Cleared Dual Track

cobas? liat CT/NG nucleic acid test

K240217 · Roche Molecular Systems, Inc. · Microbiology

Jan 2025

Decision

357d

Days

Class 2

Risk

About This 510(k) Submission

K240217 is an FDA 510(k) clearance for the cobas? liat CT/NG nucleic acid test, a Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (Class II — Special Controls, product code QEP), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 17, 2025, 357 days after receiving the submission on January 26, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3393.

Submission Details

510(k) Number	K240217 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 2024
Decision Date	January 17, 2025
Days to Decision	357 days
Submission Type	Dual Track
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.