Submission Details
| 510(k) Number | K242209 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 2024 |
| Decision Date | April 04, 2025 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
UASure II Blood Uric Acid Monitoring System
Apr 2025
Decision
249d
Days
Class 1
Risk
About This 510(k) Submission
K242209 is an FDA 510(k) clearance for the UASure II Blood Uric Acid Monitoring System, a Uric Acid Test System For At Home Prescription Use (Class I — General Controls, product code PTC), submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 4, 2025, 249 days after receiving the submission on July 29, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1775.
Device Classification
| Product Code | PTC — Uric Acid Test System For At Home Prescription Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1775 |
| Definition | For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only. |
Manufacturer
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