Cleared Traditional

K173887 - cobas CT/NG for use on cobas 6800/8800 ...

K173887 is an FDA 510(k) clearance for cobas CT/NG for use on cobas 6800/8800 ..., manufactured by Roche Molecular Systems, Inc.. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K173887 · Roche Molecular Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
90d
Days
Class 2
Risk

K173887 is an FDA 510(k) clearance for the cobas CT/NG for use on cobas 6800/8800 systems. 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 March 21, 2018 after a review of 90 days - within the typical 510(k) review window.

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: 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 - K173887

510(k) Number K173887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2017
Decision Date March 21, 2018
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSL Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K173887.
Aptima Neisseria gonorrhoeae Assay
K231329 · Hologic, Inc. · Jan 2024
Aptima Combo 2 Assay (Panther System)
K180681 · Hologic, Inc. · Jun 2018
Xpert CT/NG
K173840 · Cepheid · Mar 2018
cobas® CT/NG v2.0 Test
K163184 · Roche Molecular Systems, Inc. · Feb 2017
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