(90 days)
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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