Cleared Dual Track

K253759 - cobas liat CT/NG/MG nucleic acid test (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

K253759 · Roche Molecular Systems, Inc. · Microbiology device
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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

Submission Details

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

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

All 22
Devices cleared under the same product code (QEP) and FDA review panel - the closest regulatory comparables to K253759.
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
NeuMoDx CT/NG Assay 2.0
K230267 · Neumodx Molecular, Inc. · Dec 2023