PTC · Uric Acid Test System For At Home Prescription Use
Clinical Chemistry · 21 CFR 862.1775 · Class 1
Overview
| Product Code | PTC |
|---|---|
| Device Name | Uric Acid Test System For At Home Prescription Use |
| Regulation | 21 CFR 862.1775 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242209 | UASure II Blood Uric Acid Monitoring System | Apex BioTechnology Corp. | Apr 4, 2025 | SESE |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System | Taidoc Technology Corporation | Dec 10, 2018 | SESE |
| K160990 | Nova Max Uric Acid Monitoring System | Nova Biomedical Corporation | Apr 11, 2017 | SESE |
Top Applicants
- Apex BioTechnology Corp. — 1 clearance
- Nova Biomedical Corporation — 1 clearance
- Taidoc Technology Corporation — 1 clearance
