GMQ · Class II · 21 CFR 866.3820

FDA Product Code GMQ: Antigens, Nontreponemal, All

Leading manufacturers include Arlington Scientific, Inc. (Asi), Oxoid U.S.A., Inc. and Emd Chemicals, Inc..

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
Cleared Oct 21, 2020
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
K201438
Arlington Scientific, Inc. (Asi)
Microbiology · 142d
Cleared Nov 30, 2018
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
K182391
Arlington Scientific, Inc. (Asi)
Microbiology · 87d
Cleared Jun 14, 2018
ASI Evolution
K173376
Arlington Scientific, Inc. (Asi)
Microbiology · 227d
Cleared Feb 23, 2000
SYNTHETIC VDRL ANTIGEN
K993633
Centers For Disease Control and Prevention
Microbiology · 119d
Cleared May 23, 1988
STANBIO SYPHILIS RPR TEST, NO. 1170
K880144
Stanbio Laboratory
Microbiology · 131d
Cleared Dec 12, 1986
SYPH-TRUST
K863368
I.A.F. Production, Inc.
Microbiology · 100d
Cleared Jul 26, 1984
RAPID PLASMA REAGIN CARD TEST
K842541
Clinical Sciences, Inc.
Microbiology · 24d
Cleared Mar 09, 1984
AUTOGROUPER 16C SYS AUTOMATED REAG
K834149
Technicon Instruments Corp.
Microbiology · 99d
Cleared Sep 12, 1983
TRUST RPR CARD TEST #65144
K832479
Emd Chemicals, Inc.
Hematology · 48d
Cleared Sep 12, 1983
TRUST RPR TITRATION CARD TEST #65145
K832480
Emd Chemicals, Inc.
Hematology · 48d
Cleared Sep 21, 1982
RAPID REAGIN CARD TEST
K822661
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Sep 21, 1982
REAGIN ANTIGEN SUSPENSION
K822662
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared Apr 14, 1982
TREP CARD EIKEN
K820567
Syn-Kit, Inc.
Microbiology · 43d
Cleared Nov 06, 1981
VDRL CARBON ANTIGEN
K812894
Oxoid U.S.A., Inc.
Microbiology · 22d
Cleared May 15, 1981
DADE RPR CARD TEST
K811152
American Dade
Microbiology · 18d
Cleared Mar 31, 1981
RPR CARD TEST SYSTEM
K810658
Beckman Instruments, Inc.
Immunology · 20d

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 510(k) Review Time - GMQ Product Code

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 →