510(k) · Cleared
ClearedCobas Amplicor CT/NG Test for Neisseria Gonorrhoeae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LSL Dna-Reagents, Neisseria
Cleared on Aug 10, 2006 as substantially equivalent to K974342 (Roche Molecular Systems, Inc., 1999) after a 258-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Aug 10, 2006
- Review
- 258 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974342 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK974342 Roche Cobas Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Molecular Systems, Inc. · 1999
- This deviceK053289 Cobas Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Diagnostics Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974342 | Roche Cobas Amplicor CT/NG Test for Neisseria Gonorrhoeae | Roche Molecular Systems, Inc. | 1999 | — |
| 0 (this device) | K053289 | Cobas Amplicor CT/NG Test for Neisseria Gonorrhoeae | Roche Diagnostics Corp. | 2006 | — |
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 LSL? 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 LSL device
- #1 K231329 Aptima Neisseria gonorrhoeae Assayscore 6.7 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K974342 | Roche Cobas Amplicor CT/NG Test for Neisseria GonorrhoeaeSummary page 2…for Neisseria gonorrhoeae Predicate We claim equivalence to the currently marketed COBAS AMPLICOR Device CTING test for Neisseriagonorrhoeaecleared under K974342. Comparison - The table below shows the similarities between the COBAS AMPLICOR sinilarities CT/NG test for Neisseriagonorr… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LSL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSL
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSL
41in 2025
MAUDE reports naming product code LSL, 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 | 1 | — | 0 | 0 |
| 2009 | 3 | 62 | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 3 | 86 | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 1 | 10 |
| 2018 | 3 | 90 | 0 | 7 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Roche Scripts for COBAS AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 Workstation to process swab samples or control material for analysis using either of the following 510(k)-cleared assay test systems:
COBAS AMPLICOR™ CT/NG test for Chlamydia trachomatis
COBAS AMPLICOR™ CT/NG test for Neisseria gonorrhoeae
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053289: Cobas Amplicor CT/NG Test for Neisseria Gonorrhoeae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053289
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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