FDA product code PTC: Uric Acid Test System For At Home Prescription Use
PTC is the FDA product code for uric acid test system for at home prescription use. It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under PTC, 1 in the last five years, from 3 different applicants. The average 510(k) review took 262 days (median 249); 249 days on average over the last three years. FDA has posted 2 recalls for PTC devices, 2 initiated in the last five years.
Definition
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Classification
| Field | Value |
|---|---|
| Device name | Uric Acid Test System For At Home Prescription Use |
| Device class | Class I |
| Regulation | 21 CFR 862.1775 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PTC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 368 |
| 2018 | 1 | 168 |
| 2025 | 1 | 249 |
Compare with all 510(k) review times · Search every PTC clearance
Top PTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apex BioTechnology Corp. | 1 | 2025-04-04 |
| Taidoc Technology Corporation | 1 | 2018-12-10 |
| Nova Biomedical Corporation | 1 | 2017-04-11 |
Most recent PTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242209 | Apex BioTechnology Corp. | UASure II Blood Uric Acid Monitoring System | 2025-04-04 | 249 |
| K181675 | Taidoc Technology Corporation | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System | 2018-12-10 | 168 |
| K160990 | Nova Biomedical Corporation | Nova Max Uric Acid Monitoring System | 2017-04-11 | 368 |
Recalls for PTC devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-10-04.
| Year | Recalls |
|---|---|
| 2023 | 2 |
Frequently asked questions
What is FDA product code PTC?
PTC is the FDA product code for uric acid test system for at home prescription use. It is a Class I device, regulated under 21 CFR 862.1775 and reviewed by the Clinical Chemistry panel.
What device class is PTC?
Class I, regulation 21 CFR 862.1775. Typical premarket route: 510(k).
How long does a 510(k) take for product code PTC?
Across 3 cleared submissions the average was 262 days from receipt to decision (median 249).
Which companies have the most PTC clearances?
Apex BioTechnology Corp. (1); Taidoc Technology Corporation (1); Nova Biomedical Corporation (1).
Have PTC devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2023-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code PTC
- Run a recall and safety report across every PTC manufacturer
- Watch product code PTC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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