510(k) · Cleared

Cleared

Bvblue

K993732510(k) TraditionalCleared May 15, 2000193-day reviewClass I21 CFR 866.2660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gryphus Diagnostics, LLC · MXB Test, Vaginal, Bacterial Sialidase

Cleared on May 15, 2000 as substantially equivalent to K923133 (Microprobe Corp., 1992) and 2 other predicates after a 193-day review. Its family tree reaches back 1 generation to 1992.

Decided: May 15, 2000
Review: 193 days
Class: Class I
Product code: MXB
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K923133 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK923133 Affirm/VP Ident.Test G.Vaginalis & T.VaginalisMicroprobe Corp. · 1992
This deviceK993732 BvblueGryphus Diagnostics, LLC · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923133	Affirm/VP Ident.Test G.Vaginalis & T.Vaginalis	Microprobe Corp.	1992	—
0 (this device)	K993732	Bvblue	Gryphus Diagnostics, LLC	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

FIG. 1 — Lineage of K993732, 1992–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K923133	Affirm/VP Ident.Test G.Vaginalis & T.Vaginalis Summary page 1 …: October 20, 1999 Name of the Device: BvBLUE™ Predicate Device Information: 1. Affirm/VP Identifiaction Test for Gardnerella vaginalis and Trichomonas vaginalis, K# 923133, Microprobe Inc. 2. Indicard® Test, K# 964015, Litmus Concepts, Inc. 3. FemExam® TestCard™ pH and Amines Tests, K# 962718, Litm…	Microprobe Corp.	1992	—
*	K964015	Indicard Test Summary page 1 …™ Predicate Device Information: 1. Affirm/VP Identifiaction Test for Gardnerella vaginalis and Trichomonas vaginalis, K# 923133, Microprobe Inc. 2. Indicard® Test, K# 964015, Litmus Concepts, Inc. 3. FemExam® TestCard™ pH and Amines Tests, K# 962718, Litmus Concepts, Inc. Device Description: The BVB…	Litmus Concepts, Inc.	1997	—
*	K962718	Femexam Testcard Summary page 1 …rella vaginalis and Trichomonas vaginalis, K# 923133, Microprobe Inc. 2. Indicard® Test, K# 964015, Litmus Concepts, Inc. 3. FemExam® TestCard™ pH and Amines Tests, K# 962718, Litmus Concepts, Inc. Device Description: The BVBLUE™ Test contains a chromogenic substrate of sialidase enzyme, IBX-4041. The…	Litmus Concepts, Inc.	1997	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.

How does its category compare?

All MXB devices

MXB 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

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code MXB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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 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…

Read the full statement (125 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993732 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993732: Bvblue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993732

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026