# K173887: cobas CT/NG for use on cobas 6800/8800 systems

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Mar 21, 2018 after 90 days
- Product code: LSL (Dna-Reagents, Neisseria)
- Device class: 2
- Regulation: 21 CFR 866.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003395 (2001). 13 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163184: cobas® CT/NG v2.0 Test, Roche Molecular Systems, Inc. (2017) Summary page 5.

## Most influential descendants
- K202408: cobas CTNG for use on cobas 6800/8800 systems (2021), 3 descendants of its own
- K260917: cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (2026), 0 descendants of its own
- K253759: cobas liat CT/NG/MG nucleic acid test (2026), 0 descendants of its own
- K253756: cobas liat CT/NG nucleic acid test (2026), 0 descendants of its own
- K240217: cobas® liat CT/NG nucleic acid test (2025), 0 descendants of its own

## Indications for use
The cobas® CT/NG on the cobas® 6800/8800 system is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals. Ancillary Collection Kits: The cobas® PCR Media Dual Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens. Note: This kit has been validated for use with the following tests: • cobas® CT/NG v2.0 Test • cobas® CT/NG for use on cobas® 6800/8800 Systems The cobas® PCR Media Uni Swab Sample Kit is used to collect and transport human specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for human specimens. Note: This kit has been validated for use with the following tests: • cobas® CT/NG v2.0 Test • cobas® CT/NG for use on cobas® 6800/8800 Systems • cobas® Cdiff Test for use on the cobas® 4800 System The cobas® PCR Urine Sample Kit is used to collect and transport urine specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium for urine specimens. Use this collection kit only with either cobas® CT/NG on cobas® 6800/8800 Systems or the cobas® CT/NG v2.0 Test.

Source page: https://510kreport.com/device/K173887
Methodology: https://510kreport.com/methodology