[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1210]

[Page 199-200]
 
                        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. 862.1210  Creatine test system.

    (a) Identification. A creatine test system is a device intended to 
measure creatine (a substance synthesized in the liver and pancreas and 
found in biological fluids) in plasma, serum, and urine. Measurements of 
creatine are used in the diagnosis and treatment of muscle diseases and 
endocrine disorders including hyperthyroidism.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 200]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 862.9.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 
FR 38787, July 25, 2001]