De Novo · Granted
GrantedCue COVID-19 Molecular Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cue Health, Inc. · QWB Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Granted on Jun 6, 2023 as a new device type through De Novo after a 400-day review. 3 later devices descend from it.
- Decided
- Jun 6, 2023
- Review
- 400 days
- Class
- Class II
- Product code
- QWB
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN220028 Cue COVID-19 Molecular TestCue Health, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253453 Metrix COVID Test; Metrix COVID Test ProAptitude Medical Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253971 Visby Medical Flu and COVID-19 TestVisby Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK232643 Cue COVID-19 Molecular TestCue Health, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K253453Metrix COVID Test; Metrix COVID Test ProAptitude Medical Systems, Inc. · 2026 · cites it directly0descendants
- K253971Visby Medical Flu and COVID-19 TestVisby Medical, Inc. · 2026 · cites it directly0descendants
- K232643Cue COVID-19 Molecular TestCue Health, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023 | — |
| +1 | K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | 2026 | — |
| +1 | K253971 | Visby Medical Flu and COVID-19 Test | Visby Medical, Inc. | 2026 | — |
| +1 | K232643 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 QWB? 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 QWB device
- #1 K253453 Metrix COVID Test; Metrix COVID Test Proscore 11.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
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?
- Of its descendants, K253453 (Aptitude Medical Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QWB devicesQWB Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWB
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QWB
Too few QWB 510(k)s in any year since 2007 to give a median.
Recalls per year · QWB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QWB
1in 2024
MAUDE reports naming product code QWB, 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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Monitoring System (Cue Cartridge Reader) for the rapid, qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic). A negative test result is presumptive, and it is recommended these results be confirmed by a lab-based molecular SARS-CoV-2 assay if…
Read the full statement (147 words)
The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Monitoring System (Cue Cartridge Reader) for the rapid, qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic).
A negative test result is presumptive, and it is recommended these results be confirmed by a lab-based molecular SARS-CoV-2 assay if necessary for patient management. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision.
This test is intended to be sold over-the-counter (OTC) for testing of individuals 18 years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220028 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220028: Cue COVID-19 Molecular Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220028
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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