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/or Trichomonas vaginalis. 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 (BV) markers (Individual markers are not reported)
- o Lactobacillus spp. (L. crispatus and L. jensenii)
- o Gardnerella vaginalis
- o Atopobium vaginae
- o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
- o Megasphaera-1
· Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups)

o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)

o Candida glabrata
o Candida krusei
· Trichomonas vaginalis (TV)

The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. 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.

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 bacterial vaginosis (qualitative results reported based on detection and of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. 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)
- o Lactobacillus spp. (L. crispatus and L. jensenii)
- o Gardnerella vaginalis
- o Atopobium vaginae
- o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
- o Megasphaera-1
· Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups)
- o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis)
- o Candida glabrata
- o Candida krusei
• Trichomonas vaginalis (TV)

The assay may be used to detect BV, VVC, and/or TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD MAX™ Vaginal is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

Device Description

The BD Vaginal Panel is an automated, qualitative in vitro diagnostic test for bacterial vaginosis markers. Candida species associated with vulyovaginal candidiasis, and Trichomonas vaginalis. From a single specimen, a vaginal swab collected from a patient who is symptomatic for vaginitis or vaginosis, the test provides qualitative (positive) results for the presence of the following conditions and/or organisms:

Bacterial vaginosis (based on detection of Lactobacillus spp. (L. crispatus and L. . jensenii), Gardnerella vaginalis, Atopobium vaginae, Bacterial Vaginosis Associated Bacteria-2, and Megasphaera-1)
Candida spp. (C. albicans, c. tropicalis, C. parapsilosis, and C. dubliniensis) .
Candida glabrata ●
Candida krusei ●
Trichomonas vaginalis ●

The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System under the trade names BD MAX™ Vaginal Panel and BD Vaginal Panel, respectively. The assay previously provided results for all five targets for every specimen run, regardless of whether the ordering clinician desires evaluation of all reported conditions. After clearance of this 510(k) submission, BD will release updates to the BD MAX™ and BD COR ™ software to allow users the versatility to mask results, per specimen, based on the order received from the clinician. This change allows a laboratory to use the BD Vaginal Panel to test a specimen for an individual target group (BV, VVC, or TV) or any two of the three targeted conditions, in addition to the current configuration that reports all three conditions simultaneously.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BD Vaginal Panel, an in vitro diagnostic test. While the document details the device's intended use, technological principles, and comparison to a predicate device, it does not contain specific acceptance criteria and detailed study results in the format usually provided for device performance evaluation against such criteria. Instead, it states that "The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001" and that enabling a subset of results to be masked "has no clinical impact," implying that performance data was previously established and still applies.

Therefore, I cannot extract a table of acceptance criteria and reported device performance from the provided text, nor can I provide specific details on sample sizes, ground truth establishment, or expert involvement for the test set.

However, I can describe the basis for the claim of continued performance and what typically would be found in a complete submission to address these points.

Based on the provided text, here's what can be inferred and what information is missing:

Inferred Information Regarding Acceptance Criteria and Study to Prove Device Meets Them:

The core of the argument for "acceptance" in this submission (K243725) is that the changes to the BD Vaginal Panel (specifically, the ability to mask results for certain conditions based on clinician order) do not impact the analytical or clinical performance that was already established for the predicate device (BD Vaginal Panel, referenced by DEN160001, K191957, K201017, K223653).

The text states:

"The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001."
"BD has determined that introducing the capability to order a subset of the conditions evaluated by the Vaginal Panel while masking the results for those conditions that are not ordered has no clinical impact."
"Enabling the assay to report results for only a subset of the conditions does not change the specimen type, the test conditions, or the logic that is used to determine whether a specimen is positive or negative for the associated condition: conditions that are not ordered are simply not reported to the user."
"Therefore, analytical and clinical performance of the assays is not impacted."

This implies that the previous submissions (DEN160001, K191957, K201017, K223653) would contain the detailed study data that established the acceptance criteria and demonstrated the device's performance against them. The current submission is a modification where the manufacturer asserts that the modification does not alter the already proven performance.

