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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.

The BVBLUE™ Test contains a chromogenic substrate of sialidase enzyme, IBX-4041. The chromogenic substrate is provided in each of the BVBLUE™ Testing Vessels as a solution containing 0.25 mg IBX-4041 in 0.5 mL aqueous potassium acetate solution (49.0 mg/mL; 0.5 M, pH 5.5-6.0). When the solution containing the solubilized chromogenic substrate is exposed to sialidase enzyme, the substrate is hydrolyzed to yield sialic acid and IBX-4050. Upon the addition of one of more drops of the BVBLUE™ Developer Solution [an aqueous sodium hydroxide solution (40 mg/mL; 1.0 M; pH>11.0)], IBX-4050 exhibits an intense blue color. In the absence of sialidase enzyme, the chromogenic substrate is not hydrolyzed and exhibits a vellow color upon the addition of one or more drops of the BVBLUE'M Developer Solution.

Materials Provided:
10 BVBLUE™ Units per Package:

• Ten (10) BVBLUE™ Testing Vessels each containing 0.25 mg IBX-4041 . component in 0.5 mL of an aqueous potassium acetate buffer solution (49.0 mg/mL; 0.5 M; pH 5.5-6.0).
• One (1) BVBLUE™ Developer Solution Tube containing 0.5 mL of an . aqueous sodium hydroxide solution (40.0 mg/mL; 1.0 M; pH>11.0).
• Instructions for Use .

Here's a detailed breakdown of the acceptance criteria and study information for the BVBLUE™ device, based on the provided text:

BVBLUE™ Device: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with specific numerical targets prior to presenting results. Instead, performance metrics are reported, and the conclusion states that these demonstrate substantial equivalence. Based on the provided performance numbers, the implied acceptance criteria would be those achieved or exceeded in the studies.

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