Safecare Urinary Tract Infection Test

The Safecare Urinary Tract Infection Test is an in vitro diagnostic device that qualitatively detects leukocytes (white blood cells) and nitrite in urine to aid in screening for urinary tract infections. It is intended for over-the-counter home use and consists of two-color pads on a strip that are read visually by comparing color changes to a reference chart.

The device uses the same test methodologies as the predicate: nitrite detection via conversion of nitrate to nitrite using an acid medium and diazonium compound coupling to produce a pink color, and leukocyte detection via hydrolysis of an indoxyl ester derivative by leukocyte esterase to produce a colored compound. The specimen type, testing parameters, conditions of use, and 2-minute read time are identical to the predicate device K231045.

Not stated in this summary.

The device is substantially equivalent because it uses identical test principles, methodology, and performance characteristics as the predicate device Healgen URS Test Strips (K231045). Clinical testing demonstrated equivalent precision and reproducibility across three sites, analytical specificity with no interference from specified substances at stated concentrations, assay cut-offs matching the predicate, and lay-user performance with 100% agreement on nitrite results (154 subjects) and 88.89%–100% agreement on leukocyte results across four grading levels.