Section 862.1780 - Urinary calculi (stones) test system(a)Identification. A urinary calculi (stones) test system is a device intended for the analysis of urinary calculi. Analysis of urinary calculi is used in the diagnosis and treatment of calculi of the urinary tract.(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9 .52 FR 16122, May 1, 1987, as amended at 65 FR 2308 , Jan. 14, 2000