Cleared Traditional

Alinity m STI Assay

K222379 · Abbott Molecular, Inc. · Microbiology

Mar 2023

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K222379 is an FDA 510(k) clearance for the Alinity m STI Assay, a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II — Special Controls, product code QEP), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on March 3, 2023, 210 days after receiving the submission on August 5, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K222379 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	QEP — Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class	Class II — 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.