(368 days)
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% |
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.