21 CFR 866.2420 — Device, Oxidase Test For Gonorrhea

Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2420

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.

Classification Rationale

Class III (premarket approval) (transitional device).

Product Codes