# K253453: Metrix COVID Test; Metrix COVID Test Pro

- Pathway: 510(k) (Traditional)
- Applicant: Aptitude Medical Systems, Inc.
- Decided: Aug 7, 2026 after 305 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
Longest line of descent: 1 generation back to DEN220028 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220028: Cue COVID-19 Molecular Test, Cue Health, Inc. (2023) Summary page 6.

## Indications for use
Metrix COVID Test: The Metrix COVID Test is a single-use (disposable) molecular in vitro diagnostic test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA, that is used with the Metrix Reader (Gen 2). This test is intended for use with anterior nasal (AN) swab specimens, self-collected from individuals aged 14 years or older. This test is intended for individuals with signs and symptoms of COVID-19 (i.e., symptomatic). When testing without healthcare provider oversight, a negative test result is presumptive. Presumptive negative results should be confirmed with a lab-based molecular assay when determined to be appropriate by a healthcare provider. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment. Individuals who test negative and experience continued or worsening respiratory symptoms such as fever, cough and/or shortness of breath should seek follow-up care with their healthcare provider. Positive results do not rule out 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. Metrix COVID Test Pro: The Metrix COVID Test Pro is a single-use (disposable) molecular in vitro diagnostic test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA, that is used with the Metrix Reader (Gen 2). This test is intended for use with anterior nasal (AN) swab specimens, self-collected from individuals aged 14 years or older. This test is intended for individuals with signs and symptoms of COVID-19 (i.e., symptomatic). When testing without healthcare provider oversight, a negative test result is presumptive. Presumptive negative results should be confirmed with a lab-based molecular assay when determined to be appropriate by a healthcare provider. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment. Individuals who test negative and experience continued or worsening respiratory symptoms such as fever, cough and/or shortness of breath should seek follow-up care with their healthcare provider. Positive results do not rule out 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.

Source page: https://510kreport.com/device/K253453
Methodology: https://510kreport.com/methodology