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510(k) Data Aggregation
(202 days)
FemLab is a biochemical assay intended for use as a screening test for nitrites, blood, protein, and proline-iminopeptidase in vaginal fluid samples, and also to measure vaginal fluid pH. It is indicated for use as an aid in the presumptive diagnosis of vaginitis or urethritis when used in conjunction with other laboratory tests such as Gram stain, microscopic examination, and clinical signs and symptoms. The FemLab Vaginitis Test Kit is for professional and laboratory use only.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "FemLab® Vaginitis Test Kit." It is not a study report, and therefore, it does not contain the detailed information requested regarding acceptance criteria, study methodologies, or performance metrics from a clinical trial.
The letter only states that the FDA has determined the device is "substantially equivalent" to legally marketed devices for the indications of use referenced. It does not provide the underlying data or studies used to make that determination.
To answer your specific questions, a clinical study report or a summary of safety and effectiveness from the 510(k) submission would be required. This document does not contain that information.
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