simpli-COLLECT STI Test

The simpli-COLLECT STI Test is a home collection system for detecting Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium in self-collected urine and vaginal swab specimens. Patients collect specimens at home using provided kits, ship them to a clinical laboratory, and testing is performed using the Alinity m STI Assay on the automated Alinity m System to aid in diagnosis of sexually transmitted infections.

The device uses real-time reverse transcription-PCR (RT-PCR) for nucleic acid detection, compared to the predicate's target capture/transcription-mediated amplification technology. It employs the Alinity m System instrument rather than the Panther System. The assay includes internal controls, negative controls, and positive controls, with results reported as positive, negative, or invalid (versus the predicate's equivocal category). It detects four organisms compared to the predicate's two, and allows a lower minimum user age of 14 years versus 18 years.

Not stated in this summary.

The substantial equivalence argument rests on the fact that there are no changes to the Alinity m STI assay reagents, sample processing, assay procedure, or data reduction compared to the previously cleared K202977, so prior precision, sensitivity, and specificity studies remain valid. The key difference is the collection kit system (simpli-COLLECT) rather than the assay itself. Human factors studies demonstrated lay users can successfully collect and ship specimens with minimal error using the new kits. The predicate device (Simple 2 Test) also uses home-collected specimens shipped to a laboratory for centralized testing, establishing functional equivalence in the specimen collection and transport pathway despite differences in underlying assay technology and organism targets.