510(k) · Cleared
ClearedRoche Cobas Amplicor CT/NG Test for Chlamydia Trachomatis
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 Dec 15, 1998 after a 442-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Dec 15, 1998
- Review
- 442 days
- Class
- Class I
- Product code
- MKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973718 Roche Cobas Amplicor CT/NG Test for Chlamydia TrachomatisRoche Molecular Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK053287 Cobas Amplicor CT/NG Test for Chlamydia TrachomatisRoche Diagnostics Corp. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053287Cobas Amplicor CT/NG Test for Chlamydia TrachomatisRoche Diagnostics Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973718 | Roche Cobas Amplicor CT/NG Test for Chlamydia Trachomatis | Roche Molecular Systems, Inc. | 1998 | — |
| +1 | K053287 | Cobas Amplicor CT/NG Test for Chlamydia Trachomatis | Roche Diagnostics Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053287 | Cobas Amplicor CT/NG Test for Chlamydia Trachomatis | 2006 | 0 |
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?
- Of its descendants, K053287 (Roche Diagnostics Corp., 2006) has gone furthest, with 0 descendants of its own.
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.
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 AMPLICOR CT/NG Test for Chlamydia trachomatis is a qualitative in vitro test for the detection of C. trachomatis plasmid DNA in urine from males and females, in endocervical swab specimens, and in male urethral swab specimens as evidence of symptomatic or asymptomatic infection with C. trachomatis. C. trachomatis DNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target using the COBAS AMPLICOR Analyzer.
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/K973718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973718: Roche Cobas Amplicor CT/NG Test for Chlamydia Trachomatis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973718
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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