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The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Health Monitoring System (Cue Cartridge Reader) for the rapid, qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic).

A negative test result is presumptive, and it is recommended these results be confirmed by a lab-based molecular SARS-CoV-2 assay if necessary for patient management. Negative results do not preclude SARS-CoV-2 infections 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.

This test is intended to be sold over-the-counter (OTC) for testing of individuals 18 years of age and older.

The Cue Health Monitoring System consists of the Cue Cartridge Reader, charging cable and power adapter. The Cue Cartridge Reader is an automated analyzer for use with Cue cartridges and the Cue Health App installed on a mobile smart device (e.q., Apple® iPhone®, Android™) to perform in vitro diagnostic testing. The Cue system is designed to be an easy-to-use, portable testing device for use at home and in point-of-care CLIA Waived settings. Cue cartridges contain the reagents and associated materials required for sample testing which occurs inside the cartridge. Sample analysis takes place within the Cue Cartridge Reader and the test result is wirelessly sent to the user's mobile smart device. The Cue test result is displayed to the user in the Cue Health App installed on a compatible mobile smart device. The main steps for using the Cue Cartridge Reader with the Cue COVID-19 Molecular Test Cartridge are: (1) install the Cue Health App on a compatible mobile smart device and register for a Cue Health App account; (2) connect the mobile smart device with the Cue Cartridge Reader (this allows for the test result to be sent to the particular mobile smart device); (3) insert the Cue COVID-19 Molecular Test Cartridge into the Cue Cartridge Reader; (4) collect a nasal sample using the Cue Sample Wand; and (5) insert the Cue Sample Wand with nasal sample into the Cue COVID-19 Molecular Test Cartridge. Testing starts automatically once the Cue Sample Wand is inserted into the cartridge and proceeds without intervention from the user. When the test is completed, the Cue test result is automatically sent to the user's mobile smart device via BLUETOOTH® technology and displayed to the user in the Cue Health App installed on the mobile smart device.

The Cue Sample Wand: The Cue Sample Wand is a single-use, sterile, disposable swab used for collection of a nasal swab sample from the anterior of the human nose. The Wand is comprised of a plastic wand handle and flocked tip. The flock fiber material, fiber adhesive, and handle have been tested for biocompatibility.

The Cue COVID-19 Molecular Test Cartridge: The Cue COVID-19 Molecular Test Cartridge contains the reagents and associated materials required for detection of COVID-19 in nasal samples collected using the Cue Sample Wand. Each cartridge contains an internal control that controls for the process steps of the Cue test (e.g., sample collection, pellet mixing, amplification). Testing takes place within the cartridge. Testing duration is approximately 20 minutes from Sample Wand insertion to results.

The Cue COVID-19 Molecular Test Cartridge and the sterile Cue Sample Wand are packaged together; both are single-use only.

The Cue Health App: The Cue Cartridge Reader interfaces with the user through the Cue Health App installed on the user's mobile smart device. The Cue Health App enables the user to create a Cue Health App account and connect the mobile smart device to the Cue Cartridge Reader. The Cue Health App also provides the user with the precautions and limitations of the Cue COVID-19 Molecular Test, video tutorials for sample collection and running the test, and is the primary display of the test results.

The provided text describes a 510(k) premarket notification for the Cue COVID-19 Molecular Test. The application is for a device that is essentially the same as a previously cleared predicate device (Cue COVID-19 Molecular Test, DEN220028). The only stated difference between the candidate device and the predicate device is an expanded stability claim for storage temperature.

Crucially, the document explicitly states: "Performance Established in DEN220028" and "Same" for Performance in Table 1. This means the clinical performance criteria and the study that proves the device meets those criteria were established and presented in the original De Novo classification for the predicate device (DEN220028). This 510(k) application (K232643) relies on that previous performance data and only presents a multi-lot reagent stability study to support the expanded temperature claim.

