21 C.F.R. § 862.1030

Current through September 30, 2024
Section 862.1030 - Alanine amino transferase (ALT/SGPT) test system
(a)Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
(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. §862.1030

52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000