PTC — Uric Acid Test System For At Home Prescription Use Class I
FDA product code PTC covers "Uric Acid Test System For At Home Prescription Use", a Class I medical device regulated under 21 CFR 862.1775. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PTC
- Device Class
- Class I
- Regulation Number
- 862.1775
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242209 | apex biotechnology | UASure II Blood Uric Acid Monitoring System | April 4, 2025 |
| K181675 | taidoc technology corporation | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System | December 10, 2018 |
| K160990 | nova biomedical corporation | Nova Max Uric Acid Monitoring System | April 11, 2017 |