Section 862.1460 - Leucine aminopeptidase test system(a)Identification. A leucine aminopeptidase test system is a device intended to measure the activity of the enzyme leucine amino-peptidase in serum, plasma, and urine. Leucine aminopeptidase measurements are used in the diagnosis and treatment of liver diseases such as viral hepatitis and obstructive jaundice.(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 2307 , Jan. 14, 2000