510(k) · Cleared
ClearedBD CTGCTV2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Integrated Diagnostic Solutions/Becton, · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on Apr 22, 2025 as substantially equivalent to K210585 (Becton, Dickinson and Company, 2022) after a 179-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Apr 22, 2025
- Review
- 179 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K984631 (1999). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
- 4 generations backK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- 3 generations backK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
- 2 generations backK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
- 1 generation backK210585 BD CTGCTV2Becton, Dickinson and Company · 2022 · Recalled
- This deviceK243343 BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… | Becton Dickinson Microbiology Systems | 1999 | 2 |
| −4 | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| −3 | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | 2 |
| −2 | K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019 | — |
| −1 | K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022 | 1 |
| 0 (this device) | K243343 | BD CTGCTV2 | Bd Integrated Diagnostic Solutions/Becton, | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 QEP? 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 QEP device
- #1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K210585 | BD CTGCTV2Summary page 6…ginalis Nucleic Acid Amplification Test System OOI - Real time nucleic acid amplification system Predicate Device: Trade Name/Device Name: BD CTGCTV2 510(k) Number: (K210585) Device Establishment: Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Registration Number: 1119779 Performanc… | 2022 |
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 9 ancestors have a recall of any class.
How does its category compare?
All QEP devicesQEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QEP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEP
268in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEP
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEP
9in 2025
MAUDE reports naming product code QEP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 5 | 85 | 0 | 0 |
| 2020 | 3 | 46 | 0 | 0 |
| 2021 | 3 | 521 | 0 | 1 |
| 2022 | 3 | 438 | 0 | 1 |
| 2023 | 3 | 325 | 0 | 8 |
| 2024 | 0 | — | 3 | 8 |
| 2025 | 4 | 268 | 0 | 9 |
| 2026 | 3 | 171 | 0 | — |
What is it indicated for?
The BD CTGCTV2 assay incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from: Chlamydia trachomatis (CT) Neisseria gonorrhoeae (GC) Trichomonas vaginalis (TV) The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting) and male and female urine specimens. The assay may also be used for the…
Read the full statement (178 words)
The BD CTGCTV2 assay incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:
Chlamydia trachomatis (CT)
Neisseria gonorrhoeae (GC)
Trichomonas vaginalis (TV)
The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting) and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in ThinPrep® PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep® Pap test. The assay may also be used for the detection of CT and GC DNA in clinician-collected rectal and oropharyngeal swab specimens.
The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial, gonococcal, and/or trichomoniasis urogenital disease and chlamydial and gonococcal extragenital infection.
The BD CTGCTV2 assay is available for use with the BD MAX™ System (urogenital specimens) or the BD COR™ System (urogenital and extragenital specimens), as described above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243343: BD CTGCTV2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243343
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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