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Immunoassay for the qualitative detection of methadone in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.

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This FDA document is a 510(k) clearance letter for the AccuSign® MTD device, an immunoassay for the qualitative detection of methadone in human urine. It does not contain information about the acceptance criteria or the study that proves the device meets them.

The letter explicitly states: "we have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements... and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."

This indicates that the device was cleared based on its substantial equivalence to a predicate device, not through a new clinical study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding study details (sample size, expert qualifications, adjudication, MRMC study, training set details, ground truth types) is not present in this document.

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