De Novo · Granted
GrantedAptima Mycoplasma genitalium Assay
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
Granted on Jan 23, 2019 as a new device type through De Novo after a 145-day review. 12 later devices descend from it.
- Decided
- Jan 23, 2019
- Review
- 145 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
12 later devices descend from it, 4 citing it directly.
- This deviceDEN180047 Aptima Mycoplasma genitalium AssayHologic, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK190515 Aptima Combo 2 Assay (Panther System)Hologic, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK190433 cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive…Roche Molecular Systems, Inc. · 2019
- Descendant · 2 generations on · 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 · 3 generations on · 1 of its ownK200866 Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris)…Hologic, Inc. · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K190515Aptima Combo 2 Assay (Panther System)Hologic, Inc. · 2019 · cites it directly6descendants
- K190433cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas…Roche Molecular Systems, Inc. · 2019 · cites it directly3descendants
- K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test…Hologic, Inc. · 2020 · 2 generations on2descendants
- 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 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180047 | Aptima Mycoplasma genitalium Assay | Hologic, Inc. | 2019 | — |
| +1 | K190515 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2019 | — |
| +1 | K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control… | Roche Molecular Systems, Inc. | 2019 | — |
| +2 | 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 | — |
| +3 | K200866 | Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) | Hologic, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190515 | Aptima Combo 2 Assay (Panther System) | 2019 | 6 |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas… | 2019 | 3 |
| K202977 | Alinity m STI Assay | 2022 | 1 |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80… | 2019 | 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, K190515 (Hologic, Inc., 2019) has gone furthest, with 6 descendants of its own.
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 Mycoplasma genitalium assay is an in vitro nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium on the fully automated Panther system. It is intended for use as an aid in the diagnosis of M. genitalium urogenital infections in male and female patients suspected of M. genitalium infection. The assay may be used to test the following specimens: clinician-collected and…
Read the full statement (163 words)
The Aptima Mycoplasma genitalium assay is an in vitro nucleic acid amplification test (NAAT) for the qualitative detection of ribosomal RNA (rRNA) from Mycoplasma genitalium on the fully automated Panther system. It is intended for use as an aid in the diagnosis of M. genitalium urogenital infections in male and female patients suspected of M. genitalium infection.
The assay may be used to test the following specimens: clinician-collected and self-collected vaginal swabs (in a clinical setting), clinician-collected endocervical swabs, female and male urine, clinician-collected male urethral swabs, and self-collected penile meatal swabs (in a clinical setting).
For females, a vaginal swab is the preferred specimen type due to higher clinical sensitivity for detecting M. genitalium than other specimen types; however, female urine or clinician-collected endocervical swabs may be used as alternative specimens when vaginal swab specimens are not available. If female urine or clinician-collected endocervical swab specimens test negative, testing with a vaginal swab may be indicated, if M. genitalium infection is suspected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180047 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180047: Aptima Mycoplasma genitalium Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180047
Report an extraction error
Are you the manufacturer?
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