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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 BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow immunoassay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 15 years or 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 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 November, 2020 to July, 2022, when SARS-CoV-2 Delta and Omicron were 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 BinaxNOW COVID-19 Antigen Self Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens. SARS-COV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card.

To perform the test, a nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into ugh the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for BinaxNOW COVID-19 Antigen Self Test

The document outlines acceptance criteria generally through reported performance metrics for various analytical and clinical studies. Explicit "acceptance criteria" are not given as pass/fail thresholds in the same way that a test specification would be. Instead, the reported performance serves to demonstrate the device's capabilities.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample Sizes and Data Provenance

Test Set (Clinical Studies):

• Total for Clinical Performance: 604 nasal swabs from symptomatic patients within 5 days of symptom onset.
• Study 1 (Original Study): 295 subjects (resulting in 295 evaluable samples).
• Study 2 (Omicron Study): 309 subjects (resulting in 309 evaluable samples).
• Serial Testing Study: 5,600 eligible participants for analysis, out of 7,361 enrolled. 154 tested positive for SARS-CoV-2 infection by RT-PCR.
• Provenance: All subjects were from the United States.
  • Study 1: Prospective, conducted from November 2020 through March 2021 across five investigational sites (when Delta and Omicron were dominant).
  • Study 2 (Omicron Study): Prospective, "all comers, real world," conducted from March 2022 to July 2022 at a high-volume COVID community testing site (when Omicron and its variants were prevalent). Led by Johns Hopkins Medicine in collaboration with the University of Maryland Medical Center and Maryland Department of Health.
  • Serial Testing Study: Prospective, decentralized clinical study conducted between January 2021 and May 2022 as part of the Rapid Acceleration of Diagnostics (RADx) initiative from NIH, with broad geographical representation in the U.S.

Test Set (Usability Studies):

• Lay User Readability Study: 30 users across various age ranges and with and without vision impairments.

3. Number of Experts and Qualifications for Ground Truth

• The document does not explicitly state the number of experts used to establish the ground truth for the test set in the clinical studies.
• The ground truth in the clinical studies was established using FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for the detection of SARS-CoV-2. These are laboratory-based molecular tests, implying the involvement of qualified laboratory personnel (e.g., medical technologists, molecular diagnosticians) experienced in performing and interpreting these assays, but specific qualifications are not detailed. In the serial testing study, the composite comparator method involved "at least two highly sensitive EUA RT-PCRs" and a third if discordant, performed by presumably qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Clinical Studies (Primary Performance): No explicit adjudication method is described for discrepancies between the BinaxNOW test and the comparator RT-PCR. The RT-PCR is considered the gold standard (comparator method).
• Serial Testing Study (Composite Comparator): A form of adjudication was used for the molecular comparator itself: "If results of the first two molecular tests were discordant a third highly sensitive EUA RT-PCR test was performed, and the final test result was based upon the majority rule." This is a 2+1 adjudication method for establishing the RT-PCR ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted to evaluate human readers with and without AI assistance. The BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow immunoassay, interpreted directly by the user, and does not involve AI assistance for result interpretation.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was conducted. As a visually read immunoassay, the device relies on human interpretation. The "lay user readability study" specifically evaluates human interpretation, not an automated algorithm.

7. Type of Ground Truth Used

• Clinical Studies: The primary ground truth for clinical performance was established using FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assays for SARS-CoV-2.
• Analytical Studies (LoD, Reactivity, Specificity): The ground truth was based on defined concentrations of inactivated SARS-CoV-2 virus strains, international standards, or specific microbial/substance concentrations, as prepared by qualified laboratory personnel.

8. Sample Size for the Training Set

• The document describes performance evaluation studies (test sets) for the BinaxNOW device. It does not provide information about a "training set" in the context of machine learning, as this is a traditional in-vitro diagnostic device that relies on chemical reactions and visual interpretation, not an AI/ML-based device.

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

• As there is no mention of an AI/ML training set, this information is not applicable and not provided in the document.

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The CareSuperb™ 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.

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.

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 SARS-CoV-2 infections 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 symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

Performance characteristics for SARS-CoV-2 were established from October 2023 to April 2024 when SARS-CoV-2 Omicron variant 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 CareSuperb™ COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein in anterior nasal samples.

