Evidence MultiSTAT DOA Urine MultiPlex

The Evidence MultiSTAT DOA Urine MultiPlex is a qualitative drug-of-abuse screening test kit used with the Evidence MultiSTAT analyzer to detect 15 different drugs and metabolites in human urine samples at specified cut-off concentrations. It provides preliminary results requiring confirmatory testing by GC/MS or LC/MS/MS and is intended for prescription use only in laboratory settings.

The device uses Randox Biochip Array technology with immobilized antibodies in discrete test regions and a competitive chemiluminescent immunoassay format where drug in the specimen competes with horseradish peroxidase-labeled drug conjugate for antibody binding. Light signals are detected by a charge-coupled device camera and processed by analyzer software to produce qualitative results compared against cut-off materials.

Not stated in this summary.

The candidate device is substantially equivalent to its predicate (k220451) because it uses identical trade name, model number, analyzer platform, methodology (qualitative immunoassay), sample matrix (urine), and intended use (screening for drugs of abuse). The main difference is the addition of five new analytes (Tramadol, Phencyclidine, Buprenorphine, 6-Acetylmorphine, and Fentanyl) to the predicate's panel, which do not raise new safety or effectiveness concerns.