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The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.

This test is for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens.

Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay.

This FDA 510(k) clearance letter pertains to a lateral flow immunoassay (a type of rapid diagnostic test), not an AI/computer-aided detection (CAD) device. Therefore, many of the requested criteria (like ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set information) are not directly applicable or would be established differently for an in-vitro diagnostic (IVD) device.

However, I can extract the relevant information regarding acceptance criteria and performance as presented for this type of device.

Key takeaway for this document: This is a clearance for a physical diagnostic test (Flowflex Plus COVID-19 + Flu A/B Home Test), not a software or AI-based medical device. Therefore, the concepts of "ground truth for test set," "adjudication methods," "MRMC studies," "standalone algorithm performance," and "training set details" are not applicable in the typical AI/CAD sense. Instead, the "ground truth" for an IVD device like this is typically established by a gold standard laboratory method (e.g., PCR), and the performance metrics are sensitivity and specificity against that gold standard.

Here's the breakdown based on the provided document and the nature of the device:

Device: Flowflex Plus COVID-19 + Flu A/B Home Test (Lateral flow immunoassay)

1. Table of Acceptance Criteria and Reported Device Performance:

The document itself does not contain the specific performance data (sensitivity, specificity) or the exact acceptance criteria that were used for clearance. Instead, it is the clearance letter stating that the device has been reviewed and found substantially equivalent. To find the actual performance data and acceptance criteria, one would typically need to refer to the full 510(k) submission summary or associated clinical study reports, which are not included here.

For a lateral flow immunoassay like this, the acceptance criteria would typically be defined as minimum acceptable sensitivity and specificity values for each analyte (SARS-CoV-2, Flu A, Flu B) compared to a gold standard molecular test (e.g., RT-PCR).

Hypothetical Example Table (based on typical IVD clearance expectations, not from this document):

Study Proving Device Meets Acceptance Criteria:

The document implicitly states that such a study was conducted and reviewed by the FDA, leading to the substantial equivalence determination. This would be a clinical performance study comparing the results of the Flowflex Plus test to a gold standard laboratory test (e.g., RT-PCR).

Details not explicitly in the document, but standard for IVD tests:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in this clearance letter. For a multi-analyte home test, the sample size would likely be in the hundreds to low thousands of patient samples, ensuring sufficient numbers of positive and negative cases for each analyte.
• Data Provenance: Not specified. For home tests, clinical studies typically involve both prospective collection of samples and sometimes the use of banked, de-identified retrospective samples, often from diverse geographical locations to ensure generalizability. It would likely be from symptomatic individuals, mirroring the intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable in the sense of human image readers for AI. For an in-vitro diagnostic test, the "ground truth" is established by a reference laboratory method, almost always a highly sensitive and specific molecular test (e.g., RT-PCR for SARS-CoV-2 and Influenza). The experts involved would be laboratory professionals performing and interpreting these reference tests, following validated protocols.

4. Adjudication Method for the Test Set:

• Not applicable in the sense of imaging adjudication. For IVD tests, if there are discrepancies between the investigational device and the reference method, these are typically investigated by retesting, re-sampling, or sequence analysis, rather than human "adjudication" of a readout in the way one would for an imaging study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, not applicable. MRMC studies are specific to evaluating the impact of AI/CAD on human reader performance, typically in imaging diagnostics. This device is a direct patient-use diagnostic test.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This isn't an algorithm; it's a physical test. The "standalone performance" is simply the test's sensitivity and specificity when read according to its instructions for use, whether by a lay user or healthcare professional.

7. The type of ground truth used:

• Molecular Reference Method (e.g., RT-PCR): This would be the gold standard for confirming the presence or absence of SARS-CoV-2, influenza A, and influenza B in the patient samples.

8. The sample size for the training set:

• Not applicable in the AI sense. For an IVD like this, there isn't a "training set" for an algorithm. The "training" or development of the immunoassay involves chemical and biological optimization, not machine learning on a dataset. The validation happens through analytical and clinical studies.

9. How the ground truth for the training set was established:

• Not applicable for this type of device.

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