(200 days)
The Flowflex Plus COVID-19 Home Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID 19 within the first 6 days of symptom onset.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
The Flowflex Plus COVID-19 Home Test does not differentiate between SARS-CoV and SARS-CoV-2.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as 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. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established during June 2022 to April 2023 when COVID-19 variant Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
The Flowflex Plus COVID-19 Home Test is a visually read lateral flow immunoassay device.
The provided document is an FDA 510(k) clearance letter for the Flowflex Plus COVID-19 Home Test. This document does not contain the acceptance criteria or a detailed study report that proves the device meets the acceptance criteria.
The 510(k) clearance letter acknowledges the device's substantial equivalence to a predicate device based on the information submitted by the manufacturer. It states the indications for use and lists general regulatory provisions. However, it does not provide the specific performance data, such as sensitivity, specificity, or positive/negative predictive values, that were generated during the device's validation studies, nor the pre-defined acceptance criteria for those metrics.
Therefore, I cannot provide the requested information from the given text. A typical 510(k) summary or premarket submission would contain the detailed study results and acceptance criteria. This document is merely the FDA's clearance letter.
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