[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR862.1165]

[Page 181]
 
                        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. 862.1165  Catecholamines (total) test system.

    (a) Identification. A catecholamines (total) test system is a device 
intended to determine whether a group of similar compounds (epinephrine, 
norepinephrine, and dopamine) are present in urine and plasma. 
Catecholamine determinations are used in the diagnosis and treatment of 
adrenal medulla and hypertensive disorders, and for catecholamine-
secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and 
retinoblastoma).
    (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]