0/680)
(0.0, 0.6) |
| Overall | 0.5%
(10/2047)
(0.3, 0.9) | 0.0%
(0/2044)
(0.0, 0.2) | 0.1%
(3/2047)
(0.0, 0.4) | 0.0%
(0/2044)
(0.0, 0.2) | 0.0%
(0/2047)
(0.0, 0.2) | 0.0%
(0/2044)
(0.0, 0.2) | 0.6%
(13/2047)
(0.4, 1.1) | 0.0%
(0/2044)
(0.0, 0.2) |
a The final rate is calculated with the number of remaining non-reportable events after repeat testing.
b Unresolved, invalid SPC due to presence of inhibitory substances or reagent failure.
c Indeterminate, BD COR™ System failure (with Warning or Error Codes).
d Incomplete Run, aborted run or BD COR™ System failure that halts robot operations (with Warning or Error Codes).