Unavailable Information from the Provided Text:

Since this submission argues "no impact" on performance rather than providing new performance data, the following specific details are not present in the provided document:

A table of acceptance criteria and the reported device performance: This information would be in the predicate device's summary (e.g., DEN160001). The current submission leverages the established performance.
Sample sizes used for the test set and the data provenance: Not provided for this submission's changes, as it relies on previous data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided for this submission's changes.
Adjudication method for the test set: Not provided for this submission's changes.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a molecular diagnostic test, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as an "automated qualitative in vitro diagnostic test," meaning its performance is its standalone performance without continuous human interpretation of raw data. The "human-in-the-loop" aspect here is the clinician receiving the final positive/negative result. The change highlighted in this 510(k) is masking results, not altering the fundamental detection algorithm.
The type of ground truth used: Not explicitly stated for this submission's changes, but for molecular diagnostics, ground truth typically involves a combination of clinical diagnosis, other laboratory methods (e.g., microscopy, culture, or other validated molecular assays), and sometimes expert clinical assessment.
The sample size for the training set: Not applicable as this is not an AI/ML device that requires a separate "training set" in that context. The "training" in molecular diagnostics refers to assay development and optimization, which isn't sample-size driven in the same way.
How the ground truth for the training set was established: See point 8.

Summary of what is present in the document relevant to the assertion of continued performance:

The basis of acceptance for this 510(k) submission (K243725) is that the modifications to the BD Vaginal Panel (specifically, the software update to allow result masking) do not compromise the established performance of the predicate device. The detailed performance data, acceptance criteria, study designs, and ground truth methodologies would be found in the original and subsequent predicate device submissions (DEN160001, K191957, K201017, K223653). The current submission serves to inform the FDA that a software change introducing result masking does not require new efficacy studies because it does not alter the underlying test's analytical or clinical capability to detect the specified targets.

Summary

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December 19, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Becton, Dickinson and Company Joseph Basore Staff Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152

Re: K243725

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: November 22, 2024 Received: December 3, 2024

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

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Sincerely,

Bryan M. Digitally signed by
Bryan M. Bryan M. Grabias -S Grabias -S 12:29:18-05'00'

Bryan Grabias, Ph. D. Acting 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

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Indications for Use

510(k) Number (if known) K243725

Device Name BD Vaginal Panel; BD MAX™ Vaginal Panel

Indications for Use (Describe)

· Bacterial vaginosis (BV) markers (Individual markers are not reported)
- o Lactobacillus spp. (L. crispatus and L. jensenii)
- o Gardnerella vaginalis
- o Atopobium vaginae
- o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
- o Megasphaera-1
· Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups)

o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)

o Candida glabrata
o Candida krusei
· Trichomonas vaginalis (TV)

The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.

· Bacterial vaginosis markers (Individual markers not reported)
- o Lactobacillus spp. (L. crispatus and L. jensenii)
- o Gardnerella vaginalis
- o Atopobium vaginae
- o Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
- o Megasphaera-1
· Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups)
- o Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis)
- o Candida glabrata
- o Candida krusei

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• Trichomonas vaginalis (TV)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

BD Vaginal Panel

Summary Preparation Date:

11/22/2024

Submitted by:

BD 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™ System, BD MAXTM System

For the assay: BD Vaginal Panel, BD MAXTM Vaginal Panel

Common Names:

For the instrument: High-throughput molecular system

Bacterial Vaginosis Assay For the 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)

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Product Code(s):

POA Vaginitis and Bacterial Vaginosis Nucleic Acid Detection System
OUY Trichomonas vaginalis Nucleic Acid Amplification Test System
Real Time Nucleic Acid Amplification System 00I
Instrumentation for Clinical Multiplex Test Systems NSU

Predicate Device

BD Vaginal Panel (DEN160001, K191957, K201017, K223653)

Device Establishment

Registration Number: 1119779

Intended Use

BD Vaginal Panel (For use with BD COR™ System)

Bacterial vaginosis (BV) markers (Individual markers are not reported) ●
- Lactobacillus spp. (L. crispatus and L. jensenii)
- Gardnerella vaginalis
- Atopobium vaginae ●
- Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) ●
- Megasphaera-1 ●
Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups) ●
- Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) ●
- Candida glabrata ●
- Candida krusei .
Trichomonas vaginalis (TV) .

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The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.

BD MAX™ Vaginal Panel

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 of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and/or Trichomonas vaginalis. 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 (BV) markers (Individual markers are not reported) ●
- Lactobacillus spp. (L. crispatus and L. jensenii)
- Gardnerella vaginalis ●
- Atopobium vaginae ●
- Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
- Megasphaera-1 ●
Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups) ●
- Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis)
- Candida glabrata
- Candida krusei ●
Trichomonas vaginalis ●

The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. 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.

