510(k) · Cleared
Recalled · Class II · 2013BD Probetec Neisseria Gonorrhoeae (GC) Q 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 Dec 11, 2008 as substantially equivalent to K003395 (Gen-Probe, Inc., 2001) after a 167-day review. Its family tree reaches back 1 generation to 2001. 26 later devices descend from it. It has been recalled once.
- Decided
- Dec 11, 2008
- Review
- 167 days
- Class
- Class II
- Product code
- LSL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003395 (2001). 26 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK003395 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2001 · Recalled
- This deviceK081825 BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008
- Descendant · cites it directly · 13 of its ownK091724 BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009
- Descendant · cites it directly · 13 of its ownK091730 BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 9 of its ownK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
- Descendant · 3 generations on · 7 of its ownK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K091724BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009 · cites it directly13descendants
- K091730BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2009 · cites it directly13descendants
- K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · 2 generations on10descendants
- K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013 · 3 generations on9descendants
- K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003395 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2001 | 1 |
| 0 (this device) | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | — |
| +1 | K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | Becton, Dickinson & CO | 2009 | — |
| +1 | K091730 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | Becton, Dickinson & CO | 2009 | 1 |
| +2 | K110923 | Cobas 4800 CT / NG Test | Roche Molecular Systems, Inc. | 2012 | 2 |
| +3 | K132270 | Cobas CT/NG V2.0 Test | Roche Molecular Systems, Inc. | 2013 | — |
| +3 | K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 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 6.7 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K098463 | BD ProbeTec ET CT/GC Amplified DNA Assay Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K003395 | Gen-Probe Aptima Combo 2 AssaySummary page 1…LSL Predicate Devices BD ProbeTec ET CT/GC Amplified DNA Assay (K98463 1), APTVIA Combo 2 Assay (K003395) Device Description The BD Probelec GC Q' Amplified DNA Assay is based on the simultaneous amplification and detection of targe… | 2001 |
What descends from it? (26)
See all 267 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091724 | BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay | 2009 | 13 |
| K091730 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | 2009 | 13 |
| K151589 | BD Max CT/GC/TV, BD Max Instrument | 2016 | 6 |
| K140447 | BD Viper LT System | 2014 | 0 |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | 2014 | 0 |
| K090971 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | 2009 | 0 |
| K090827 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | 2009 | 0 |
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?
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ProbeTec Neisseria gonorrhoeae (GC) QX Amplified DNA Assay, when tested with the BD ViperTM System in extracted mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Neisseria gonorrhoeaeDNA in clinician-collected female endocervical and male urethral swabs, patient-collected vaginal swab specimens (in a clinical setting), and female and male urine specimens. The assay is indicated for use with asymptomatic and symptomatic female individuals and symptomatic male individuals to aid in the diagnosis of gonococcal urogenital disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081825: BD Probetec Neisseria Gonorrhoeae (GC) 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/K081825
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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