510(k) · Cleared
ClearedRoche Cobas Amplicor Chlamydia Trachomatis 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 Jun 13, 1997 as substantially equivalent to K922906 (Roche Molecular Systems, Inc., 1993) after a 217-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 13, 1997
- Review
- 217 days
- Class
- Class I
- Product code
- MKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922906 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- This deviceK964507 Roche Cobas Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| 0 (this device) | K964507 | Roche Cobas Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1997 | — |
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? (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 |
|---|---|---|---|
| * | K922906 | Amplicor Chlamydia Trachomatis TestSummary page 1…the Roche AMPLICOR Chlamydia trachomatis Microwell Plate Test performed using the Perkin Elmer 9600 thermal cycler and a conventional photometric microwell plate reader (K922906/C). The AMPLICOR™ Chlamydia trachomatis Test was previously shown to be substantially equivalent to tissue culture with immunoflu… | 1993 |
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.
- 1 other device also cites its predicate K922906.
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™ Chlamydia trachomatis Test is a qualitative in vitro diagnostic test for the detection of Chlamydia trachomatis in clinical specimens on the COBAS AMPLICOR analyzer. The test utilizes the Polymerase Chain Reaction (PCR) nucleic acid amplification technique and nucleic acid hybridization for the detection of Chlamydia trachomatis plasmid DNA in endocervical, male urethral, and male urine samples.
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/K964507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964507: Roche Cobas Amplicor Chlamydia Trachomatis Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964507
Report an extraction error
Are you the manufacturer?
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