Apex BioTechnology Corp. · Class I · Cleared Apr 4, 2025
| K-number | K242209 |
| Device name | UASure II Blood Uric Acid Monitoring System |
| Applicant | Apex BioTechnology Corp. |
| Product code | PTC |
| Device class | Class I |
| Decision date | Apr 4, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 862.1775 |
The UASure II Blood Uric Acid Monitoring System measures blood uric acid levels from capillary fingertip samples for home use by prescription. It is intended for self-testing by people with gout to monitor uric acid control, but does not diagnose hyperuricemia or gout and should not be used to make medication changes without consulting a doctor.
The device uses amperometry methodology, where uric acid in blood is oxidized to generate current at an electrode. The current generated is proportional to uric acid concentration, allowing quantification by measuring the generated current.
Not stated in this summary.
Clinical and non-clinical testing demonstrated that the UASure II performs substantially equivalent to the predicate Nova Max Uric Acid Monitoring System. An accuracy study with home users using finger capillary whole blood showed equivalent performance, and comprehensive non-clinical testing including linearity, precision, repeatability, stability, interference, and hematocrit performance testing all confirmed substantial equivalence to current methods for uric acid measurement.
View the full FDA submission: accessdata.fda.gov