Special Conditions for Use Statement: For Prescription Use Only

Special Instrument Requirements: BD COR™ System, BD MAX™ System

Device Description

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Bacterial vaginosis (based on detection of Lactobacillus spp. (L. crispatus and L. . jensenii), Gardnerella vaginalis, Atopobium vaginae, Bacterial Vaginosis Associated Bacteria-2, and Megasphaera-1)
Candida spp. (C. albicans, c. tropicalis, C. parapsilosis, and C. dubliniensis) .
Candida glabrata ●
Candida krusei ●
Trichomonas vaginalis ●

Test Principle

The BD Vaginal Panel is designed for use with the BD Molecular Swab Collection Kit. Samples are transported to the testing laboratory in Sample Buffer Tubes. The Sample Buffer Tubes are vortexed to release cells from the swab into the buffer, after which they are loaded on the BD MAX™ System or the BD COR™ System, along with instrument-specific consumables. No further operator intervention is necessary, and the following automated procedures occur. The bacterial cells are lysed, and DNA is extracted, captured, and concentrated on magnetic beads. After an elution step, the DNA solution is added to reagents containing specific primers and probes used to amplify and detect the genetic targets if present. After reconstitution, the instrument dispenses a fixed volume of PCR-ready solution containing extracted nucleic acids into the PCR Cartridge. Microvalves in the cartridge are sealed by the system prior to initiating PCR to contain the amplification mixture and thus prevent evaporation and contamination. Upon amplification, signal detection and interpretation are performed automatically by the instrument using real time PCR. The Extraction reagent includes a Sample Processing Control, which monitors the integrity of the reagents as well as the process steps involved in DNA extraction, amplification, and detection, and checks for the presence of potential assay inhibitors.

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.

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Probes labeled with different fluorophores are used to detect the target analytes in different optical channels of the instrument. 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 amount of fluorescence detected in the optical channels used for the BD Vaginal Panel is directly proportional to the quantity of the corresponding probe that is hydrolyzed. The instrument 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).

The BD Vaginal Panel is divided into two Master Mixes, as described below.

The Vaginitis Master Mix contains reagents for detection of the following targets: .
- Candida spp (C. albicans, C. tropicalis, C. parapsilosis and C. dubliniensis) ●
- Candida glabrata
- Candida krusei
- Trichomonas vaginalis
The Vaginosis Master Mix contains reagents for detection of the following . bacterial vaginosis markers:
- Gardnerella vaginalis ●
- Lactobacillus crispatus and Lactobacillus jensenii ●
- Atopobium vaginae ●
- Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) ●
- Megasphaera-1 ●

Substantial Equivalence1

Table 1 provides the similarities and differences between the submitted device and the legally marketed predicate device.

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 of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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BD Diagnostic Solutions

