[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: 21CFR862.1185]

[Page 189-190]
 
                        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. 862.1185  Compound S (11-deoxycortisol) test system.

    (a) Identification. A compound S (11-dioxycortisol) test system is a 
device intended to measure the level of compound S (11-dioxycortisol) in 
plasma. Compound S is a steroid intermediate

[[Page 190]]

in the biosynthesis of the adrenal hormone cortisol. Measurements of 
compound S are used in the diagnosis and treatment of certain adrenal 
and pituitary gland disorders resulting in clinical symptoms of 
masculinization and hypertension.
    (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]