BD Vaginal Panel

K243725 · Becton, Dickinson and Company · PQA · Dec 19, 2024 · Microbiology

Device Facts

• Record ID: K243725
• Device Name: BD Vaginal Panel
• Applicant: Becton, Dickinson and Company
• Product Code: PQA · Microbiology
• Decision Date: Dec 19, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3975
• Device Class: Class 2

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/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.

Device Story

BD Vaginal Panel; nucleic acid-based multiplex test system. Modification allows users to select specific assays for reporting based on clinician orders. Operates via clinical laboratory instrumentation; processes vaginal samples to detect specific microbial targets. Output provides diagnostic information to clinicians for patient management. Used in clinical laboratory settings by trained technicians. Modification maintains fundamental scientific technology of previously cleared device.

Clinical Evidence

No new clinical data presented. Clinical utility is unchanged from DEN160001. The manufacturer asserts that enabling result masking for subsets of conditions does not impact analytical or clinical performance, as the detection logic for each condition remains independent and unchanged.

Technological Characteristics

Real-time PCR assay; uses fluorogenic TaqMan hydrolysis probes. Automated extraction via magnetic affinity beads with lyticase. Compatible with BD MAX and BD COR systems. Software-controlled result reporting allows masking of specific targets. No changes to materials or sensing principles compared to predicate.

Indications for Use

Indicated for the detection of nucleic acid sequences from microorganisms associated with vaginitis, bacterial vaginosis, and Trichomonas vaginalis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• BD Vaginal Panel (K243725 - original clearance)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243725

B Applicant

Becton, Dickinson and Company

C Proprietary and Established Names

BD Vaginal Panel

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PQA | Class II | 21 CFR 866.3975 - Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis And Bacterial Vaginosis | MI - Microbiology |
| OUY | Class II | 21 CFR 866.3860 - Trichomonas vaginalis nucleic acid assay | MI - Microbiology |
| OOI | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |
| NSU | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change allows users to select specific assays to be reported based on the order received from the clinician.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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