510(k) · Cleared
ClearedGen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091
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 Nov 7, 2006 after a 78-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Nov 7, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK062440 Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091Gen-Probe, Inc. · 2006
- 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 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K062440 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091 | Gen-Probe, Inc. | 2006 | — |
| +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 | 3 | 0 |
| 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 6.7 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | GEN-PROBE® APTIMA® Assay for Neisseria gonorrhoeae Named without a submission number |
What descends from it? (16)
See all 163 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091724 (Becton, Dickinson & CO, 2009) has gone furthest, with 13 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 | — |
What is it indicated for?
The APTIMA® Assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male…
Read the full statement (159 words)
The APTIMA® Assay for Neisseria gonorrhoeae is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease. The assay may be used to test the following specimens from symptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens; and female and male urine specimens. The assay may be used to test the following specimens from asymptomatic individuals: clinician-collected endocervical and vaginal swab specimens; and patient-collected vaginal swab specimens and female and male urine specimens. The assay is also intended for use with the testing of gynecological specimens, from both symptomatic and asymptomatic patients, collected in the PreservCyt Solution and processed with the Cytyc ThinPrep 2000 System.
'Patient-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated. The vaginal swab specimen collection kit is not for home use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062440: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062440
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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