To begin the test, a self-collected anterior nasal swab sample (in individuals between the age of 2 to 14 a swab collected by a parent or quardian), or a heathcare-provider collected anterior nasal swab sample is inserted into the sample port and the extraction reagent in the dropper vial is added to the extraction to occur exposing the viral nucleocapsid antigens The SARS-CoV-2 antigens present in the sample bind with anti-SARS-CoV-2 antibodies dispensed in the conjuqate wick filter. These antigen-antibody complexes migrate to the the plastic cassette and travel across the membrane through capillary action. The complexes are captured at the tegion, causing a colored line to appear on the membrane.

If the sample contains SARS-CoV-2 antigen, a visible line at the test line ("T") and a procedural control line at the control line ("C") will appear in the result window indicating a positive result. If SARS-CoV 2 viral nucleocapsid antigens are not present, or are present at very low levels, only the procedural control line will appear.

Here's a breakdown of the acceptance criteria and the study that proves the device (CareSuperb™ COVID-19 Antigen Home Test) meets them, based on the provided FDA 510(k) summary:

Summary of Acceptance Criteria and Device Performance

The acceptance criteria for this device are primarily centered around its clinical performance (accuracy) and usability for lay users, as well as robust analytical performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (Clinical Performance):

  • Sample Size: A total of 646 symptomatic subjects were evaluated in the clinical study.
  • Data Provenance: Data was collected from 10 clinical sites in the U.S. between October 2023 and April 2024. This was a prospective study, as subjects self-sampled and self-tested in a simulated home setting.

• Analytical Performance Studies: Sample sizes for these studies vary, but are explicitly stated for each (e.g., 540 replicates per lot for precision, 20 replicates for LoD confirmation, 3 replicates for cross-reactivity/interference studies). The document does not specify a country of origin for these lab-based studies, but for a US FDA submission, it implicitly means the studies adhere to US regulatory standards.

3. Number of Experts and Qualifications for Ground Truth

• For the clinical performance study, the ground truth was established by an FDA-cleared molecular assay (RT-PCR). This is a scientific, objective standard, not dependent on human expert interpretation in the same way imaging studies might be.
• For the adjudication of discrepant results in the clinical study, it states: "All discrepant results were investigated by testing using an alternative FDA-cleared molecular assay at the central laboratory." This further reinforces the objective, lab-based ground truth.
• For analytical studies (LoD, cross-reactivity, etc.), ground truth is established by the known concentrations of spiked analytes and the inherent characteristics of the reference materials. These are objective measures rather than expert consensus.

4. Adjudication Method for the Test Set

• For the clinical performance study, the primary ground truth was an FDA-cleared molecular assay.
• Any discrepant results between the CareSuperb™ test and the primary molecular assay were adjudicated by testing with an alternative FDA-cleared molecular assay at a central laboratory. This acts as a robust, independent verification method for discrepancy resolution. There isn't a "2+1" or "3+1" human reader adjudication since the ground truth is objective molecular testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This is because the device is a visually read lateral flow immunoassay for COVID-19 antigen detection. It is a standalone diagnostic test performed by lay users, not an AI-assisted interpretation tool for images or complex data that would involve human readers and their performance improvement.

6. Standalone Performance (Algorithm Only)

• Yes, the primary clinical performance data (PPA and NPA) represents the standalone performance of the device when used by lay users, as it is a visually read test. There is no "algorithm" in the sense of a software-based AI interpreting results; the interpretation is visual by the user. The performance metrics (PPA, NPA) directly reflect the device's accuracy in identifying positive and negative cases compared to the molecular reference standard.

7. Type of Ground Truth Used

• Clinical Performance Ground Truth: The primary ground truth for the clinical study was an FDA-cleared molecular assay (RT-PCR) result. Discrepant results were further confirmed by an alternative FDA-cleared molecular assay. This is considered a highly reliable and objective gold standard for SARS-CoV-2 detection.
• Analytical Performance Ground Truth: For the analytical studies (LoD, precision, cross-reactivity, inclusivity), the ground truth was established by using known concentrations of purified or inactivated SARS-CoV-2 strains/variants/reference materials and other microorganisms/substances, diluted into a negative clinical matrix (nasal swab matrix).

