# K243410: simpli-COLLECT STI Test

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Molecular
- Decided: Jan 30, 2025 after 90 days
- Product code: QYA (System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home)
- Device class: 2
- Regulation: 21 CFR 866.3385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200070 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200070: Simple 2 Test, Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) (2023) Summary page 7.

## Indications for use
The simpli-COLLECT STI Test is a test system intended for in vitro detection and identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) in home-collected specimens. The specimens are shipped to a clinical laboratory for testing using the Alinity m STI Assay with the automated Alinity m System for the direct, qualitative detection and differentiation of ribosomal RNA from CT, DNA from NG, ribosomal RNA from TV, and ribosomal RNA from MG, to aid in the diagnosis of disease(s) caused by infection from these organisms. The assay may be used to test the following self-collected specimens from symptomatic and asymptomatic individuals for the following analytes: • CT: vaginal swabs, female urine and male urine • NG: vaginal swabs, female urine, and male urine • TV: vaginal swabs, female urine and male urine • MG: vaginal swabs and male urine The simpli-COLLECT STI Test contains all the necessary components for the self-collection and transport of urine from male and female patients (simpli-COLLECT Urine Collection Kit) or vaginal swabs from female patients (simpli-COLLECT Swab Collection Kit) in their home, or in similar environments. The simpli-COLLECT Collection Kits may also be used to self-collect specimens in a clinic.

Source page: https://510kreport.com/device/K243410
Methodology: https://510kreport.com/methodology