510(k) · Cleared
Recalled · Class II · 2024BD CTGCTV2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on May 10, 2022 as substantially equivalent to K182692 (Becton, Dickinson and Company, 2019) after a 438-day review. Its family tree reaches back 4 generations to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- May 10, 2022
- Review
- 438 days
- Class
- Class II
- Product code
- QEP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K984631 (1999). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK984631 Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae…Becton Dickinson Microbiology Systems · 1999 · Recalled
- 3 generations backK081824 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- 2 generations backK151589 BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company · 2016 · Recalled
- 1 generation backK182692 BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company · 2019
- This deviceK210585 BD CTGCTV2Becton, Dickinson and Company · 2022
- Descendant · cites it directly · 0 of its ownK243343 BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025
Most influential descendants
Showing 1 of 1 · See all- K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton, · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna… | Becton Dickinson Microbiology Systems | 1999 | 2 |
| −3 | K081824 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| −2 | K151589 | BD Max CT/GC/TV, BD Max Instrument | Becton, Dickinson and Company | 2016 | 2 |
| −1 | K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019 | — |
| 0 (this device) | K210585 | BD CTGCTV2 | Becton, Dickinson and Company | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K182692 | BD MAX CTGCTV2, BD MAX SystemSummary page 5…sing Sexually Transmitted Infections Classification: Class II Panel: Microbiology (83) Product Code(s): QEP MKZ LSL OUY Predicate Device BD CTGCTV2 on BD MAX System (K182692) Intended Use The BD CTGCTV2 assay incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the d… | 2019 |
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 |
|---|---|---|---|
| K243343 | BD CTGCTV2 | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2024 | Class II | Z-0588-2025 | Software design | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K243343 (Bd Integrated Diagnostic Solutions/Becton,, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182692.
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. 2022, 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 (147 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 is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.
The BD CTGCTV2 assay is available for use on the BD MAX System or the BD COR System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210585 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210585: BD CTGCTV2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210585
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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