8. Sample Size for the Training Set

• The document primarily describes a diagnostic test kit (lateral flow immunoassay), not an AI/ML-based algorithm that requires a "training set" in the computational sense.
• The closest equivalent to a "training set" for physical test development would involve extensive R&D and optimization studies during the design phase to establish reagent concentrations, membrane properties, and other manufacturing parameters. This type of "training" isn't quantified by a sample size of patient data in the same way an AI model's training set would be. The clinical and analytical studies presented are validation studies to prove the device works as intended, not data used for "training" the device itself.

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

• As noted above, there isn't a "training set" and associated ground truth in the AI/ML context for this type of device. The development and optimization of the physical components (e.g., antibody selection, membrane type, buffer formulation) are based on robust analytical chemistry and immunology principles, often using characterized biological materials (like specific viral concentrations) as internal benchmarks during the R&D process. The performance of these optimized components is then validated in the extensive analytical and clinical studies detailed in the 510(k) submission.

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The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a visually read lateral flow immunoassay test intended for the 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.

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.

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 SARS-CoV-2 infections 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 April, 2023 to February, 2024 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 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a lateral flow immunoassay intended for non-prescription home use qualitative detection of nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first five (5) days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with two lines: a test line (T line) and a control line (C line).

The device is for in vitro diagnostic use only.

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) consists of the following components:

• . Tube Holder (located in kit box)
• Test Cassette ●
• Tube (pre-filled extraction buffer) ●
• Swab ●
• Quick Reference Instructions ●

The provided 510(k) summary for the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) describes the acceptance criteria and a clinical study demonstrating the device's performance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for home-use COVID-19 antigen tests often involve minimum Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a highly sensitive molecular comparator. While the document doesn't explicitly state "acceptance criteria" as a separate section with specific thresholds, the clinical performance results can be interpreted against expected standards for such devices. For the purpose of this response, we'll assume the achieved performance in the clinical study is what the manufacturer and FDA found acceptable for market clearance.

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

• Test Set Sample Size: 1032 evaluable subjects within 5 days of symptom onset (from a total of 1053 enrolled subjects).
• Data Provenance: Prospective clinical study conducted between April 2023 and February 2024 at nine (9) clinical sites. The country of origin is not explicitly stated, but the manufacturer is Guangzhou Wondfo Biotech Co., Ltd. in China, and the study was likely conducted with data collected in alignment with international regulatory standards for medical device submissions.

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

The document states that the ground truth was established using an "FDA-cleared highly sensitive molecular comparator method." This implies that the ground truth was derived from the result of a molecular test, not directly by a panel of human experts reviewing the cases. Therefore, information on the number and qualifications of experts for ground truth establishment for the clinical test set is not applicable in this context, as the comparator method serves as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the test set results. The comparison is made between the Wondfo 2019-nCoV Antigen Test and an "FDA-cleared highly sensitive molecular comparator method." It is implied that the results of the molecular comparator method are taken as the definitive ground truth without further adjudication.

5. 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

This section is not applicable as the Wondfo 2019-nCoV Antigen Test is a visually read lateral flow immunoassay intended for non-prescription home use. It is not an AI-assisted diagnostic device, nor is it designed for interpretation by multiple expert readers in an MRMC study setting. The device is a standalone test read by lay users.

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

Yes, a standalone performance study was conducted. The clinical study described in section 6 and the non-clinical performance studies (sections 5.1-5.5) represent the standalone performance of the test as it would be used by a lay user without "human-in-the-loop" expert interpretation beyond the visual reading of the test lines by the user.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical study was established by an FDA-cleared highly sensitive molecular comparator method (e.g., PCR), which is considered the gold standard for SARS-CoV-2 detection.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a lateral flow immunoassay, a biochemical test, not an AI/ML-based diagnostic. Therefore, the concept of a training set for an algorithm is not applicable. The device's manufacturing and design would have involved internal validation and optimization, but not in the sense of an algorithm training on a dataset.

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

As explained in point 8, the concept of a training set and its ground truth in the AI/ML sense is not applicable to this lateral flow immunoassay device. The device's performance is based on its biochemical reactions and physical design, which are validated through non-clinical and clinical studies.

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The CorDx Tyfast COVID- 19 Ag Rapid 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.

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 CorDx Tyfast COVID- 19 Ag Rapid 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 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 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 September, 2023, to December, 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 CorDx Tyfast COVID-19 Ag Rapid Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another person 2 years of age or older in a nonlaboratory setting.

