510(k) · Cleared
Clearedcobas CTNG for use on cobas 6800/8800 systems
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 Jan 21, 2021 as substantially equivalent to K173887 (Roche Molecular Systems, Inc., 2018) after a 153-day review. Its family tree reaches back 7 generations to 2001. 3 later devices descend from it.
- Decided
- Jan 21, 2021
- Review
- 153 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003395 (2001). 14 ancestors in all, the oldest P950039 (1996). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK003395 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2001 · Recalled
- 6 generations backK081825 BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · Recalled
- 5 generations backK091724 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009
- 4 generations backK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · Recalled
- 3 generations backK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
- 2 generations backK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
- 1 generation backK173887 cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018
- This deviceK202408 cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2021
- 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 ownK253756 cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc. · 2026
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
- K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003395 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2001 | 1 |
| −6 | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | 1 |
| −5 | K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2009 | — |
| −4 | K110923 | Cobas 4800 CT / NG Test | Roche Molecular Systems, Inc. | 2012 | 2 |
| −3 | K132270 | Cobas CT/NG V2.0 Test | Roche Molecular Systems, Inc. | 2013 | — |
| −2 | K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017 | — |
| −1 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018 | — |
| 0 (this device) | K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021 | — |
| +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 | K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K173887 | cobas CT/NG for use on cobas 6800/8800 systemsSummary page 4…LSL: Sec. 866.3390 OOI: Sec. 862.2570 Predicate Devices cobas® CT/NG for use on the cobas® 6800/8800 systems (K173887) Establishment Registration Roche Molecular Systems, Inc. (2243471)… | 2018 |
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K260917 (Roche Molecular Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K173887.
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. 2021, 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?
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…
Read the full statement (339 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202408: cobas CTNG for use on cobas 6800/8800 systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202408
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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