21 C.F.R. § 862.1460

Current through September 30, 2024
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 .

21 C.F.R. §862.1460

52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000