Therefore, the provided document does not contain the detailed information requested regarding the original clinical performance study, acceptance criteria, sample sizes, expert qualifications, etc., for the device's diagnostic accuracy. It only discusses the stability study.

Based only on the provided text, I can infer the following about the acceptance criteria and the study that proves the device meets them:

The core of the acceptance criteria for diagnostic performance was presumably established and met during the De Novo classification of the predicate device (DEN220028). This 510(k) relies on the substantial equivalence to that predicate, with additional data just for the stability claim.

**However, the document does not provide the following information for the diagnostic performance: **

• 1. A table of acceptance criteria and the reported device performance (for diagnostic accuracy)
• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (given it's a molecular test, this isn't directly applicable in the same way as an imaging AI but refers to the device's self-contained output accuracy)
• 7. The type of ground truth used (for diagnostic accuracy)
• 8. The sample size for the training set (if applicable for a molecular test, which often doesn't have a traditionally "trained" AI model in the imaging sense)
• 9. How the ground truth for the training set was established

What the provided text does describe (regarding the stability study):

• Acceptance Criteria (for Stability): "Cartridge stability was evaluated by the agreement with the negative or positive results expected for the testing panel." While not a quantitative criterion, this implies a requirement for consistent and accurate results (positive and negative) over time and at the new temperature range.
• Reported Device Performance (for Stability): "The real-time stability study results support expiration dating of up to three months after manufacture."
• Sample Size (for Stability): "Three different lots were tested monthly." (The exact number of cartridges per lot tested is not specified.)
• Data Provenance (for Stability): Not explicitly stated, but assumed to be internal laboratory testing by Cue Health Inc. (prospective).
• Experts/Ground Truth (for Stability): The ground truth for the stability study would be the known positive/negative status of the testing panel used. This does not involve human expert consensus in the way an imaging study would.
• No MRMC, Standalone, or Training Set information for Stability.

In summary, the provided document is a 510(k) summary for a substantially equivalent device, relying on the performance data from its predicate device (DEN220028). It only details a stability study, not the clinical diagnostic performance study. To get the full information on acceptance criteria and performance data, one would need to consult the De Novo classification details for DEN220028.

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The Cue COVID-19 Molecular Test is a nucleic acid amplification assay that is used with the Cue Health Monitoring System (Cue Cartridge Reader) for the rapid, qualitative detection of SARS-CoV-2 nucleic acid directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 (i.e., symptomatic).

A negative test result is presumptive, and it is recommended these results be confirmed by a labbased molecular SARS-CoV-2 assay if necessary for patient management. Negative results do not preclude SARS-CoV-2 infections 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.

This test is intended to be sold over-the-counter (OTC) for testing of individuals 18 years of age and older.

The device consists of the Cue Health Monitoring System (Cue Reader), the Cue COVID-19 Molecular Test Cartridge, and the Cue sample wand. Users must first download and install the Cue Health App onto their mobile smart device. Users then create an account (first time use) and pair the Cue Reader with the mobile smart device. Multiple profiles can be set up under each user account. The appropriate profile is selected and the user inserts the Cue COVID-19 Molecular Test Cartridge into the Cue Reader. The Cue COVID-19 Molecular Test Cartridge must warm up prior to initiating a run. The user collects an anterior nasal swab sample by swabbing both nares with the Cue sample wand and then inserts the Cue sample wand nasal sample into the port of the Cue COVID-19 Molecular Test Cartridge. The test will start as soon as the Cue Sample Wand is inserted into the Cue COVID-19 Molecular Test Cartridge and is completed in 20 minutes. The Cue Health App will show the Cue COVID-19 Molecular Test result when the test is complete. The result is saved in the Cue Account profile that was selected before the test started.

