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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 physician's offices. It is not intended for home-use.

BVBLUE is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity.

The provided text is a 510(k) clearance letter from the FDA for a device called BVBLUE®. It discusses the regulatory classification and approval process but does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text. The document states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...", which implies a study was conducted, but none of the details of that study are present in this document.

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