Cleared Traditional

Alinity m STI Assay

K202977 · Abbott Molecular, Inc. · Microbiology

Apr 2022

Decision

576d

Days

Class 2

Risk

About This 510(k) Submission

K202977 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 April 29, 2022, 576 days after receiving the submission on September 30, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K202977 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2020
Decision Date	April 29, 2022
Days to Decision	576 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.