# DEN220028: Cue COVID-19 Molecular Test

- Pathway: De Novo (Direct)
- Applicant: Cue Health, Inc.
- Decided: Jun 6, 2023 after 400 days
- Product code: QWB (Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens)
- Device class: 2
- Regulation: 21 CFR 866.3984
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K253453: Metrix COVID Test; Metrix COVID Test Pro (2026), 0 descendants of its own
- K253971: Visby Medical Flu and COVID-19 Test (2026), 0 descendants of its own
- K232643: Cue COVID-19 Molecular Test (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN220028
Methodology: https://510kreport.com/methodology