FDA product code GMQ: Antigens, Nontreponemal, All
GMQ is the FDA product code for antigens, nontreponemal, all. It is a Class II device, regulated under 21 CFR 866.3820 and reviewed by the Microbiology panel. FDA has cleared 32 510(k) submissions under GMQ, 1 in the last five years, from 26 different applicants. The average 510(k) review took 123 days (median 92); 256 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Nontreponemal, All |
| Device class | Class II |
| Regulation | 21 CFR 866.3820 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GMQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 157 |
| 2020 | 1 | 142 |
| 2025 | 1 | 256 |
Compare with all 510(k) review times · Search every GMQ clearance
Top GMQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arlington Scientific, Inc. (Asi) | 3 | 2020-10-21 |
| Oxoid U.S.A., Inc. | 3 | 1982-09-21 |
| Ampcor, Inc. | 2 | 1988-03-30 |
| Emd Chemicals, Inc. | 2 | 1983-09-12 |
| Gold Standard Diagnostics, LLC | 1 | 2025-10-10 |
21 more applicants have GMQ clearances. See the full list in Caduvo.
Most recent GMQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250249 | Gold Standard Diagnostics, LLC | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | 2025-10-10 | 256 |
| K201438 | Arlington Scientific, Inc. (Asi) | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | 2020-10-21 | 142 |
| K182391 | Arlington Scientific, Inc. (Asi) | ASI Automated ASI RPR Test for Syphilis on the ASI Evolution | 2018-11-30 | 87 |
| K173376 | Arlington Scientific, Inc. (Asi) | ASI Evolution | 2018-06-14 | 227 |
| K150358 | Gold Standard Diagnostics | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | 2015-11-12 | 273 |
Recalls for GMQ devices
openFDA lists no recalls for product code GMQ.
Frequently asked questions
What is FDA product code GMQ?
GMQ is the FDA product code for antigens, nontreponemal, all. It is a Class II device, regulated under 21 CFR 866.3820 and reviewed by the Microbiology panel.
What device class is GMQ?
Class II, regulation 21 CFR 866.3820. Typical premarket route: 510(k).
How long does a 510(k) take for product code GMQ?
Across 32 cleared submissions the average was 123 days from receipt to decision (median 92).
Which companies have the most GMQ clearances?
Arlington Scientific, Inc. (Asi) (3); Oxoid U.S.A., Inc. (3); Ampcor, Inc. (2); Emd Chemicals, Inc. (2); Gold Standard Diagnostics, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMQ
- Run a recall and safety report across every GMQ manufacturer
- Watch product code GMQ 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times