Identifiers
- 510(k) Number
- K243725 FDA 510(k)
- FDA Product Code
- PQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3975 FDA 510(k)
- Regulation Number
- 866.3975 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Vaginal Panel is a Nucleic Acid Detection System for Vaginitis and Bacterial Vaginosis, designed to identify the three most common infectious causes of vaginitis in a single test. It employs a proprietary microbiome-based algorithm to detect Bacterial Vaginosis, Vulvovaginal Candidiasis, and Trichomoniasis from a single swab sample, providing definitive diagnostic results.
This in vitro diagnostic device is intended for use in microbiology laboratories and requires processing on the BD MAX™ or BD CORTM PX/MX systems. The panel is supplied as a single-use reagent kit, with no sterility claims specified. It is classified under FDA regulation 866.3975 and holds a Special 510(k) clearance (K243725) for substantial equivalence. No MRI safety or reusable components are indicated.
Frequently asked questions
What specific infections does the BD Vaginal Panel test for, and how does it determine bacterial vaginosis?
The BD Vaginal Panel detects the three most common causes of vaginitis in a single test: Bacterial Vaginosis, Vulvovaginal Candidiasis (a fungal infection), and Trichomoniasis (a parasitic infection). It uses a proprietary microbiome-based algorithm to identify Bacterial Vaginosis by analyzing the microbial composition of the sample, rather than relying solely on a single pathogen. This approach provides a more comprehensive diagnostic result compared to traditional culture-based methods.
Is the BD Vaginal Panel designed for use in any specific laboratory equipment, and how is it supplied?
Yes, the BD Vaginal Panel is intended for use exclusively with the BD MAX™ or BD MAX™ PX/MX systems in microbiology laboratories. It is supplied as a single-use reagent kit, meaning each kit is intended for one test cycle and cannot be reused. The kit does not carry a sterility claim, so proper handling and processing protocols should be followed to ensure accurate results.
Can this panel be used repeatedly, or is it meant for one-time use per sample?
The BD Vaginal Panel is explicitly designed as a single-use reagent kit. Each kit is intended for one diagnostic test cycle only, ensuring consistency and reliability for each sample. This design eliminates the risk of cross-contamination and maintains the integrity of the test results.
What regulatory pathway was followed for the approval of the BD Vaginal Panel, and what classification does it fall under?
The BD Vaginal Panel received a Special 510(k) clearance (K243725) under the FDA’s regulatory pathway, demonstrating substantial equivalence to a predicate device. It is classified under FDA regulation 866.3975 and falls under the product code PQA, which is categorized under microbiology. This clearance indicates that the device meets the necessary safety and effectiveness standards for its intended use in diagnosing vaginitis and bacterial vaginosis.
How is the sample collected for testing with the BD Vaginal Panel, and what type of sample is required?
The BD Vaginal Panel requires a single swab sample collected from the vaginal area. The sample is then processed using the BD MAX™ or BD MAX™ PX/MX systems, which utilize nucleic acid detection technology to identify the target pathogens. The simplicity of the sample collection—just one swab—makes it convenient for clinicians while ensuring comprehensive diagnostic results.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD MAX™ Vaginal Panel - 443712 | BD, PDF Becton, Dickinson and Company March 6, 2023 Joseph Basore Staff ..., BD Vaginal Panel and BD CTGCTV2, BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243725 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K243725 24 fields · synced Oct 6, 2026