510(k) · Cleared
ClearedBD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Cleared on Nov 13, 2009 as substantially equivalent to K081825 (Becton, Dickinson & CO, 2008) and 1 other predicate after a 155-day review. Its family tree reaches back 2 generations to 2001. 13 later devices descend from it.
- Decided
- Nov 13, 2009
- Review
- 155 days
- Class
- Class I
- Product code
- MKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003395 (2001). 3 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK003395 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2001 · Recalled
- 1 generation backK081825 BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · Recalled
- This deviceK091724 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009
- Descendant · cites it directly · 10 of its ownK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 9 of its ownK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK173887 cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK202408 cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · cites it directly10descendants
- K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013 · 2 generations on9descendants
- K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017 · 2 generations on7descendants
- K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2018 · 3 generations on6descendants
- K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003395 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2001 | 1 |
| −1 | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | 1 |
| 0 (this device) | K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2009 | — |
| +1 | K110923 | Cobas 4800 CT / NG Test | Roche Molecular Systems, Inc. | 2012 | 2 |
| +2 | 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 | — |
| +3 | K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018 | — |
| +4 | K202408 | cobas CTNG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 6.3 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssaySummary page 1…0 Product Code LSL Predicate Devices BD ProbeTec TM Neisseria gonorrhoeae(GC) Q0Amplified DNA Assay (K081825), Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) (K0624… | 2008 |
| * | K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091Summary page 1…DNA Assay (K081825), Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) (K062440) Device Description The BD ProbeTec GC Q' Amplified DNA Assay is based on the simultaneous amplification and detection of targe… | 2006 |
What descends from it? (13)
See all 132 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 8 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K110923 (Roche Molecular Systems, Inc., 2012) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K081825.
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. 2009, 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 BD ProbeTecTM Chlamydia trachomatis(CT) QX Amplified DNA Assay, when tested with the BD ViperTM System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is…
Read the full statement (111 words)
The BD ProbeTecTM Chlamydia trachomatis(CT) QX Amplified DNA Assay, when tested with the BD ViperTM System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens (both UPT and Neat). The assay is also intended for use with gynecological specimens collected in BD SurePathTM Preservative Fluid using an aliquot that is removed prior to processing for the BD SurePathTM Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091724: BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091724
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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