# K190433: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: May 22, 2019 after 89 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: 1 generation back to DEN180047 (2019). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180047: Aptima Mycoplasma genitalium Assay, Hologic, Inc. (2019) Summary page 5.

## 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
- K240197: cobas® liat CT/NG/MG nucleic acid test (2025), 0 descendants of its own

## Indications for use
cobas TV/MG 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 Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical specimens, all collected in cobas PCR Media (Roche Molecular Systems, Inc.). cobas TV/MG also detects TV DNA in cervical specimens collected in PreservCyt solution and MG DNA in self-collected meatal swab specimens (collected in a clinical setting) and clinician-collected meatal swab specimens. This test is intended as an aid in the diagnosis of TV and MG infections in individuals suspected to have TV or MG infection. A vaginal swab (self-collected or clinician-collected) is the preferred specimen type for MG testing in females due to higher sensitivity compared to endocervical swabs and urine. For males, urine is the preferred specimen type due to higher sensitivity compared to meatal swabs. If vaginal swab or male urine is not used and MG testing is negative, further testing with the preferred specimen type may be indicated if M. genitalium infection is strongly suspected. 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 for human specimens. 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 for human specimens. 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 » cobas Cdiff for use on the cobas Liat 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. 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 cobas 6800/8800 Systems

Source page: https://510kreport.com/device/K190433
Methodology: https://510kreport.com/methodology