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The Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions.

Positive results do not rule out bacterial infection or co-infection with other viruses.

The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens.

The assay kit consists of 25 test cassette devices, 25 reagent tubes, 25 ampules containing extraction buffer, 25 anterior nasal specimen collection swabs, one positive control swab, one negative control swab, one Instructions for Use, and one Quick Reference Instruction. An external positive control swab contains noninfectious influenza A, influenza B, and SARS-CoV-2 antigens dried onto the swab and an external negative control swab contains noninfectious blank universal viral transport media dried on the swab. The kit should be stored at 2°C - 30°C.

Device Acceptance Criteria and Performance Study: Nano-Check Influenza+COVID-19 Dual Test

The Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay for the qualitative detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens in anterior nasal swab samples. The device's acceptance criteria and performance were established through extensive analytical and clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

The following table summarizes the key acceptance criteria and the performance achieved by the Nano-Check Influenza+COVID-19 Dual Test based on the provided 510(k) summary. Given that this is a qualitative assay, the primary performance metrics are Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) in clinical studies, and various measures of agreement/detection rates in analytical studies.

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

• Clinical Study Test Set Sample Size: A total of 1,969 subjects were enrolled in the clinical study.
• Data Provenance: The data was collected from a multi-center, prospective clinical study in the U.S. between November 2022 and February 2025.

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

The device being reviewed is an in vitro diagnostic (IVD) test for antigen detection. For such devices, the "ground truth" in clinical performance studies is typically established by a highly sensitive and specific molecular assay (RT-PCR), rather than by human experts interpreting images or signals from the test device itself.

• In this case, the ground truth for the clinical test set was established using an FDA-cleared RT-PCR method as the comparator.
• The document does not specify the number of experts directly involved in establishing the RT-PCR ground truth or their qualifications beyond stating it was performed at a "reference laboratory as per the cleared instruction for use." This implies that qualified laboratory personnel, adhering to standardized RT-PCR protocols, established the ground truth.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology reads) where discrepancies between readers need to be resolved. Since the Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunoassay interpreted visually by an operator, and the ground truth was established by an RT-PCR molecular assay, no explicit adjudication method for the test set is described or implied in the provided text. The comparison was directly between the device's visual results and the RT-PCR results.

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

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is generally conducted for imaging AI devices to evaluate the impact of AI assistance on human reader performance. The Nano-Check Influenza+COVID-19 Dual Test is an in vitro diagnostic device for antigen detection, not an imaging AI device where human readers interpret complex images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device.

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

Yes, the performance presented for the Nano-Check Influenza+COVID-19 Dual Test in the clinical study is essentially standalone performance in the context of a rapid diagnostic test. While the test is visually interpreted by an operator, the performance metrics (PPA and NPA) are derived from the direct output of the device compared to the RT-PCR reference. There is no complex "algorithm" separate from the physical test strips' chemical reaction and visual readout. The operator simply reads the result displayed by the device. The "human-in-the-loop" here is the visual interpretation of a clear positive/negative line, not a complex decision-making process aided by AI.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical performance study was an FDA-cleared molecular assay (RT-PCR method). This is a highly sensitive and specific laboratory-based test considered the gold standard for detecting viral nucleic acids, making it appropriate for establishing true positive and true negative cases of infection.

8. The Sample Size for the Training Set

The provided document describes the performance data for the test set (clinical study and analytical validation). It does not specify a separate training set sample size. This is expected because the Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunoassay, not a machine learning or AI model that requires a distinct training phase with a labeled dataset. The development and optimization of such assays rely on biochemical and immunological principles, followed by rigorous analytical and clinical validation.

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

As noted above, there isn't a "training set" in the machine learning sense for this type of IVD device. The development of the assay (e.g., selecting antibodies, optimizing reagents) would involve internal R&D studies, using characterized viral samples and clinical specimens, but these are part of the development process rather than a formal "training set" with ground truth establishment for an AI algorithm. The performance data presented is from the validation against established reference methods.

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The Nano-Check™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of SARS-CoV-2 nucleoprotein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 4 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Nano-Check™ COVID-19 Antigen Test and followed up with a molecular test.

The test does not differentiate between SARS-CoV or SARS-CoV-2.

A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Performance characteristics for SARS-CoV-2 were established during the 2022-2023 SARS-CoV-2 pandemic when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.

The Nano-Check™ COVID-19 Antigen Test is an immunochromatographic assay for detection of extracted SARS-CoV-2 nucleoprotein antigens in human anterior nasal swab specimens.

The assay kit consists of 20 test cassette devices, 20 reagent tubes containing extraction buffer for Set A or 20 empty reagent tubes and 20 ampules containing extraction buffer for Set B, 20 anterior nasal specimen collection swabs, one positive control swab, one negative control swab and an Instructions for Use/Quick Reference Instruction. An external positive control swab is used with recombinant SARS-CoV-2 nucleocapsid dried onto the swab and an external negative control swab contains blank universal viral transport media dried on the swab. The kit should be stored at 2°C - 30°C.

Here's an analysis of the acceptance criteria and the study that proves the Nano-Check COVID-19 Antigen Test meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for clinical performance are implicitly derived from the reported Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA). While explicit numerical acceptance targets are not stated, the device's performance is presented in comparison to a molecular RT-PCR test.

For analytical performance, acceptance criteria are generally "no interference" for cross-reactivity and endogenous/exogenous interference, and "100% agreement" for precision and reproducibility at moderate to high concentrations.

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

• Sample Size (Clinical Study Test Set): 670 subjects
• Data Provenance: Multi-center, prospective clinical study in the U.S. in 2022-2023. At the time of the study, the SARS-CoV-2 Omicron variant was the predominant strain.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical study. The ground truth was established using an "FDA Cleared SARS-CoV-2 RT-PCR Test as comparator." RT-PCR tests are molecular diagnostic methods and are considered the gold standard for SARS-CoV-2 detection, generally not requiring expert interpretation for generating positive/negative results.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1, none) for discordant results between the Nano-Check COVID-19 Antigen Test and the RT-PCR comparator. The results are presented directly from this comparison.

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

There was no MRMC comparative effectiveness study and no mention of AI or human readers being assisted by AI in this context. This device is a visually-read, lateral flow immunochromatographic assay, meaning results are interpreted directly by the user looking at control and test lines.

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

This is not applicable as the device is a visually-read assay. There is no algorithm for standalone performance. The interpretation is directly by the user.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for the clinical study was an FDA Cleared SARS-CoV-2 RT-PCR Test. This is considered the molecular "gold standard" for detecting the presence of SARS-CoV-2 viral RNA.

8. The Sample Size for the Training Set

The document does not report a sample size for a training set. This is expected as the Nano-Check COVID-19 Antigen Test is a traditional immunoassay, not an AI/machine learning-based device that typically requires a training set. The "training" of such a device is in its biochemical formulation and physical design, not in data-driven algorithm optimization.

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

As no training set is mentioned or applicable for this type of device, this information is not provided.

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The In Vitro Nano-Check ™ AMI cTnI Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl) in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).

The In Vitro Nano-Check ™ AMI cTnl Test is a qualitative assay, which cannot monitor the rise and fall of cTnl in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other test results and patient clinical findings.

Not Found

The provided text is a 510(k) premarket notification approval letter for the "In Vitro Nano-Check™ AMI cTnI Cardiac Marker Test". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, expert qualifications, ground truth establishment, or any other specifics related to a device performance study.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study details based on the provided input. The document is an FDA approval letter, not a study report.

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