Items	Predicate - BD Vaginal Panel(K223653)	Subject -BD MAX Vaginal Panel	Subject - BD Vaginal Panel (For usewith BD CORT™ System)
Regulation	866.3975	Same	Same
Product Code	PQA, OUY, OOI, NSU	Same	Same
Device Class	II	Same	Same
Intended Use	The BD Vaginal Panel is an automatedqualitative in vitro diagnostic test for thedirect detection of DNA targets frombacteria associated with bacterialvaginosis (qualitative results reportedbased on detection and quantitation oftargeted organism markers), Candidaspecies associated with vulvovaginalcandidiasis, and Trichomonas vaginalisfrom vaginal swabs in patients who aresymptomatic for vaginitis/vaginosis. Thetest utilizes real-time polymerase chainreaction (PCR) for the amplification ofspecific DNA targets and utilizesfluorogenic target-specific hybridizationprobes to detect and differentiate DNAfrom:	The BD MAX™ Vaginal Panelperformed on the BD MAX™ System isan automated qualitative in vitrodiagnostic test for the direct detection ofDNA targets from bacteria associatedwith bacterial vaginosis (qualitativeresults reported based on detection and oftargeted organism markers), Candidaspecies associated with vulvovaginalcandidiasis, and/or Trichomonasvaginalis . The test utilizes real-timepolymerase chain reaction (PCR) for theamplification of specific DNA targets andutilizes fluorogenic target-specifichybridization probes to detect anddifferentiate DNA from:	The BD Vaginal Panel is an automatedqualitative in vitro diagnostic test for thedirect detection of DNA targets frombacteria associated with bacterialvaginosis (qualitative results reportedbased on detection and quantitation oftargeted organism markers), Candidaspecies associated with vulvovaginalcandidiasis, and/or Trichomonasvaginalis . The test utilizes real-timepolymerase chain reaction (PCR) for theamplification of specific DNA targets andutilizes fluorogenic target-specifichybridization probes to detect anddifferentiate DNA from:
	• Bacterial vaginosis markers(Individual markers not reported)○ Lactobacillus spp. ( L.crispatus and L. jensenii )○ Gardnerella vaginalis○ Atopobium vaginae○ Bacterial VaginosisAssociated Bacteria-2○(BVAB-2)○ Megasphaera-1	• Bacterial vaginosis (BV) markers(Individual markers are not reported)○ Lactobacillus spp. ( L.crispatus and L. jensenii )○ Gardnerella vaginalis○ Atopobium vaginae○ Bacterial VaginosisAssociated Bacteria-2○(BVAB-2)○ Megasphaera-1	• Bacterial vaginosis (BV) markers(Individual markers are not reported)○ Lactobacillus spp. ( L.crispatus and L. jensenii )○ Gardnerella vaginalis○ Atopobium vaginae○ Bacterial VaginosisAssociated Bacteria-2○(BVAB-2)○ Megasphaera-1
Items	Predicate - BD Vaginal Panel(K223653)	Subject -BD MAX Vaginal Panel	Subject - BD Vaginal Panel (For usewith BD CORTM System)
	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 MAXTM System or the BD CORTM System.	Vulvovaginal candidiasis (VVC) markers (markers are reported in the following groups) Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C.dubliniensis) Candida glabrata Candida krusei Trichomonas vaginalis (TV) The assay may be used to detect BV, VVC, and/or TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. The BD MAXTM 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.	Vulvovaginal candidiasis (VVC) markers (Markers are reported in the following groups) Candida spp. (С. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) Candida glabrata Candida krusei Trichomonas vaginalis (TV) The assay may be used to detect DNA associated with BV, VVC, and TV, or a subset of these conditions per clinician order, in vaginal swab specimens collected from patients who are symptomatic for vaginitis/vaginosis. 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 MAXTM System or the BD CORTM System.
Indications for Use	Symptomatic patients	Same	Same
Specimen Type	Clinician and patient-collected female vaginal swab	Same	Same
Collection/ TransportDevice	BD Molecular Swab Collection Kit	Same	Same
Technology	PCR	Same	Same
Items	Predicate - BD Vaginal Panel (K223653)	Subject -BD MAX Vaginal Panel	Subject - BD Vaginal Panel (For use with BD CORT™ System)
Organisms Detected	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	Same	Same
Sample Prep/ Results	BD MAX™ System or BD CORT™ System	BD MAX™ System	BD CORT™ System
Assay Controls	Sample Processing Control	Same	Same
Target Detection	Channel – Dyes	Targets
	ROX	Vaginitis MMCandida group1	Vaginosis MMLactobacillus crispatus/jensenii
	FAM	Trichomonas vaginalis	Atopobium vaginae
	VIC – Cal Fluor Orange 560	Candida glabrata	Megasphaera a-1/ BVAB-2
Items	Predicate - BD Vaginal Panel(K223653)	Subject -BD MAX Vaginal Panel	Subject - BD Vaginal Panel (For usewith BD COR™ System)
	Cy5 –Quasar670
	Candidakrusei
	Gardnerellavaginalis
	Cy5.5 –Quasar705
	SPC
	SPC
	1Candida group includes: C. albicans, C.parapsilosis, C. tropicalis, and C.dubliniensis
Extraction	Magnetic affinity beads with lyticase	Same	Same
On-board lysis	On-board lysis of all specimens	Same	Same
Results Metric	Ct score, SDPA, cycEP	Same	Same
Results on BD CORTMor BD MAXTM System	Assay ResultReported		Same	Same
	Result
	TV POS	Trichomonas vaginalisDNA Detected
	TV NEG	No Trichomonasvaginalis DNA Detected
	TV UNR	Unresolved – inhibitorysample or reagentfailure; no target orSample ProcessingControl amplification
Items	Predicate - BD Vaginal Panel(K223653)	Subject -BD MAX Vaginal Panel	Subject - BD Vaginal Panel (For usewith BD COR™ System)
Cgroup POS	Candida group DNADetected(C. albicans and/or C.tropicalis and/or C.parapsilosis and/or C.dubliniensis)
Cgroup NEG	No Candida group DNADetected(No C. albicans, C.tropicalis, C.parapsilosis, or C.dubliniensis)
Cgroup UNR	Unresolved – inhibitorysample or reagentfailure; no target orSample ProcessingControl amplification
Cgla POS	Candida glabrata DNADetected
Cgla NEG	No Candida glabrataDNA Detected
Cgla UNR	Unresolved – inhibitorysample or reagentfailure; no target or
Items	Predicate - BD Vaginal Panel(K223653)	Subject -BD MAX Vaginal Panel	Subject - BD Vaginal Panel (For usewith BD CORT™ System)
	Sample ProcessingControl amplification
Ckru POS	Candida krusei DNADetected
Ckru NEG	No Candida krusei DNADetected
Ckru UNR	Unresolved – inhibitorysample or reagentfailure; no target orSample ProcessingControl amplification
BV POS	Vaginosis Panel DNAdetected.
	(Detection of markercombinations related tobacterial vaginosis:Gardnerella vaginalis,and/or L. crispatus,and/or L. jensenii, and/orAtopobium vaginae,and/or BVAB-2, and/orMegasphaera-1)
BV NEG	Detection of markercombinations related tonormal vaginal flora
Items	Predicate - BD Vaginal Panel(K223653)	Subject -BD MAX Vaginal Panel	Subject - BD Vaginal Panel (For usewith BD CORT™ System)
	BV UNR
	Unresolved - inhibitorysample or reagentfailure; no target orSample ProcessingControl amplification
	IND
	Indeterminate result dueto BD MAX™ Systemfailure (with error oralert messages)
	INC
	Incomplete Run (witherror or alert messages)
Results Reported	For all specimens:1. BV + TV + VVC	One of the following, based on clinicianorder:1. BV + TV + VVC2. BV + TV3. BV + VVC4. TV + VVC5. BV6. TV7. VVC	One of the following, based on clinicianorder:1. BV + TV + VVC2. BV + TV3. BV + VVC4. TV + VVC5. BV6. TV7. VVC

