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 Jun 5, 2009 as substantially equivalent to K081825 (Becton, Dickinson & CO, 2008) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 2001. It has been recalled once.
- Decided
- Jun 5, 2009
- Review
- 60 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. No later device cites it as a predicate yet.
- 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 deviceK090971 BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2009
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) | K090971 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | Becton, Dickinson & CO | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssaySummary page 1…Code LSL Predicate Devices BD ProbeTec TM Neisseriagonorrhoeae (GC) QX Amplified DNA Assay (K081825) Gen-Probe Amplified Neisseria gonorrhoeaeAssay (K043144) Device Description The BD ProbeTec… | 2008 |
| * | K043144 | Gen-Probe Aptima Assay for Neisseria GonorrhoeaeSummary page 1…gonorrhoeae (GC) QX Amplified DNA Assay (K081825) Gen-Probe Amplified Neisseria gonorrhoeaeAssay (K043144) Device Description The BD ProbeTec GC QX Amplified DNA Assay is based on the simultaneous amplification and detection of target… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 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 ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay, when tested with the BD Viper System in extracted mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA 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…
Read the full statement (113 words)
The BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay, when tested with the BD Viper System in extracted mode, uses Strand Displacement Amplification (SDA) technology for the direct, qualitative detection of Neisseria gonorrhoeae DNA 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 and male individuals to aid in the diagnosis of gonococcal urogenital disease.
The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent package insert(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090971: 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 6, 2026. https://510kreport.com/device/K090971
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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