The provided text describes the evaluation of the Cue COVID-19 Molecular Test for an automatic Class III designation (De Novo request). The FDA's decision summary details the device's characteristics, analytical and clinical performance, and risk assessments.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a dedicated table. However, based on the VI Performance Characteristics and C Clinical Studies sections, the core performance metrics evaluated are:

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance thresholds for all analytical performance metrics. For example, for precision, it simply presents the results. For LoD, the criterion "≥ 95% of the replicates tested are positive" is explicitly stated. For clinical performance, while specific targets are not given as "acceptance criteria," the reported PPA and NPA are high and fall within confidence intervals typical for FDA-authorized molecular tests for diagnostic purposes. The FDA's granting of the De Novo request implies that the performance met their internal criteria for Class II designation.

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

• Clinical Test Set Sample Size: 902 evaluable subjects.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study refers to SARS-CoV-2 variants circulating in the "United States" for in silico analysis, suggesting the clinical study likely involved US-based subjects/sites. The manufacturer, "Cue Health Inc.", is a US company.
  • Retrospective or Prospective: The clinical study was prospective. It states, "A prospective all-comer study enrolled subjects at 13 sites, from December 2020 - February 2021 and November 2021- February 2022 to evaluate the clinical performance..."

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 directly establishing the ground truth for the clinical test set. Instead, the ground truth was established by a "consensus comparator (agreement between at least two FDA Emergency Use Authorized (EUA) molecular tests for SARS-CoV-2)". This implies that these FDA EUA molecular tests served as the reference standard, rather than human experts adjudicating results.

For analytical performance studies (e.g., precision, LoD, cross-reactivity), the ground truth was established by carefully prepared samples with known concentrations of analytes (e.g., inactivated SARS-CoV-2, specific bacteria/viruses).

4. Adjudication Method for the Test Set

For the clinical test set, the adjudication method was a consensus comparator: "agreement between at least two FDA Emergency Use Authorized (EUA) molecular tests for SARS-CoV-2".

For analytical performance studies, the ground truth was based on the known composition and concentration of the spiked samples, not expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for the Cue COVID-19 Molecular Test. This device is an automated molecular test, not an AI intended to assist human readers in interpreting images or data. Therefore, a study to measure how much human readers improve with AI vs. without AI assistance is not applicable. The focus is on the standalone performance of the device and its usability by lay users.

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

Yes, the primary evaluation of the Cue COVID-19 Molecular Test is effectively a standalone (algorithm only without human-in-the-loop performance) study, though the "human-in-the-loop" here refers to the lay user operating the device and collecting the sample, rather than interpreting a complex output.

• The Analytical Performance section directly assesses the device's ability to detect SARS-CoV-2 nucleic acid independently (e.g., LoD, cross-reactivity, inclusivity).
• The Clinical Studies section compares the device's output (positive/negative) against a consensus comparator, reflecting its standalone diagnostic performance in a real-world setting with lay users performing the test steps but the device providing the result. The device itself interprets the signal and provides a qualitative result.

7. The Type of Ground Truth Used

• Clinical Study Ground Truth: Consensus comparator results from "at least two FDA Emergency Use Authorized (EUA) molecular tests for SARS-CoV-2." This is a strong, highly accurate reference standard for SARS-CoV-2 detection.
• Analytical Performance Study Ground Truth: Known concentrations of inactivated SARS-CoV-2 and other microorganisms/substances spiked into clinical nasal matrix or onto sample wands. This is a controlled, objective ground truth based on laboratory preparations.

8. The Sample Size for the Training Set

The document does not report specific sample sizes for a 'training set' for the Cue COVID-19 Molecular Test. This is because the described studies are verification and validation studies for a new device (a molecular test), not for an AI/ML algorithm that typically requires distinct training, validation, and test datasets. The "development" or "training" of the underlying assay chemistry and instrument logic would have occurred prior to these outlined performance studies. The studies described here are to prove the device meets acceptance criteria, which typically uses a separate, held-out test set, not a training set.

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

As noted above, the document does not describe a distinct 'training set' or the establishment of its ground truth, consistent with the nature of a molecular diagnostic device evaluation rather than an AI/ML algorithm. The ground truth for all performance evaluations relies on the methods described in point 7 (consensus comparator for clinical, known spiked concentrations for analytical).

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