[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: 21CFR862.1155]

[Page 197-198]
 
                        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. 862.1155  Human chorionic gonadotropin (HCG) test system.

    (a) Human chorionic gonadotropin (HCG) test system intended for the 
early detection of pregnancy--(1) Identification. A human chorionic 
gonadotropin (HCG) test system is a device intended for the early 
detection of pregnancy is intended to measure HCG, a placental hormone, 
in plasma or urine.
    (2) Classification. Class II.
    (b) Human chorionic gonadotropin (HCG) test system intended for any 
uses

[[Page 198]]

other than early detection of pregnancy--(1) Identification. A human 
chorionic goadotropin (HCG) test system is a device intended for any 
uses other than early detection of pregnancy (such as an aid in the 
diagnosis, prognosis, and management of treatment of persons with 
certain tumors or carcinomas) is intended to measure HCG, a placental 
hormone, in plasma or urine.
    (2) Classification. Class III.
    (3) Date PMA or notice of completion of a PDP is required. As of the 
enactment date of the amendments, May 28, 1976, an approval under 
section 515 of the act is required before the device described in 
paragraph (b)(1) may be commercially distributed. See Sec. 862.3.