Cleared Traditional

K163184 - cobas CT/NG v2.0 Test

K163184 is the FDA 510(k) clearance for cobas CT/NG v2.0 Test by Roche Molecular Systems, Inc.. It is a Class 2 Microbiology device (product code LSL) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K163184 · Roche Molecular Systems, Inc. · Microbiology device
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Feb 2017
Decision
87d
Days
Class 2
Risk

K163184 is an FDA 510(k) clearance for the cobas® CT/NG v2.0 Test. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 9, 2017 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Molecular Systems, Inc. devices

Submission Details

510(k) Number K163184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date February 09, 2017
Days to Decision 87 days
Submission Type Traditional
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
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSL Dna-reagents, Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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 - LSL Dna-reagents, Neisseria

All 35
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K163184.
Aptima Combo 2 Assay (Panther System)
K180681 · Hologic, Inc. · Jun 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · Roche Molecular Systems, Inc. · Mar 2018
Xpert CT/NG
K173840 · Cepheid · Mar 2018
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · Becton, Dickinson & CO · May 2014
COBAS CT/NG V2.0 TEST
K140887 · Roche Molecular Systems, Inc. · May 2014
COBAS CT/NG V2.0 TEST
K132270 · Roche Molecular Systems, Inc. · Dec 2013