(227 days)
The Flowflex COVID-19 Antigen 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 COVID-19 Antigen Home Test does not differentiate between 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 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 from December 2022 to March 2023 when SARS-CoV-2 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 COVID-19 Antigen Home Test is a visually read lateral flow immunoassay device.
The provided text describes the FDA's clearance of the Flowflex COVID-19 Antigen Home Test but does not contain the detailed performance study information required to answer all aspects of your request. Specifically, it lacks a table of acceptance criteria, the full study details, sample sizes for the test set and training set, and details about expert involvement or adjudication methods.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a table format, nor does it provide a direct table of reported device performance metrics like sensitivity and specificity from a clinical study. It only mentions that the performance characteristics were established.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the document.
- Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Not explicitly stated, but clinical studies for antigen tests are typically prospective.
- Period: "established from December 2022 to March 2023 when SARS-CoV-2 Omicron was dominant."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
This is a standalone test (home use, visually read by individuals). Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and not mentioned. The device itself is an at-home diagnostic, not an AI-assisted diagnostic.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Yes, this is essentially a standalone test in the context of being a self-read, visually interpreted immunoassay. There is no AI algorithm involved; the "performance" refers to the test's ability to detect the antigen itself. The document describes it as "a visually read lateral flow immunoassay device."
7. The Type of Ground Truth Used:
The document states the test is for "qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen." Clinical studies for such devices typically use a highly sensitive and specific laboratory-based molecular test (e.g., RT-PCR) as the gold standard (ground truth) for comparison. The phrase "Additional testing with a lab-based molecular test (e.g., PCR) should be considered..." implies PCR is the reference standard.
8. The Sample Size for the Training Set:
This information is not provided in the document. (Note: For a simple lateral flow immunoassay, there may not be a "training set" in the machine learning sense, but rather an optimization/development set).
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document.
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