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510(k) Data Aggregation
(249 days)
PTC
This UASure II Blood Uric Acid Monitoring System measures blood uric acid levels in fresh capillary whole blood drawn from fingertips. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of uric acid control.
The UASure II Blood Uric Acid Monitoring System helps track uric acid levels but does not diagnose Hyperuricemia or Gout. Do not change medications based on test results without talking to a doctor.
The UASure II Blood Uric Acid Monitoring System includes the UASure II Meter, UASure II Blood Uric Acid Test Strips and UASure II Uric Acid Control Solution.
The UASure II Blood Uric Acid Monitoring System consists of the UASure II Blood Uric Acid Meter, UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution. It is used for testing of blood uric acid by self-testers at home use by prescription only. The UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution are purchased separately.
The provided FDA 510(k) clearance letter for the UASure II Blood Uric Acid Monitoring System details its intended use and general regulatory information. However, it does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the comprehensive manner requested.
The document only broadly states:
- "Non-Clinical Testing: [...] results demonstrate substantial equivalence to the current methods for uric acid measurements."
- "Clinical Testing: An accuracy study was conducted with home users using finger capillary whole blood. Results demonstrate substantial equivalence to the predicate system."
- "Conclusion: Clinical and analytical testing demonstrated that the UASure II Blood Uric Acid Monitoring System perform in a substantially equivalent manner to that of the predicate."
To answer your request comprehensively, information typically found in the applicant's submission (e.g., the 510(k) summary with more detailed study results, or the actual study reports) would be necessary. This includes:
- A table of acceptance criteria and reported device performance: This would typically involve specific statistical metrics (e.g., bias, precision, correlation coefficient, Bland-Altman agreement) and their acceptable ranges, and the actual results from the study. The document does not provide these specific numbers.
- Sample size used for the test set and data provenance: The document indicates "home users using finger capillary whole blood" but does not specify the number of samples or whether the data was retrospective or prospective, or the country of origin.
- Number of experts used to establish ground truth and qualifications: This is not applicable in this context as this is not an imaging AI device requiring expert reads, but rather a blood diagnostic device where ground truth is established by a reference method/laboratory.
- Adjudication method: Not applicable for this type of device. Ground truth is typically a direct measurement from a reference method.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable for this type of in-vitro diagnostic device. MRMC studies are specific to imaging devices often involving human interpretation.
- Standalone (algorithm only) performance: For this device, "standalone performance" is essentially the device's accuracy when measuring uric acid, which is compared to a reference method. The letter states "results demonstrate substantial equivalence to the predicate system" but lacks specifics.
- Type of ground truth used: For a blood uric acid monitoring system, the ground truth would be established by a well-calibrated, high-precision laboratory reference method for uric acid measurement. The document doesn't explicitly state what reference method was used.
- Sample size for the training set: This refers to the data used to develop the device/algorithm. This information is not present in the clearance letter.
- How ground truth for the training set was established: Similar to point 8, this information is not provided.
In summary, based solely on the provided FDA 510(k) clearance letter, I cannot provide the detailed information requested regarding the acceptance criteria and the specific study results proving the device meets them. The letter serves as an official clearance notice, confirming substantial equivalence, but generally does not include the granular data from the performance studies.
Ask a specific question about this device
(168 days)
PTC
Prescription home use: The FORA MD6 Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. It is intended foruse outside the body (in vitro diagnostic use) by people with hyperuricemia or gout as an aid to monitor the effectiveness of uric acid control. The system is intended for single-patient home use by prescription only and should not be shared. The system should only be used with FORA MD6 Uric Acid Test Strips, and FORA Uric Acid Control Solutions.
The system should not be used to alter hyperuricemia or gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional.
Point-of-care use: The FORA MD6 Pro Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. This system should only be used with single-use, auto-disabling lancing devices. It is for in vitro diagnostic use only.
This system is intended for multiple patient use by health care professionals at point of care sites as an aid to monitor the effectiveness of uric acid control in people with hyperuricemia or gout
FORA MD6/ FORA MD6 Pro Uric Acid Monitoring System includes the FORA MD6/ FORA MD6 Pro Meter, the FORA MD6/ FORA MD6 Pro Uric Acid Test Strips and the Uric Acid Control Solutions.
The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets those criteria. It is a 510(k) summary for the FORA MD6 Uric Acid Monitoring System and FORA MD6 Pro Uric Acid Monitoring System, which states that performance studies were conducted, but it does not specify the acceptance criteria or report the detailed performance metrics from those studies.
Therefore, I cannot provide the requested information based on the given input. The document generally states that the studies "demonstrated that the intended users can obtain uric acid results that are substantially equivalent to the current methods for uric acid measurements," but it lacks specific quantitative acceptance criteria and detailed performance data.
Ask a specific question about this device
(368 days)
PTC
The Nova Max Uric Acid Monitoring System consists of Nova Max Uric Acid Monitor, Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions. The Nova Max Uric Acid Monitoring System is intended to the quantitative measurement of Uric Acid in fresh capillary whole blood obtained from the fingertip of gout patients. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of Uric Acid control. It is intended for use by patients undergoing treatment for gout or the order of a treating healthcare professional. This system should not be used to alter gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional. This system should only be used with single-use, auto-disabling Lancing Devices. It should only be used with Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions.
The Nova Max Uric Acid Monitoring System uses selective mediated enzymatic action (uricase biosensor) to generate current across the electrodes. The current generated is proportional to the concentration of Uric Acid in the whole blood sample. The device, which is amperometric, measures the Uric Acid concentration in the whole blood sample by measuring the amount of current that was generated and flows through the electrodes on the Test Strips.
The Nova Max Uric Acid Monitoring System is comprised of Nova Max Uric Acid Test Strips, a portable handheld Nova Max Uric Acid Monitor, and Nova Max Uric Acid Control Solutions.
Monitor Power Supply: The monitor uses single (3V) lithium, non-rechargeable battery. The battery life is approximately 1,000 tests.
No-Coding System: The user is not required to enter a Test Strip lot-specific Calibration Code into the monitor by pressing a button or by inserting a Code Key.
Uric Acid Control Solutions are aqueous assayed solutions, containing buffered Uric Acid, preservatives, FD & C dye, and viscosity additive. They contain no products of human origin. There are three levels of controls (level 1, 2, and 3).
Safety Lancets are provided as an accessory to the Nova Max Uric Acid Monitoring System. They are commercially available single-use, auto disabling sterilized Lancing Devices.
Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text:
Device Name: Nova Max Uric Acid Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Study Accuracy | |
| Linear Regression Correlation Coefficient (R²) ≥ 0.95 | The "Clinical Study Conclusion" states: "The results of the layperson clinical study confirmed that the Nova Max Uric Acid Monitoring System is safe and effective for the intended use populations (persons diagnosed with Gout) and the Nova Max Uric Acid Monitoring System is substantially equivalent to the predicate device." While a specific R² value isn't explicitly stated in the summary, the conclusion implies this criterion was met. |
| Linear Regression Slope of 0.94 - 1.06 | As above, the clinical study conclusion indicates this criterion was met, even if the specific numerical result is not in the provided text. |
| Bench Testing (Sample Criteria) | |
| Precision: Within-run CV% |
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