GMQ · Class II · 21 CFR 866.3820

FDA Product Code GMQ: Antigens, Nontreponemal, All

Leading manufacturers include Gold Standard Diagnostics, LLC.

32
Total
32
Cleared
123d
Avg days
1981
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 256d recently vs 119d historically

FDA 510(k) Cleared Antigens, Nontreponemal, All Devices (Product Code GMQ)

32 devices
1–24 of 32
Cleared Oct 10, 2025
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
K250249
Gold Standard Diagnostics, LLC
Microbiology · 256d

About Product Code GMQ - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code GMQ since 1981, with 32 receiving FDA clearance (average review time: 123 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

Recent submissions under GMQ have taken an average of 256 days to reach a decision - up from 119 days historically. Manufacturers should account for longer review timelines in current project planning.

GMQ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →