510(k) · Cleared
Recalled · Class II · 2024Modification to Bvblue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gryphus Diagnostics, LLC · MXB Test, Vaginal, Bacterial Sialidase
Cleared on Apr 6, 2005 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Apr 6, 2005
- Review
- 14 days
- Class
- Class I
- Product code
- MXB
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MXB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2024 | Class II | Z-1311-2024 | Storage | 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 - 8 Degrees Celsius) for up to 60… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MXB devicesMXB Test, Vaginal, Bacterial Sialidase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MXB
FDA has decided no MXB device since 2007.
Median 510(k) review, days · MXB
Too few MXB 510(k)s in any year since 2007 to give a median.
Recalls per year · MXB
No recall names MXB since 2007.
Adverse event reports per year · MXB
1in 2019
MAUDE reports naming product code MXB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (122 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050755: Modification to Bvblue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050755
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026