510(k) · Cleared
ClearedAptima Combo 2 Assay (Panther System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on May 23, 2019 as substantially equivalent to DEN180047 (Hologic, Inc., 2019) after an 83-day review. Its family tree reaches back 1 generation to 2019. 6 later devices descend from it.
- Decided
- May 23, 2019
- Review
- 83 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180047 (2019). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN180047 Aptima Mycoplasma genitalium AssayHologic, Inc. · 2019
- This deviceK190515 Aptima Combo 2 Assay (Panther System)Hologic, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK200436 Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay…Hologic, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK202977 Alinity m STI AssayAbbott Molecular, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK200866 Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris)…Hologic, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK230267 NeuMoDx CT/NG Assay 2.0Neumodx Molecular, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK222379 Alinity m STI AssayAbbott Molecular, Inc. · 2023 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc. · 2020 · cites it directly2descendants
- K202977Alinity m STI AssayAbbott Molecular, Inc. · 2022 · cites it directly1descendant
- K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)Hologic, Inc. · 2020 · 2 generations on1descendant
- K230267NeuMoDx CT/NG Assay 2.0Neumodx Molecular, Inc. · 2023 · cites it directly0descendants
- K222379Alinity m STI AssayAbbott Molecular, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180047 | Aptima Mycoplasma genitalium Assay | Hologic, Inc. | 2019 | — |
| 0 (this device) | K190515 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2019 | — |
| +1 | K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) -… | Hologic, Inc. | 2020 | — |
| +1 | K202977 | Alinity m STI Assay | Abbott Molecular, Inc. | 2022 | — |
| +2 | K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | Hologic, Inc. | 2020 | — |
| +1 | K230267 | NeuMoDx CT/NG Assay 2.0 | Neumodx Molecular, Inc. | 2023 | — |
| +2 | K222379 | Alinity m STI Assay | Abbott Molecular, Inc. | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 QEP? 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 QEP device
- #1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | DEN180047 | Aptima Mycoplasma genitalium AssaySummary page 3…393 Regulatory Class: Class II Product Code: QEP, LSL, MKZ III. PREDICATE DEVICE The predicate device is the Aptima Mycoplasma genitalium Assay; DEN180047, cleared January 23, 2019. IV. DEVICE DESCRIPTION Clearance of this pre-market application will add extra-genital (throat and r… | 2019 |
What descends from it? (6)
3 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?
How does its category compare?
All QEP devicesQEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QEP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEP
268in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEP
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEP
9in 2025
MAUDE reports naming product code QEP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 5 | 85 | 0 | 0 |
| 2020 | 3 | 46 | 0 | 0 |
| 2021 | 3 | 521 | 0 | 1 |
| 2022 | 3 | 438 | 0 | 1 |
| 2023 | 3 | 325 | 0 | 8 |
| 2024 | 0 | — | 3 | 8 |
| 2025 | 4 | 268 | 0 | 9 |
| 2026 | 3 | 171 | 0 | — |
What is it indicated for?
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 Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified. On the Panther System, the assay may be used to test the following specimens from symptomatic and…
Read the full statement (100 words)
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 Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the
diagnosis of chlamydial and/or gonococcal 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, throat,
rectal and male urethral swab specimens, clinician-collected gynecological specimens
collected in the PreservCyt® Solution, patient-collected vaginal swab specimens, and female
and male urine specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190515: Aptima Combo 2 Assay (Panther System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190515
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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