# K993732: Bvblue

- Pathway: 510(k) (Traditional)
- Applicant: Gryphus Diagnostics, LLC
- Decided: May 15, 2000 after 193 days
- Product code: MXB (Test, Vaginal, Bacterial Sialidase)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923133 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923133: Affirm/VP Ident.Test G.Vaginalis & T.Vaginalis, Microprobe Corp. (1992) Summary page 1.
- K964015: Indicard Test, Litmus Concepts, Inc. (1997) Summary page 1.
- K962718: Femexam Testcard, Litmus Concepts, Inc. (1997) Summary page 1.

## 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 Gardnerella vaginalis, 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 in physician’s offices. It is not intended for home use.

Source page: https://510kreport.com/device/K993732
Methodology: https://510kreport.com/methodology