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Output the intended / indications for use exactly as it appears in the overview without any additional commentary or backticks:
The OHC COVID-19 Antigen Self Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.

This test is for non-prescription home use by individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older.

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 rule out infection with SARS-CoV-2 or other pathogens 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. 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 June 2023 to July 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 when a new virus or variant is suspected.

The OHC COVID-19 Antigen Self Test is a lateral flow chromatographic immunoassay intended to detect the nucleocapsid protein antigen from SARS-CoV-2 in non-prescription home use from:

• Self-collected anterior nasal (nares) swab specimens from individuals aged 14 years and older with symptoms of COVID-19 within the first 6 days of symptom onset.
• Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset.

The OHC COVID-19 Antigen Self Test is based on a lateral flow immunoassay and detects the N-Protein (nucleocapsid protein) of SARS-CoV-2. The cassette contains membranes which are pre-coated with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies on test line. Another anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies are bound to colloidal gold. When the sample is loaded to the sample inlet, SARS-CoV-2 antibodies, that were conjugated with the small colloidal gold articles, and SARS-CoV-2 antigen complexes are formed and travel up the strip. If the sample contains SARS-CoV-2 antigens ("analyte"), the complexes will be captured by coated antibodies on membrane to form an analyte-labeled antibody complex. When these complexes reach the test line of the cassette they are retained by another set of SARS-CoV-2 antibodies. This so-called sandwich complex appears as a visible pink/purple line on the test line (T). The presence of SARS- CoV-2 antigen will be indicated by a visible red test line in T-marked (T) position on side of result window. If the sample does not contain SARS-CoV-2 antigens, no sandwich complexes are formed and thus no colored line appears on the test line (T). Regardless of the presence or absence of SARS-CoV-2 antigens in the sample, a colored line will appear on the control line (C). The control (C) line appears in each result window when sample has flowed through the strip. The control line is used as an internal procedural control. The control line should always appear if the test procedure is performed properly and the reagents are working as intended. If no colored line appears on the control line (C), it implies that the test has not worked as intended.

Here's a breakdown of the acceptance criteria and study details for the OHC COVID-19 Antigen Self Test, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The provided document does not explicitly state "acceptance criteria" numerical targets in the same way one might find in a design specification. Instead, it describes the results of the performance studies which the FDA presumably found acceptable for clearance. The "performance characteristics for SARS-CoV-2 were established" and the device demonstrates "substantial equivalence" to the predicate. For the purpose of this response, the PPA and NPA values from the clinical study are considered the primary performance metrics for acceptance.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Study Details

The provided document describes both analytical and clinical studies.

1. Sample size used for the test set and the data provenance:

   • Clinical Study Test Set: 709 evaluable subjects.
   • Data Provenance: Prospective clinical study conducted at four (4) sites in the United States. Samples were collected by lay users (self-collected or adult-collected for household members). Data was collected from June 2023 to July 2023 when SARS-CoV-2 Omicron was dominant.
   • Analytical Sensitivity (LoD) Study:
     • Preliminary LoD: 5 replicates per dilution, tested on 3 lots.
     • Confirmatory LoD: 20 replicates for the confirmed LoD concentration (and other concentrations), for each of 3 kit lots.
   • Inclusivity Study: 5 replicates per dilution for each of 9 SARS-CoV-2 strains/isolates.
   • Wet Testing JN.1: 5 replicates per dilution.
   • Cross Reactivity/Microbial Interference Study: 3 replicates for each organism/virus in the absence and presence of SARS-CoV-2.
   • Interfering Substances Study: 3 replicates for each substance in the presence and absence of SARS-CoV-2.
   • Hook Effect Study: 5 swabs tested.
   • Precision Study (Study 1): 60 replicates per lot (3 lots), for 3 sample types (negative, 1xLoD, 4xLoD), across 2 operators (360 total tests per operator, per sample type).
   • Precision Study (Study 2): 72 total tests per sample level (0.75xLoD, 4xLoD, negative). This was 3 lots x 2 operators x 3 days x 2 runs x 2 replicates.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document implies the ground truth for the clinical study was established by a "highly sensitivity molecular FDA 510(k) cleared SARS-CoV-2 assay." This suggests a lab-based molecular test (likely PCR) was used, which is generally performed and interpreted by trained laboratory professionals. The specific number and qualifications of experts interpreting these molecular tests or acting as adjudicators for the overall study are not detailed in the provided text.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document does not explicitly describe an adjudication method for the clinical test set. The comparison is made directly against the "highly sensitivity molecular FDA 510(k) cleared SARS-CoV-2 assay."

