[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: 21CFR866.2420]

[Page 258]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866_IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart C_Microbiology Devices
 
Sec. 866.2420  Oxidase screening test for gonorrhea.

    (a) Identification. An oxidase screening test for gonorrhea is an in 
vitro device that consists of the articles intended to identify by 
chemical reaction, cytochrome oxidase, an oxidizing enzyme that is 
associated with certain bacteria including Neisseria gonorrhoeae. A 
sample of a male's urethral discharge is obtained on a swab which is 
placed into a wetting agent containing an ingredient that will react 
with cytochrome oxidase. When cytochrome oxidase is present, the swab 
turns a dark purple color within 3 minutes. Because it is unlikely that 
cytochrome oxidase-positive organisms other than Neisseria gonorrhoeae 
are present in the urethral discharge of males, the identification of 
cytochrome oxidase with this device indicates presumptive infection of 
the patient with the causative agent of gonorrhea.
    (b) Classification. Class III (premarket approval) (transitional 
device).
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 866.3.

[47 FR 50823, Nov. 9, 1982, as amended at 52 FR 17734, May 11, 1987]