The CorDx Tyfast COVID-19 Ag Rapid Test is a rapid, immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 from anterior nasal swab specimens. This test does not differentiate between SARS-CoV and SARS-CoV-2. The test kit includes the: test cassette, swab, tube with sample processing solution, tube holder (back of the box) and the Quick Reference Instructions (QRI).

The test strip enclosed in a cassette housing is comprised of the following components: sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains colloidal-gold conjugated with a monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibody for the nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic cassette.

When the sample extract is added into the sample well, conjugates dried onto the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 nucleocapsid antigen is present in the sample, a complex formed between the anti-SARS-2 conjugate and the viral antigen will be captured by the specific anti-SARS-2 monoclonal antibody coated on the test line region (T). Absence of the test line (T) suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.

The CorDx Tyfast COVID-19 Ag Rapid Test is a qualitative lateral flow immunoassay intended for the rapid detection of SARS-CoV-2 virus nucleocapsid protein antigen in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19. It is designed for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device performance are based on the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a highly sensitive 510(k)-cleared SARS-CoV-2 RT-PCR assay.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: 740 individuals were enrolled in the study, with 693 evaluable subjects.
  • True Positives: 101 subjects
  • True Negatives: 572 subjects
  • Discordant Results (Test Negative, Comparator Positive): 17 subjects
  • Discordant Results (Test Positive, Comparator Negative): 3 subjects
• Data Provenance: The clinical study was prospective, conducted from September 2023 to December 2023 at four (4) sites throughout the United States. This indicates the data is prospective and from the USA.
• Training Set Sample Size: The document does not provide specific details on the training set sample size for any machine learning components, as this is a visually read lateral flow immunoassay and not explicitly an AI/ML device in the context of the provided text. The "Precision Study by Lots" used 60 replicates for each of 3 lots (180 total) for negative, 2xLoD, and 4xLoD samples to assess analytical precision and consistency.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years experience) used to establish ground truth. However, the ground truth was established by a "highly sensitive 510(k)-cleared SARS-CoV-2 RT-PCR assay," which is considered the gold standard for SARS-CoV-2 detection. Therefore, the expertise lies in the validated performance of the comparator RT-PCR assay and its operation in a clinical laboratory setting.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for discordant results in the clinical study beyond simply identifying the discordant cases. The final ground truth was determined by the RT-PCR assay, implying that the RT-PCR result was considered definitive for the purpose of performance calculation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted. This device is a visually read rapid antigen test, and the study design focused on the device's performance against a gold standard molecular assay, not on human reader improvement with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Standalone performance (algorithm only) was not explicitly conducted or reported, as this device is a visually read lateral flow immunoassay. Its performance is inherent in its design and the user's interpretation, rather than an independent algorithm.

7. Type of Ground Truth Used

The primary ground truth used for the clinical performance evaluation was a highly sensitive 510(k)-cleared SARS-CoV-2 RT-PCR assay. This is a molecular diagnostic method, considered a definitive reference standard for SARS-CoV-2 infection.

8. Sample Size for the Training Set

As this is a visually read rapid antigen test and not an AI/ML diagnostic system in the conventional sense, a 'training set' for an algorithm is not applicable in the way it would be for an image-based AI system. The analytical performance evaluations would involve internal validation data. For instance, the "Precision Study by Lots" utilized 180 samples in total across three lots for each concentration (negative, 2xLoD, 4xLoD) to demonstrate analytical consistency.

9. How Ground Truth for the Training Set Was Established

Given that this is not an AI/ML device with a distinct 'training set' for an algorithm, the concept of establishing ground truth for a training set in that context is not applicable. For internal analytical studies (like LoD, inclusivity, cross-reactivity, and precision), ground truth was established through:

• Spiking known concentrations of SARS-CoV-2 virus: For LoD and inclusivity studies, UV-inactivated or heat-inactivated SARS-CoV-2 virus (USA-WA1/2020 isolate or specific variants) at defined TCID50/mL or IU/mL concentrations were spiked into negative nasal wash or swab matrix.
• Testing against known common respiratory pathogens/substances: For cross-reactivity and interference studies, known concentrations of various microorganisms or endogenous/exogenous substances were used, both with and without spiked SARS-CoV-2 (at 3x LoD), to assess their impact on test results.
• Use of WHO International Standard: For LoD determination, the WHO International Standard for SARS-CoV-2 Antigen (NIBSC 21/368) was used to ensure traceability.

