510(k) · Cleared
ClearedAptima Combo 2 Assay
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 May 3, 2012 as substantially equivalent to K032194 (Gen-Probe, Inc., 2003) after a 350-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- May 3, 2012
- Review
- 350 days
- Class
- Class II
- Product code
- LSL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032194 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK032194 Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid…Gen-Probe, Inc. · 2003
- This deviceK111409 Aptima Combo 2 AssayGen-Probe, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK132251 Aptima Combo 2 Assay (Panther System)Hologic / Gen-Probe Incorporated · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K132251Aptima Combo 2 Assay (Panther System)Hologic / Gen-Probe Incorporated · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032194 | Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test Assays | Gen-Probe, Inc. | 2003 | — |
| 0 (this device) | K111409 | Aptima Combo 2 Assay | Gen-Probe, Inc. | 2012 | — |
| +1 | K132251 | Aptima Combo 2 Assay (Panther System) | Hologic / Gen-Probe Incorporated | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | K032194 | Tigris DTS Automated Analyzer for Automating Amplified Nucleic Acid Test AssaysSummary page 2…ct Code LSL Device Class 2 Regulation number 866.3390 Substantially Equivalent Devices: APTIMA Combo 2 Assay; K032194 This pre-market application is to clear the APTIMA Combo 2 Assay for use on the PANTHER System. The APTIMA Combo 2 Assay was cle… | 2003 |
| † | K060652 | Tigris DTS Gen-Probe Aptima Combo 2 Assay | 2006 |
| † | K061413 | Aptima CT Assay on the Tigris DTS System | 2006 |
| † | K061509 | Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1196 | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132251 | Aptima Combo 2 Assay (Panther System) | 2013 | 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?
- Its one ancestor has no recall.
- Of its descendants, K132251 (Hologic / Gen-Probe Incorporated, 2013) has gone furthest, with 0 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. 2012, 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 PANTHER System is intended to fully automate amplified nucleic acid test (NAT) diagnostic assays currently developed by Gen-Probe Incorporated (San Diego, CA). The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chiamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamrydial…
Read the full statement (146 words)
The PANTHER System is intended to fully automate amplified nucleic acid test (NAT) diagnostic assays currently developed by Gen-Probe Incorporated (San Diego, CA).
The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chiamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamrydial and/or gonococcal urogenital disease using the PANTHER System as specified.
On the PANTHER System, the assay may be used to test the following specimens from symptomatic and asymptomatic individuals: clinician-collected endocervical, vaginal and male urethral swab specimens, clinician-collected gynecological specimens collected in the PreservCyt Solution, and patient-collected vaginal swab specimens.
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/K111409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111409: Aptima Combo 2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111409
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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