Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

The Dochek® Fentanyl Urine Test System is a rapid immunochromatographic assay for qualitative detection of fentanyl in human urine at a cutoff of 1 ng/mL. It is available in three formats (strip, card, and cup), intended for in vitro diagnostic use only as a preliminary screening test, with results requiring confirmatory testing by GC/MS or LC/MS. The non-Plus versions are over-the-counter (OTC) use; the Plus versions do not specify OTC designation.

The device uses competitive binding and lateral flow immunochromatographic methodology on an absorbent substrate. The Strip, Card, and Cup versions all use identical test strips with the same chemical formulation and manufacturing procedures, differing only in physical configuration. Storage is 2–30°C with 24-month shelf life. The predicate (K231698) is a cassette-based device, whereas these formats offer strip, card, and cup alternatives.

Not stated in this summary.

Substantial equivalence is based on identical test principle (competitive binding immunoassay), same specimen type (urine), identical cutoff concentration (1 ng/mL), qualitative results, and equivalent methodology (lateral flow immunochromatography). Precision and method comparison studies show 97.5% agreement with LC-MS across three lots. Lay-user studies demonstrate 92.5–100% accuracy across concentration ranges. Analytical specificity and cross-reactivity data demonstrate appropriate sensitivity to fentanyl and related compounds. Although the configuration differs from the predicate cassette, the underlying immunochemical assay mechanism, analytical performance, and clinical function are equivalent, supporting OTC and professional use as claimed.