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This device is a "visually read lateral flow immunoassay device" for "non-prescription home use by individuals aged 14 years and older testing themselves, or adults testing individuals aged 2 years or older." It does not incorporate AI or involve human readers in the traditional sense of medical image interpretation. The "readers" mentioned in the precision studies refer to individuals interpreting the test strip results, not specialists like radiologists or pathologists.

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

   • Yes, in the sense that the device itself is a standalone test. The performance metrics (PPA, NPA) directly represent the OHC COVID-19 Antigen Self Test's ability to detect SARS-CoV-2 antigens based on visual interpretation of the test strip, without any human-in-the-loop involvement beyond following the instructions for use and reading the result. There is no "algorithm" separate from the biochemical reaction that produces a visual line.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical evaluation, the primary ground truth was a "highly sensitivity molecular FDA 510(k) cleared SARS-CoV-2 assay" (likely PCR), which is a widely accepted laboratory standard for SARS-CoV-2 detection.
   • For analytical studies (LoD, inclusivity, cross-reactivity, hook effect), the ground truth was established using known concentrations of heat-inactivated SARS-CoV-2 virus or other microorganisms/substances.

7. The sample size for the training set:

   • The provided document describes performance studies (analytical and clinical) for the device. It does not mention a training set in the context of machine learning or AI models, as this is a lateral flow immunoassay, not an AI-powered diagnostic. The mentioned studies are primarily verification and validation studies to demonstrate the device's performance characteristics.

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

   • As no training set for an AI/ML model is described, this question is not applicable. The device's design and manufacturing processes are validated through the analytical and clinical studies presented.

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The QuickFinder™ COVID-19Flu Antigen Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein 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 nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 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 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 seek follow-up care from their healthcare provider.

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

QuickFinder™ COVID-19/Flu Antigen Pro Test

The QuickFinder™ COVID-19/Flu Antigen Pro Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein 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 use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 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 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 seek follow-up care from their healthcare provider.

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

The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is a rapid lateral flow test for the qualitative detection of the SARS-CoV-2, Influenza A and Influenza B using anterior nares nasal swab samples from those who are suspected of COVID-19, Influenza A, and Influenza B. The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is validated for testing direct samples without transport media.

The lateral flow test is for:

• . Self-collected anterior nasal (nares) swab specimens from individuals aged 14 years and older with symptoms of COVID-19 within the first 4 days of symptom onset.
• Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years ● and older with symptoms of COVID-19 within the first 4 days of symptom onset.

The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is a lateral flow test. The cassette contains membranes which are pre-coated with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies on the test lines. Another anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies are each bound to the beads. When the sample is put into the sample well, the antibodies bound to the beads and the antigen in the sample bind to form complexes and migrate to the membrane. The complexes will be captured by coated antibodies on the membrane, and then the line will form a visible line. The presence of SARS-CoV-2, influenza A and influenza B antigens are indicated by lines visible in the Smarked position, A-marked position, and B-marked position in the results window, respectively. If no colored line appears on the control line (C), it implies that the test has not worked as intended.

