Healgen® URS Test Strips

The Healgen® URS Test Strips are in vitro diagnostic devices for qualitative detection of leukocytes (white blood cells) and nitrite in urine to aid in screening for urinary tract infections (UTIs). The device consists of two color pads on a strip that users dip into urine or apply via midstream collection, then visually compare the color change against a color chart after 2 minutes. It is intended for over-the-counter home use only.

The device uses two independent test chemistries: leukocyte detection via hydrolysis of an indoxyl ester derivative by leukocyte esterase (producing pink-to-purple color), and nitrite detection via p-arsanilic acid conversion to a diazonium compound coupled with 1,2,3,4-tetrahydrobenzo(h)quinoline (producing pink color). Results are determined by visual comparison using minimum color distance between developed and calibration colors on the color chart.

Not stated in this summary.

The Healgen® URS Test Strips are substantially equivalent to predicate device K231045 (Healgen URS Test Strips) based on identical indications for use, specimen type, testing parameters, test methodology, read time, and detection method. Performance data demonstrated LOD of 10 cells/μL for leukocytes and 0.05 mg/dL for nitrite; 100% precision across all tested concentrations; no analytical interference at specified substance concentrations; 100% agreement on nitrite and 95.6-98.8% exact agreement on leukocytes in method comparison with predicate; and 92.9-100% lay-user agreement with healthcare professionals.