21 CFR 866.3386 — Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users

Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3386

Identification

The Visby Medical Women’s Sexual Health Test is a single-use (disposable), automated, rapid, compact device containing a PCR-based assay for the direct qualitative detection and differentiation of DNA from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal swab specimens. It is intended to be sold over-the-counter (OTC) for use by females suspected of sexually transmitted infection.

Classification Rationale

Class II (special controls). The device is classified under 21 CFR 866.3386, Test for detection of microorganism(s) causing sexually transmitted infections performed by lay users.

Product Codes