# K202408: cobas CTNG for use on cobas 6800/8800 systems

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jan 21, 2021 after 153 days
- Product code: QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections)
- Device class: 2
- Regulation: 21 CFR 866.3393
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003395 (2001). 14 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173887: cobas CT/NG for use on cobas 6800/8800 systems, Roche Molecular Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The cobas® CT/NG for use on the cobas® 6800/8800 Systems 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), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal 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 human specimens. The cobas® PCR Media serves as a nucleic acid stabilizing transport and storage medium. Note: This kit has been validated for use with the following tests: • cobas® CT/NG v2.0 Test (for use on the cobas® 4800 Systems) • cobas® CT/NG for use on cobas® 6800/8800 Systems • cobas® TV/MG for use on the 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. Note: This kit has been validated for use with the following tests: • cobas® CT/NG v2.0 Test (for use on the cobas® 4800 Systems) • cobas® CT/NG for use on cobas® 6800/8800 Systems • cobas® TV/MG for use on the 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. Note: This kit has been validated for use with the following tests: • cobas® CT/NG v2.0 Test (for use on cobas® 4800 Systems) • cobas® CT/NG for use on cobas® 6800/8800 Systems • cobas® TV/MG for use on the cobas® 6800/8800 Systems

Source page: https://510kreport.com/device/K202408
Methodology: https://510kreport.com/methodology