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The Monitect® MDMA Drug Screen Cassette Test and the Fastect™ II Drug Screen Dipstick Test are in vitro screen tests that contains chromatographic immunoassays for the rapid detection of 3,4-Methylenedioxymethamphetamine (MDMA) in human urine above the cutoff concentration of 500 ng/mL. Both the Monitect® and Fastect™ II devices provide visual, qualitative results only. The devices are intended for in vitro diagnostic use in professional and laboratory settings only. The devices are not intended for over-the-counter sale to lay persons.

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The provided text describes a 510(k) premarket notification for two drug screen tests, Monitect® MDMA Drug Screen Cassette Test and Fastect™ II MDMA Drug Screen Dipstick Test, designed to detect MDMA in human urine. However, the document is a regulatory approval letter and an indications for use statement; it does not contain a study that proves the device meets specific acceptance criteria.

Therefore, I cannot directly extract the requested information about acceptance criteria and a detailed study from this document. The information typically found in such a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is absent from this regulatory communication.

The document only states that the FDA reviewed the 510(k) and determined the devices are substantially equivalent to legally marketed predicate devices for the stated indications for use. This determination implies that the manufacturer would have submitted data demonstrating performance, but that specific data is not included in this letter.

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