# K050755: Modification to Bvblue

- Pathway: 510(k) (Special)
- Applicant: Gryphus Diagnostics, LLC
- Decided: Apr 6, 2005 after 14 days
- Product code: MXB (Test, Vaginal, Bacterial Sialidase)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 9, 2024 · Class II · Z-1311-2024: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 

## Indications for use
BVBLUE® is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerellavaginal/s, Bacteroides spp., Prevotella spp., and Mobiluncus spp. BVBLUE is indicated for use in women suspected of having Bacterial Vaginosis (BV) infection, e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid in the diagnosis of BV infection. BVBLUE test results should be considered in conjunction with other clinical and patient information (see Limitations of the Procedure). For In Vitro Diagnostic Use Only. BVBLUE is indicated for professional use only and may be used at the point of care and/or physician's offices. It is not intended for home-use.

Source page: https://510kreport.com/device/K050755
Methodology: https://510kreport.com/methodology