# K253759: cobas liat CT/NG/MG nucleic acid test

- Pathway: 510(k) (Dual Track)
- Applicant: Roche Molecular Systems, Inc.
- Decided: May 15, 2026 after 171 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: 8 generations back to K003395 (2001). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202408: cobas CTNG for use on cobas 6800/8800 systems, Roche Molecular Systems, Inc. (2021) Summary page 6.
- K190433: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit, Roche Molecular Systems, Inc. (2019) Summary page 6.

## Indications for use
The cobas liat CT/NG/MG nucleic acid test 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), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) nucleic acid in male/female urine and vaginal swabs, all in cobas PCR Media (Roche Molecular Systems, Inc.). A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to a higher sensitivity when compared to urine. If female urine is used and MG testing is negative, further testing with a vaginal swab may be indicated if M. genitalium is suspected. This test is intended as an aid in the diagnosis of urogenital infections in both symptomatic and asymptomatic individuals.

Source page: https://510kreport.com/device/K253759
Methodology: https://510kreport.com/methodology