Cleared Traditional

simpli-COLLECT STI Test

K243410 · Abbott Molecular · Microbiology
Jan 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K243410 is an FDA 510(k) clearance for the simpli-COLLECT STI Test, a System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home (Class II — Special Controls, product code QYA), submitted by Abbott Molecular (Des Plaines, US). The FDA issued a Cleared decision on January 30, 2025, 90 days after receiving the submission on November 1, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3385.

Submission Details

510(k) Number K243410 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2024
Decision Date January 30, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QYA — System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3385
Definition This Device Is An In Vitro Diagnostic System Intended For Self-collecting Specimens In Home Settings Or Similar Environments And Testing In A Clinical Laboratory For Detection Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Sexually Transmitted Infections. The Device Is Intended For Prescription Use Or Over-the-counter Use.