21 CFR 866.3986 — Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3986

Identification

The First To Know Syphilis Test is a single-use, qualitative, rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human capillary whole blood. It is intended for over-the-counter (OTC) consumer use in individuals suspected of syphilis. The test is visually read and does not require software, instrumentation, or additional reagents.

Classification Rationale

Class II (special controls). The device is classified as Class II under 21 CFR 866.3986, as general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but the risks can be mitigated by special controls.

Product Codes