510(k) · Cleared
ClearedGen-Probe Aptima Assay for Neisseria Gonorrhoeae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gen-Probe, Inc. · LSL Dna-Reagents, Neisseria
Cleared on Mar 14, 2005 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Mar 14, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK043144 Gen-Probe Aptima Assay for Neisseria GonorrhoeaeGen-Probe, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK121710 Xpert CT/NGCepheid · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK151565 Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems…Cepheid · 2015
- Descendant · 2 generations on · 2 of its ownK200748 Visby Medical Sexual HealthVisby Medical · 2021
- Descendant · 3 generations on · 1 of its ownK220407 Visby Medical Sexual Health TestVisby Medical · 2023
- Descendant · 2 generations on · 1 of its ownK173840 Xpert CT/NGCepheid · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K121710Xpert CT/NGCepheid · 2012 · cites it directly7descendants
- K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid · 2015 · 2 generations on4descendants
- K200748Visby Medical Sexual HealthVisby Medical · 2021 · 2 generations on2descendants
- K220407Visby Medical Sexual Health TestVisby Medical · 2023 · 3 generations on1descendant
- K173840Xpert CT/NGCepheid · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043144 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae | Gen-Probe, Inc. | 2005 | — |
| +1 | K121710 | Xpert CT/NG | Cepheid | 2012 | 3 |
| +2 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx… | Cepheid | 2015 | — |
| +2 | K200748 | Visby Medical Sexual Health | Visby Medical | 2021 | — |
| +3 | K220407 | Visby Medical Sexual Health Test | Visby Medical | 2023 | — |
| +2 | K173840 | Xpert CT/NG | Cepheid | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121710 | Xpert CT/NG | 2012 | 7 |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80… | 2019 | 0 |
| K090971 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | 2009 | 0 |
| K080739 | Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection Kit | 2008 | 0 |
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?
- Of its descendants, K121710 (Cepheid, 2012) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K043144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043144: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043144
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026