Here's a detailed description of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test

The acceptance criteria for the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test are primarily demonstrated through its clinical performance, comparing its results against a highly sensitive, FDA 510(k) cleared molecular assay. Additional analytical performance studies confirm the device's technical capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

Clinical Performance Acceptance Criteria (Implicit from reported results):
While explicit acceptance criteria are not stated as numerical cutoffs in the document, these are the reported performance values that demonstrate the device's efficacy. From context, the reported PPAs and NPAs are likely what the FDA evaluated for establishing substantial equivalence.

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

Test Set (Clinical Evaluation):

• Sample Size: A total of 788 evaluable subjects were enrolled.
• Data Provenance: The clinical study was conducted at six (6) sites in the United States from October 2023 to June 2024. The study was prospective, with samples collected by lay users from themselves or for a household member. Subjects were symptomatic individuals experiencing symptoms associated with COVID-19 or Influenza, within 4 days of symptom onset.

Test Set (Usability/Human Factors Assessment):

• Sample Size: 50 subjects participated (25 self-collecting and 25 lay-users collecting from another).
• Data Provenance: Conducted as part of the clinical study from October 2023 to November 2023, likely in the United States. Prospective, as subjects performed tasks in a simulated home environment.

Test Set (Lay User Readability Assessment):

• Sample Size: All 50 subjects who participated in the human factors assessment also interpreted mock devices.
• Data Provenance: Same as the Usability Assessment.

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

The ground truth for the clinical test set was established by a highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay and highly sensitive molecular FDA 510(k) cleared Influenza A and B assays. The document does not specify the number of experts or their qualifications within the context of establishing this ground truth (e.g., for interpreting the molecular assay results). The molecular assays themselves serve as the expert-level reference standard, implying specialized laboratory personnel and validated methods.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for conflicting results between the QuickFinder™ test and the reference molecular assays. The performance metrics (PPA, NPA) are calculated directly from the comparison. For the usability study, "study personnel or a healthcare provider" evaluated the subjects' performance, implying assessment by trained individuals, but a formal adjudication process (like 2+1) isn't detailed for disagreements, as it focuses on task performance rather than a diagnostic outcome.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance. This device is a lateral flow immunochromatographic assay, a rapid visual test, and does not incorporate AI for result interpretation by human readers. The usability and readability studies assess the lay user's ability to interpret the test results, which is a form of human "reading," but not a comparative effectiveness study with AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The QuickFinder™ devices are standalone rapid visual tests that require human interpretation of the lines on the cassette. They are explicitly stated to "require no instrumentation or mobile applications." Therefore, the clinical performance data, while comparing to a molecular assay, represents the "standalone" performance of the test as interpreted by lay users (for the Self Test) or users (for the Pro Test) without an additional algorithm for interpretation.

7. The Type of Ground Truth Used

The primary ground truth used for evaluating the clinical performance of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test was a highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay and highly sensitive molecular FDA 510(k) cleared Influenza A and B assays. This is considered the gold standard for detecting the presence of viral RNA/antigens.

For the analytical studies (LoD, Co-spiked LoD, Inclusivity, Interference, Hook Effect), the ground truth was established using known concentrations of specific viral strains (UV inactivated SARS-CoV-2 and live Influenza A and B) spiked into pooled human negative swab matrix (PNSM).

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. As this device is a rapid antigen test (lateral flow immunoassay) and likely relies on pre-calibrated reagents and visual signal detection rather than a machine-learning algorithm that requires a "training set" in the computational sense, such information would not typically be applicable or relevant in the same way it would be for AI/ML-based devices. The development of such assays involves extensive analytical validation using contrived and clinical samples, but these are generally referred to as validation sets rather than machine learning "training sets."

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and its associated ground truth establishment methods (e.g., expert consensus, pathology labels, outcome data) are generally not applicable to a lateral flow immunoassay in the same way they would be for an AI/ML device. The analytical performance studies (LoD, inclusivity, interference) use precisely characterized viral material and reference standards to establish the "truth" for those controlled experiments. For the clinical validation, the ground truth was the results from the FDA-cleared molecular assays.

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