510(k) · Cleared
ClearedCue 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
Cleared on Nov 28, 2023 as substantially equivalent to DEN220028 (Cue Health, Inc., 2023) after a 90-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Nov 28, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- QWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220028 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220028 Cue COVID-19 Molecular TestCue Health, Inc. · 2023
- This deviceK232643 Cue COVID-19 Molecular TestCue Health, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023 | — |
| 0 (this device) | K232643 | Cue COVID-19 Molecular Test | Cue Health, Inc. | 2023 | — |
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 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
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 |
|---|---|---|---|
| * | DEN220028 | Cue COVID-19 Molecular TestSummary page 5…21 CFR § 866.3984 Classification: Class II (Special Controls) Predicate Device: Cue COVID-19 Molecular Test (DEN220028) Intended Use The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Health Monitorin… | 2023 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN220028.
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 Health 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 (148 words)
The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Health 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/K232643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232643: Cue COVID-19 Molecular Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232643
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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