PTC · Class I · 21 CFR 862.1775

FDA Product Code PTC: Uric Acid Test System For At Home Prescription Use

For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only.

Leading manufacturers include Apex BioTechnology Corp..

3
Total
3
Cleared
262d
Avg days
2017
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 249d avg (recent)

FDA 510(k) Cleared Uric Acid Test System For At Home Prescription Use Devices (Product Code PTC)

3 devices
1–3 of 3
Cleared Apr 04, 2025
UASure II Blood Uric Acid Monitoring System
K242209
Apex BioTechnology Corp.
Chemistry · 249d

About Product Code PTC - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code PTC since 2017, with 3 receiving FDA clearance (average review time: 262 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for PTC submissions have been consistent, averaging 249 days recently vs 268 days historically.

PTC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →