510(k) · Cleared
ClearedAptima Neisseria gonorrhoeae Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · LSL Dna-Reagents, Neisseria
Cleared on Jan 26, 2024 as substantially equivalent to K063664 (Gen-Probe, Inc., 2007) after a 263-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Jan 26, 2024
- Review
- 263 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063664 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK063664 Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091Gen-Probe, Inc. · 2007
- This deviceK231329 Aptima Neisseria gonorrhoeae AssayHologic, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091 | Gen-Probe, Inc. | 2007 | — |
| 0 (this device) | K231329 | Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. | 2024 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091Summary page 5…ts Classification Name: DNA-Reagents, Neisseria Regulation Number: 866.3390 Regulatory Class: Class II Product Code: LSL Legally Marketed Predicate Devices Predicate #: K063664 Predicate Trade Name: Aptima Neisseria gonorrhoeae Assay Product Code: LSL Device Description Summary Clearance of this pre-mark… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All LSL devicesLSL Dna-Reagents, Neisseria: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Aptima Neisseria gonorrhoeae (GC) Assay is an in vitro qualitative nucleic acid amplification (NAAT) test for the detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the Panther System. The assay may be used to test male urine specimens from symptomatic and asymptomatic individuals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231329: Aptima Neisseria gonorrhoeae Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231329
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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