# K163184: cobas® CT/NG v2.0 Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Feb 9, 2017 after 87 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: 5 generations back to K003395 (2001). 12 ancestors in all.
7 later devices descend from it; 1 cites 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)
- K110923: Cobas 4800 CT / NG Test, Roche Molecular Systems, Inc. (2012) Summary page 4.
- K132270: Cobas CT/NG V2.0 Test, Roche Molecular Systems, Inc. (2013) Summary page 4.
- (no number) cobas® PCR Female Swab Sample Kit: named in the summary without a submission number
- (no number) cobas® PCR Urine Sample Kit: named in the summary without a submission number

## Most influential descendants
- K173887: cobas CT/NG for use on cobas 6800/8800 systems (2018), 6 descendants of its own
- 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

## Indications for use
The cobas® CT/NG v2.0 Test is an automated, in vitro amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The Test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, 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. Use this collection kit only with the cobas® CT/NG v2.0 Test. 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 the cobas® CT/NG v2.0 Test.

Source page: https://510kreport.com/device/K163184
Methodology: https://510kreport.com/methodology