510(k) · Cleared
Recalled · Class II · 2014Cobas 4800 CT / NG Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Cleared on Jan 24, 2012 as substantially equivalent to K060652 (Gen-Probe, Inc., 2006) and 3 other predicates after a 298-day review. Its family tree reaches back 3 generations to 2001. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 24, 2012
- Review
- 298 days
- Class
- Class I
- Product code
- MKZ
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 3 generations to K003395 (2001). 10 ancestors in all, the oldest P950039 (1996). 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003395 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2001 · Recalled
- 2 generations backK081825 BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · Recalled
- 1 generation backK091724 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009
- This deviceK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK173887 cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK202408 cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK260917 cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG…Roche Molecular Systems, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013 · cites it directly9descendants
- K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017 · cites it directly7descendants
- K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018 · 2 generations on6descendants
- K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2021 · 3 generations on3descendants
- K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…Roche Molecular Systems, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003395 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2001 | 1 |
| −2 | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | 1 |
| −1 | K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2009 | — |
| 0 (this device) | K110923 | Cobas 4800 CT / NG Test | Roche Molecular Systems, Inc. | 2012 | — |
| +1 | K132270 | Cobas CT/NG V2.0 Test | Roche Molecular Systems, Inc. | 2013 | — |
| +1 | K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017 | — |
| +2 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018 | — |
| +3 | K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021 | — |
| +4 | K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use… | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 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 MKZ? 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 MKZ device
- #1 K230451 Aptima® Chlamydia trachomatis Assayscore 6.4 · 1 generation · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K060652 | Tigris DTS Gen-Probe Aptima Combo 2 AssaySummary page 1…001 (Real Time Nucleic Acid Amplification System) Panel: Microbiology Predicate Devices - Assay: Gen-Probe APTIMA Combo 2 Assay (K060652) BD ProbeTec Q' Chlaniydia trachomatis Amplified DNA Assay (K091724)… | 2006 |
| * | K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssaySummary page 1…Predicate Devices - Assay: Gen-Probe APTIMA Combo 2 Assay (K060652) BD ProbeTec Q' Chlaniydia trachomatis Amplified DNA Assay (K091724) and 80 ProbeTec QXNeisseria gonorrhoeae Amplified DNA Assay'… | 2009 |
| * | K091730 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssaySummary page 1…homatis Amplified DNA Assay (K091724) and 80 ProbeTec QXNeisseria gonorrhoeae Amplified DNA Assay' (K091730) Predicate Device - Collection Abbott multi-Collect Specimen Collection Kit (K092704) Kits 510(k) Premarket Notificati… | 2009 |
| * | K092704 | Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…Summary page 1…Neisseria gonorrhoeae Amplified DNA Assay' (K091730) Predicate Device - Collection Abbott multi-Collect Specimen Collection Kit (K092704) Kits 510(k) Premarket Notification 510(k) Summar y Report… | 2010 |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2014 | Class II | Z-1111-2014 | Device Design | Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media kits. |
| Mar 1, 2013 | Class II | Z-1028-2013 | Process control | Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K132270 (Roche Molecular Systems, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K060652.
How does its category compare?
All MKZ devicesMKZ Dna Probe, Nucleic Acid Amplification, Chlamydia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MKZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MKZ
Too few MKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MKZ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKZ
1in 2025
MAUDE reports naming product code MKZ, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cobas® CT/NG Test is an in vitro nucleic acid amplification test that utilizes Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA to aid in the diagnosis of chlamydial and gonococcal disease. The test may be used with vaginal swab specimens self-collected in a clinical setting and male urine from both symptomatic and asymptomatic individuals.…
Read the full statement (197 words)
The cobas® CT/NG Test is an in vitro nucleic acid amplification test that utilizes Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA to aid in the diagnosis of chlamydial and gonococcal disease. The test may be used with vaginal swab specimens self-collected in a clinical setting and male urine from both symptomatic and asymptomatic individuals. Specimens to be tested should be collected in cobas® PCR Media.
The cobas® PCR Female Swab Sample Kit is used to collect and transport self-collected vaginal swab specimens in a clinical setting. 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 Test. NOTE: This collection kit should not be used for collection of alternative gynecological specimens.
The cobas® PCR Urine Sample Kit is used to collect and transport male 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 Test. NOTE: This collection kit should not be used for collection of female urine specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110923: Cobas 4800 CT / NG Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110923
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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