[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1030]

[Page 185]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES--Table of Contents
 
               Subpart B--Clinical Chemistry Test Systems
 
Sec. 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 Sec. 862.9.

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