These methods establish the "ground truth" for the analytical performance characteristics of the device during its development and validation.

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The iHealth COVID-19 Antigen Rapid 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 nonprescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.

The iHealth COVID-19 Antigen Rapid 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 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 from October 2022 to June 2023 when the 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 iHealth COVID-19 Antigen Rapid Test employs lateral flow immunoassay technology. Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV-2.

To begin the test, a self-collected anterior nares swab sample in individuals aged 15 and older or individuals between the age of 2 to 14 with a swab collected by a parent or quardian is inserted into a tube that has been pre-filled with reagent. The reagent in the tube interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The liguid in the tube, now containing the specimen, is added to the Sample Port of the COVID-19 Test Card.

If the extracted specimen contains SARS-CoV-2 antigens, a pink-to-purple T Line, along with a pink-to-purple C Line will appear on the COVID-19 Test Card indicating a positive result. If SARS-CoV-2 antigens are not present at very low levels, only a pinkto-purple C Line will appear.

Acceptance Criteria and Study to Prove Device Meets Criteria: iHealth COVID-19 Antigen Rapid Test

The iHealth COVID-19 Antigen Rapid 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 nonprescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 915 individuals.
• Data Provenance:
  • Country of Origin: United States (investigational sites throughout the U.S.).
  • Retrospective or Prospective: Prospective. The clinical performance characteristics were evaluated in a study where subjects with signs and symptoms of COVID-19 were enrolled, collected samples, and the test was performed. Data was collected between October 2022 to June 2023.

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

The document does not explicitly state the number of "experts" used for ground truth or their specific qualifications for the clinical study.

• Ground Truth Method: The iHealth COVID-19 Antigen Rapid Test results were compared to a highly sensitive molecular FDA EUA Authorized SARS-CoV-2 assays (RT-PCR) to determine test performance. This molecular test is considered the gold standard for SARS-CoV-2 detection, establishing the definitive ground truth for the presence or absence of the virus.

4. Adjudication Method for the Test Set

The document indicates that for discordant results (false positives or false negatives against the initial comparator method), a "second FDA EUA high sensitivity molecular SARS-CoV-2 assay" was used. This suggests a form of 2+1 adjudication where the initial comparator result is one "read," the iHealth test result is the other, and a second molecular assay acts as the tie-breaker or confirmatory truth.

• Specifically:
  • Of 13 false negative samples (iHealth negative, comparator positive), 1 was confirmed negative by a second molecular assay, and 12 were confirmed positive.
  • Of 1 false positive sample (iHealth positive, comparator negative), it was confirmed positive by a second molecular assay.

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

No, an MRMC comparative effectiveness study was not explicitly done in the context of comparing human readers with and without AI assistance, as this is an antigen rapid test that is visually read by lay users. The study evaluated the standalone performance of the test as interpreted by lay users (self-testers or adult testers for children).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

For the clinical performance evaluation, the test was performed by lay users (individuals aged 15+ testing themselves, or adults testing individuals aged 2-14). Therefore, the clinical performance data presented (PPA, NPA) represents the device's performance with human-in-the-loop interpretation by the intended user. It is not a purely "algorithm-only" or "standalone" performance without any human involvement in interpreting the visual result. However, the device itself is a diagnostic test, not an AI/algorithm for image interpretation. The "algorithm" here (lateral flow immunoassay) is inherent to the device's physical mechanism.

Other analytical studies (precision, LoD, cross-reactivity, etc.) represent technical performance without human interpretation error as these are typically performed in a controlled lab setting by trained personnel.

7. The Type of Ground Truth Used

The primary ground truth for the clinical study (testing individuals) was established using a highly sensitive molecular FDA EUA Authorized SARS-CoV-2 assay (RT-PCR). For discordant results, a second molecular assay was used for confirmation.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical device (an antigen rapid test). It does not explicitly mention a "training set" in the context of machine learning. The term "training set" is typically used for AI/ML models. If the underlying assay development involved any statistical modeling or calibration, the data used for that would precede this type of submission. However, for a lateral flow immunoassay, the "training" involves optimizing the biochemical reagents and visual readout.