Table 1: Comparison to Predicate Device

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BD Diagnostic Solutions

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BD Diagnostic Solutions

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BD Diagnostic Solutions

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BD Diagnostic Solutions

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BD Diagnostic Solutions

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BD Diagnostic Solutions

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Analytical and Clinical Performance

The clinical utility of the Vaginal Panel is unchanged from the clinical utility described in DEN160001. BD has determined that introducing the capability to order a subset of the conditions evaluated by the Vaginal Panel while masking the results for those conditions that are not ordered has no clinical impact. Currently, the BD Vaginal Panel tests for all three common causes of vaginitis / vaginosis (BV, VVC, and TV). Enabling the assay to report results for only a subset of the conditions does not change the specimen type, the test conditions, or the logic that is used to determine whether a specimen is positive or negative for the associated condition: conditions that are not ordered are simply not reported to the user. The three conditions are biologically distinct - bacterial infection, fungal infection, and a protozoan parasite; each condition has no bearing on the other, despite resulting in very similar symptoms. Therefore, analytical and clinical performance of the assays is not impacted.

Regulation Number and Section

§ 866.3975 Device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis.

(a)
Identification. A device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis is a qualitative in vitro diagnostic device intended for the detection of microbial nucleic acid sequences in vaginal specimens collected from patients with signs and symptoms of vaginitis or bacterial vaginosis. This device is intended to aid in the diagnosis of vaginitis or bacterial vaginosis when used in conjunction with clinical signs and symptoms and other laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) Documentation with a detailed device description of device components; ancillary reagents required but not provided; and explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.
(ii) Documentation with information that demonstrates the performance characteristics of the device, including:
(A) Limit of Detection;
(B) Precision (reproductivity);
(C) Analytical specificity;
(D) Analytical reactivity (inclusivity);
(E) Specimen stability; and
(F) Effects of interfering substances.
(iii) Detailed documentation from a prospective clinical study. As appropriate to the intended use, the prospective clinical study must be performed on an appropriate study population, including women of various ages and ethnicities. The prospective clinical study must compare the device performance to results obtained from well-accepted comparator methods.
(iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed explanation of the interpretation of results and acceptance criteria;
(ii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, clinical performance stratified by patient demographics such as race, ethnicity, age, and pregnancy status.
(iii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, a summary of device results in an asymptomatic population with demographic characteristics appropriate to the intended use population.
(iv) For devices with an intended use that includes detection of either Candida species or bacteria associated with bacterial vaginosis, a limitation that
Candida species and bacterial compositions associated with bacterial vaginosis can be present as part of normal vaginal flora and results should be considered in conjunction with available clinical information.