DeviceClearance

Product code PTC— Clinical Chemistry

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System

Classification name
Uric Acid Test System For At Home Prescription Use
Device class
Class 1
Regulation
21 CFR 862.1775
Advisory panel
Clinical Chemistry
Total cleared
3
First cleared
Most recent

FDA classification definition

“For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.”

— U.S. Food and Drug Administration, device classification record for product code PTC under 21 CFR 862.1775, via openFDA

Market context for product code PTC

FDA has cleared 3 devices under product code PTC between 2017 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code PTC

Recent clearances under product code PTC

Data sourced from openFDA. This site is unofficial and independent of the FDA.