FDA product code GQG: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
GQG is the FDA product code for antigen, cf (including cf controls), respiratory syncytial virus. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel. FDA has cleared 32 510(k) submissions under GQG, 2 in the last five years, from 23 different applicants. The average 510(k) review took 105 days (median 92); 151 days on average over the last three years. FDA has posted 3 recalls for GQG devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3480 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for GQG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 128 |
| 2024 | 1 | 180 |
| 2026 | 1 | 122 |
Compare with all 510(k) review times · Search every GQG clearance
Top GQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson & CO | 3 | 2013-11-15 |
| Quidel Corp. | 3 | 2013-08-13 |
| Abbott Laboratories | 3 | 1988-06-22 |
| Becton, Dickinson and Company | 2 | 2013-11-07 |
| Binax, Inc. | 2 | 2003-10-21 |
18 more applicants have GQG clearances. See the full list in Caduvo.
Most recent GQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253318 | Hangzhou Clongene Biotech Co., Ltd. | Clungene RSV Antigen Rapid Test | 2026-01-30 | 122 |
| K240280 | Nano-Ditech Corporation | Nano-Check RSV Test | 2024-07-30 | 180 |
| K162911 | Quidel Corporation | Sofia RSV FIA on Sofia 2 analyzer | 2017-02-22 | 128 |
| K133140 | Becton, Dickinson & CO | BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV | 2013-11-15 | 29 |
| K132456 | Becton, Dickinson and Company | BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV | 2013-11-07 | 93 |
Recalls for GQG devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-03-28.
Frequently asked questions
What is FDA product code GQG?
GQG is the FDA product code for antigen, cf (including cf controls), respiratory syncytial virus. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel.
What device class is GQG?
Class I, regulation 21 CFR 866.3480. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GQG?
Across 32 cleared submissions the average was 105 days from receipt to decision (median 92).
Which companies have the most GQG clearances?
Becton, Dickinson & CO (3); Quidel Corp. (3); Abbott Laboratories (3); Becton, Dickinson and Company (2); Binax, Inc. (2).
Have GQG devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2007-03-28.
Next steps
- Run an FDA pathway report with predicate devices for product code GQG
- Run a recall and safety report across every GQG manufacturer
- Watch product code GQG 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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