[Title 21 CFR 862.1155]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES]
[Subpart B - Clinical Chemistry Test Systems]
[Sec. 862.1155 - Human chorionic gonadotropin (HCG) test system.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01false862.1155Sec. 862.1155FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESCLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICESClinical 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 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.