510(k) · Cleared
Recalled · Class II · 2013BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · LSL Dna-Reagents, Neisseria
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. It has been recalled once.
- Decided
- Nov 13, 2009
- Review
- 155 days
- Class
- Class II
- Product code
- LSL
- Recalls
- 1
- 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 deviceK091730 BD Probetec Neisseria Gonorrhoeae (GC) QX 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) | K091730 | BD Probetec Neisseria Gonorrhoeae (GC) QX 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 LSL? 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 LSL device
- #1 K231329 Aptima Neisseria gonorrhoeae Assayscore 6.8 · 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…3390 Product Code LSL Predicate Devices BD ProbeTec TmNeisseria gonorrhoeae(GC) QX Amplified DNA Assay (K08 1825), Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) (K062440… | 2008 |
| * | K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091Summary page 1…DNA Assay (K08 1825), Gen-Probe APTIMA Assay for Neisseria gonorrhoeae (AGC) (K062440) Device Description The BD ProbeTec CC 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2013 | Class II | Z-1215-2013 | Environmental control | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. |
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 LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LSL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LSL
90in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LSL
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LSL
41in 2025
MAUDE reports naming product code LSL, 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 | 1 | — | 0 | 0 |
| 2009 | 3 | 62 | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 3 | 86 | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 1 | 10 |
| 2018 | 3 | 90 | 0 | 7 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 1 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BD ProbeTecTM Neisseria gonorrhoeae (GC) QX Amplified DNA Assay, when tested with the BD Viper TM System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae 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 (113 words)
The BD ProbeTecTM Neisseria gonorrhoeae (GC) QX Amplified DNA Assay, when tested with the BD Viper TM System in Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of Neisseria gonorrhoeae 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 thamt 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 gonococcal urogenital disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091730 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091730: BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091730
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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