510(k) · Cleared
ClearedNeuMoDx CT/NG Assay 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neumodx Molecular, Inc. · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on Dec 22, 2023 as substantially equivalent to K190515 (Hologic, Inc., 2019) after a 325-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Dec 22, 2023
- Review
- 325 days
- Class
- Class II
- Product code
- QEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180047 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K190515 | Aptima Combo 2 Assay (Panther System)Summary page 5…QEP Predicate Device Manufacturer Product Name 510(k) No. Hologic, Inc. Aptima Combo 2 Assay k190515 (Panther System) Device Description The NeuMoDx CT/NG Assay 2.0 is an automated in vitro di… | 2019 |
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K190515.
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. 2023, 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 NeuMoDx CT/NG Assay 2.0, as implemented on the NeuMoDx 96 Molecular System and NeuMoDx 288 Molecular System, is an automated, qualitative test for the direct detection and differentiation of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA as an aid in the diagnosis of chlamydial and gonococcal urogenital disease in symptomatic and asymptomatic individuals. The Assay utilizes real-time Polymerase Chain Reaction (PCR) and may be used to test male and female urine, and self-collected vaginal swab specimens (collected in a clinical setting).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230267: NeuMoDx CT/NG Assay 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230267
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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