[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1030]

[Page 178-179]
 
                        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

[[Page 179]]

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]