510(k) · Cleared
Clearedcobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on May 22, 2019 as substantially equivalent to DEN180047 (Hologic, Inc., 2019) after an 89-day review. Its family tree reaches back 1 generation to 2019. 3 later devices descend from it.
- Decided
- May 22, 2019
- Review
- 89 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180047 (2019). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN180047 Aptima Mycoplasma genitalium AssayHologic, Inc. · 2019
- This deviceK190433 cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive…Roche Molecular Systems, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK260917 cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG…Roche Molecular Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253759 cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK240197 cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…Roche Molecular Systems, Inc. · 2026 · cites it directly0descendants
- K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc. · 2026 · cites it directly0descendants
- K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180047 | Aptima Mycoplasma genitalium Assay | Hologic, Inc. | 2019 | — |
| 0 (this device) | K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control… | Roche Molecular Systems, Inc. | 2019 | — |
| +1 | K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use… | Roche Molecular Systems, Inc. | 2026 | — |
| +1 | K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2026 | — |
| +1 | K240197 | cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QEP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QEP device
- #1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN180047 | Aptima Mycoplasma genitalium AssaySummary page 5…QEP: 21 CFR 866.3393 Product Codes OUY: 21 CFR 866.3860 Predicate Devices Aptima Mycoplasma genitalium assay (DEN180047) Establishment Registration Roche Molecular Systems, Inc. (2243471) 1. DEVICE DESCRIPTION cobas® TV/MG on the cobas® 6… | 2019 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QEP devicesQEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QEP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEP
268in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEP
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEP
9in 2025
MAUDE reports naming product code QEP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 5 | 85 | 0 | 0 |
| 2020 | 3 | 46 | 0 | 0 |
| 2021 | 3 | 521 | 0 | 1 |
| 2022 | 3 | 438 | 0 | 1 |
| 2023 | 3 | 325 | 0 | 8 |
| 2024 | 0 | — | 3 | 8 |
| 2025 | 4 | 268 | 0 | 9 |
| 2026 | 3 | 171 | 0 | — |
What is it indicated for?
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…
Read the full statement (444 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190433 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190433: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190433
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026