BD Vaginal Panel
by Becton, Dickinson and Company 2 variants
510(k) K223653
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223653 | Date6 Mar 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PQA
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3975
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
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 provide definitive results for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV) from a single patient sample.
This in vitro diagnostic device is intended for use in microbiology laboratories and clinical settings to aid in the diagnosis of vaginitis. Supplied as a single-use test, it requires no special storage conditions beyond refrigeration and is compatible with the BD MAX™ System. The device holds FDA 510(k) clearance under the classification of Class II (PQA product code) and adheres to regulatory requirements outlined in 866.3975.
From the manufacturer
BD Vaginal Panel is a comprehensive diagnostic test that directly detects the 3 most common infectious causes of vaginitis in one test, with one swab.
take the guess work out of diagnosing the most common Vaginitis and non-viral STI infections. Get the definitive answers you need from visit one and with one patient collection.
With BD MAX™ Vaginal Panel, differentiation of C. glabrata and C.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What specific infections does the BD Vaginal Panel test for, and how does it determine the results?
The BD Vaginal Panel detects the three most common causes of vaginitis in a single test: Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). It uses a proprietary microbiome-based algorithm to analyze a patient sample, providing definitive results for all three conditions simultaneously. This eliminates the need for multiple tests and streamlines diagnosis in microbiology labs or clinical settings.
Is the BD Vaginal Panel designed for single-use or repeated testing, and what storage requirements apply?
The BD Vaginal Panel is supplied as a single-use test, meaning each device is intended for one patient sample only. No special storage conditions are required beyond standard refrigeration, ensuring stability and reliability for clinical use.
Which diagnostic systems is the BD Vaginal Panel compatible with, and how does this affect workflow?
The BD Vaginal Panel is specifically designed to work with the BD MAX™ System, an automated nucleic acid detection platform. This compatibility simplifies workflow by integrating sample processing, amplification, and result interpretation into a single, streamlined system, reducing manual handling and improving efficiency in microbiology labs.
How does the regulatory pathway for the BD Vaginal Panel differ from other diagnostic tests, and what does this imply for its use?
The BD Vaginal Panel holds FDA 510(k) clearance under the classification of Class II (PQA product code), indicating it was determined to be *substantially equivalent* to a legally marketed predicate device. This regulatory route implies it has undergone rigorous review by the FDA’s Microbiology Advisory Committee to ensure safety, effectiveness, and performance for diagnosing vaginitis and bacterial vaginosis in clinical settings.