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

Given that this is a lateral flow immunoassay device and not an AI/ML diagnostic, the concept of a "training set" with established ground truth as commonly understood in AI/ML is not directly applicable. The "ground truth" during the development and optimization phases would involve rigorous analytical validation using known positive and negative samples, purified viral cultures, and clinical samples characterized by gold standard molecular tests (like RT-PCR), similar to the analytical studies detailed (e.g., LoD, inclusivity, cross-reactivity) but performed during product development before clinical trials.

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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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The QuickVue COVID-19 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 (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 5 days from symptom onset. 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.

The QuickVue COVID-19 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 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 January 2021 to February 2024 when COVID-19 variants Alpha, Delta and Omicron were 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 QuickVue COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

To begin the test, a self-collected anterior nasal swab sample (in individuals aged 14 and older or individuals between the age of 2 to 14 a swab collected by a parent or guardian), or a healthcare collected anterior nasal swab sample is inserted into the pre-filled reagent tube. The reagent disrupts the virus particles in the specimen, exposing internal viral nucleocapsid antigens. The test strip is then placed in the reagent tube where the viral nucleocapsid antigens in the specimen will react with the reagents in the test strip.

If the extracted specimen contains SARS-CoV-2 viral nucleocapsid antigens, a pink-to-red test line along with a blue procedural control line will appear on the test strip indicating a positive result. If SARS-CoV-2 viral nucleocapsid antigens are not present, or are present at very low levels, only the blue procedural control line will appear.

This document describes the performance of the QuickVue COVID-19 Test, a visually read lateral flow immunoassay device. The acceptance criteria and supporting study details are outlined below.

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for performance are generally implied by the reported results. For a rapid diagnostic test like this, the key performance metrics are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). While explicit numerical acceptance criteria for PPA and NPA are not stated as "acceptance criteria," the study aimed to demonstrate substantial equivalence to a predicate device, which implies similar or better performance. The performance must also be sufficient for its intended use as an over-the-counter home test.

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

• Test Set Sample Size: A total of 780 symptomatic individuals were included in the prospective clinical study that compared the QuickVue COVID-19 Test performance to an EUA extracted SARS-CoV-2 RT-PCR assay.
  • 200 individuals were positive by the comparator assay.
  • 580 individuals were negative by the comparator assay.
• Data Provenance: The study was a prospective clinical study conducted at eight clinical sites. The country of origin is not explicitly stated, but given the FDA review, it is highly likely to be the United States. Samples were collected by lay users (self-collected) or collected for a household member.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth was established by an EUA extracted SARS-CoV-2 RT-PCR assay, which is considered the gold standard for SARS-CoV-2 detection. Therefore, human expert judgment for result interpretation of the ground truth assay itself is less relevant than with image-based AI studies.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by a laboratory-based RT-PCR assay, not through human reader interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a visually-read lateral flow immunoassay intended for direct diagnosis, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI outputs. The comparison was to a molecular (RT-PCR) test, not a comparative effectiveness study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The QuickVue COVID-19 Test is a visually read lateral flow immunoassay. It does not involve an algorithm for automated interpretation in its primary intended use. While it has an optional "QVue Mobile Application," the primary interpretation is visual by the user. Therefore, a "standalone algorithm performance" study as seen in AI/software medical devices is not directly applicable in the same way. The performance data presented (PPA, NPA) directly reflects the visually-read results.

7. Type of Ground Truth Used

The type of ground truth used was a lab-based molecular test (RT-PCR). Specifically, an "EUA extracted SARS-CoV-2 RT-PCR assay" was used as the comparator. This is widely considered the gold standard for detecting SARS-CoV-2 viruses.

8. Sample Size for the Training Set

The document describes the performance of a lateral flow immunoassay, not an AI/machine learning model that typically requires a large training set. Therefore, there is no "training set" in the context of an AI model. The development of an immunoassay involves analytical studies and in-house testing to optimize the reagent formulations and visual interpretation, but not a distinct "training set" like in deep learning.

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

As there is no "training set" in the context of an AI model, this question is not applicable. The development of the immunoassay itself relies on established laboratory practices, analytical sensitivity (LoD), inclusivity, and specificity studies, using characterized viral isolates and clinical samples, to ensure the test consistently produces accurate results across various conditions.

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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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