FDA product code GTY: Antigens, All Groups, Streptococcus Spp.
GTY is the FDA product code for antigens, all groups, streptococcus spp.. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 44 510(k) submissions under GTY, 3 in the last five years, from 29 different applicants. The average 510(k) review took 101 days (median 86); 132 days on average over the last three years. FDA has posted 20 recalls for GTY devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, All Groups, Streptococcus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for GTY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 174 |
| 2022 | 1 | 210 |
| 2025 | 1 | 177 |
| 2026 | 1 | 87 |
Compare with all 510(k) review times · Search every GTY clearance
Top GTY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Princeton BioMeditech Corp. | 4 | 2008-10-06 |
| Quidel Corporation | 3 | 2017-12-21 |
| Sa Scientific, Inc. | 3 | 2002-10-17 |
| Scientific Device Laboratory, Inc. | 3 | 1984-03-23 |
| ACON Laboratories, Inc. | 2 | 2025-11-26 |
24 more applicants have GTY clearances. See the full list in Caduvo.
Most recent GTY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260342 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Strep A Rapid Test | 2026-04-30 | 87 |
| K251697 | ACON Laboratories, Inc. | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | 2025-11-26 | 177 |
| K212623 | Healgen Scientific,, LLC | Healgen Strep A Rapid Test Strip (Throat Swab) | 2022-03-16 | 210 |
| K171976 | Quidel Corporation | Sofia Strep A+ FIA, Sofia 2 Analyzer | 2017-12-21 | 174 |
| K141775 | Quidel Corporation | SOFIA (R) STREP A+ FIA | 2014-12-16 | 168 |
Recalls for GTY devices
20 product recalls in 12 recall events; 13 initiated in the last five years and 13 still open. Most recent: 2026-04-06.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 6 |
| 2025 | 5 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code GTY?
GTY is the FDA product code for antigens, all groups, streptococcus spp.. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is GTY?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTY?
Across 44 cleared submissions the average was 101 days from receipt to decision (median 86).
Which companies have the most GTY clearances?
Princeton BioMeditech Corp. (4); Quidel Corporation (3); Sa Scientific, Inc. (3); Scientific Device Laboratory, Inc. (3); ACON Laboratories, Inc. (2).
Have GTY devices been recalled?
Yes: 20 product recalls across 12 recall events; the most recent began 2026-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code GTY
- Run a recall and safety report across every GTY manufacturer
- Watch product code GTY 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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