Onclarity™ Self-Collection Kit

The Onclarity Self-Collection Kit is a prescription device for self-collection of vaginal specimens in a home or private setting. The kit contains a flocked swab and either a plastic sheath (Manual Workflow) or a collection tube (Automated Workflow) for transport of the dry specimen to a laboratory for testing with the FDA-approved BD Onclarity HPV Assay.

The device uses a flocked nylon swab with a copolyester shaft, featuring perpendicular nylon fibers at the tip. Key differences from the predicate (Teal Wand) include: rotation duration of 10-30 seconds versus 10 rotations; 36-month shelf-life versus 12 months; inclusion of standardized collection tubes and biohazard bags; and support for both Manual Workflow (dry transport) and Automated Workflow (with collection tube).

Not stated in this summary.

The Onclarity Self-Collection Kit is substantially equivalent to the Teal Wand predicate because both devices share the same intended use (self-collection of vaginal specimens for HPV testing), regulation (21 CFR 866.2920), product code (SEP), collection type and setting, and prescription requirement. Clinical studies demonstrate comparable analytical and clinical performance, with high positive and negative percent agreement between self-collected vaginal and clinician-collected cervical specimens.