[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: 21CFR862.1245]

[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. 862.1245  Dehydroepiandrosterone (free and sulfate) test system.

    (a) Identification. A dehydroepiandrosterone (free and sulfate) test 
system is a device intended to measure dehydroepiandrosterone (DHEA) and 
its sulfate in urine, serum, plasma, and amniotic fluid. 
Dehydroepiandrosterone measurements are used in the diagnosis and 
treatment of DHEA-secreting adrenal carcinomas.
    (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 2306, Jan. 14, 2000]