Cleared Traditional

K222379 - Alinity m STI Assay (FDA 510(k) Clearance)

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

K222379 · Abbott Molecular, Inc. · Microbiology device
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Mar 2023
Decision
210d
Days
Class 2
Risk

K222379 is an FDA 510(k) clearance for the Alinity m STI Assay. Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on March 3, 2023 after a review of 210 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3393 - 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.

View all Abbott Molecular, Inc. devices

Submission Details

510(k) Number K222379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2022
Decision Date March 03, 2023
Days to Decision 210 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
108d slower than avg
Panel avg: 102d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3393
Definition A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.
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.

Regulatory Peers - QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

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