Cleared Traditional

K243410 - simpli-COLLECT STI Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K243410 is an FDA 510(k) clearance for the simpli-COLLECT STI Test. Classified as System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home (product code QYA), Class II - Special Controls.

Submitted by Abbott Molecular (Des Plaines, US). The FDA issued a Cleared decision on January 30, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3385 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K243410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.