Cleared Dual Track

K253759 - cobas liat CT/NG/MG nucleic acid test

K253759 is an FDA 510(k) clearance for cobas liat CT/NG/MG nucleic acid test, manufactured by Roche Molecular Systems, Inc.. The device is a Class 2 Microbiology device with product code QEP cleared through the Dual Track 510(k) pathway after a 171-day FDA review.

K253759 · Roche Molecular Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
171d
Days
Class 2
Risk

K253759 is an FDA 510(k) clearance for the cobas liat CT/NG/MG nucleic acid test. Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 15, 2026 after a review of 171 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 Roche Molecular Systems, Inc. devices

FDA 510(k) Submission Details - K253759

510(k) Number K253759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2025
Decision Date May 15, 2026
Days to Decision 171 days
Submission Type Dual Track
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
69d slower than avg
Panel avg: 102d · This submission: 171d
Pathway characteristics

QEP Device Classification - Class 2, Special Controls

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

All 23
Devices cleared under the same product code (QEP) and FDA review panel - the closest regulatory comparables to K253759.
cobas CT/NG for use on the cobas 5800/6800/8800 systems
K260917 · Roche Molecular Systems, Inc. · Jul 2026
cobas liat CT/NG nucleic acid test
K253756 · Roche Molecular Systems, Inc. · May 2026
Visby Medical Men's Sexual Health Test
K251501 · Visby Medical, Inc. · Oct 2025
BD CTGCTV2
K243343 · Bd Integrated Diagnostic Solutions/Becton, · Apr 2025
cobas® liat CT/NG nucleic acid test
K240217 · Roche Molecular Systems, Inc. · Jan 2025
cobas® liat CT/NG/MG nucleic acid test
K240197 · Roche Molecular Systems, Inc. · Jan 2025