FDA product code QYT: Over-The-Counter Covid-19 Antigen Test
QYT is the FDA product code for over-the-counter covid-19 antigen test. It is a Class II device, regulated under 21 CFR 866.3984 and reviewed by the Microbiology panel. FDA has cleared 14 510(k) submissions under QYT, 14 in the last five years, from 13 different applicants. The average 510(k) review took 177 days (median 161); 170 days on average over the last three years. FDA has posted 3 recalls for QYT devices, 3 initiated in the last five years.
Definition
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Classification
| Field | Value |
|---|---|
| Device name | Over-The-Counter Covid-19 Antigen Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3984 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QYT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 227 |
| 2024 | 5 | 179 |
| 2025 | 5 | 183 |
| 2026 | 3 | 147 |
Compare with all 510(k) review times · Search every QYT clearance
Top QYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ACON Laboratories, Inc. | 2 | 2024-04-19 |
| Assure Tech., LLC | 1 | 2026-06-05 |
| Healgen Scientific,, LLC | 1 | 2026-04-13 |
| Genbody.Inc. | 1 | 2026-03-13 |
| InBios International, Inc. | 1 | 2025-10-12 |
8 more applicants have QYT clearances. See the full list in Caduvo.
Most recent QYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260754 | Assure Tech., LLC | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test | 2026-06-05 | 88 |
| K260095 | Healgen Scientific,, LLC | Heal-Check Rapid COVID-19 Antigen Self-Test | 2026-04-13 | 90 |
| K251916 | Genbody.Inc. | GenBody COVID-19 Ag Home Test | 2026-03-13 | 263 |
| K251595 | InBios International, Inc. | COVID-19 Detect Rapid Self -Test | 2025-10-12 | 138 |
| K251753 | Genabio Diagnostics, Inc. | GenaCheck COVID-19 Rapid Self-Test | 2025-09-05 | 88 |
Recalls for QYT devices
3 product recalls in 1 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-06-26.
| Year | Recalls |
|---|---|
| 2024 | 3 |
Frequently asked questions
What is FDA product code QYT?
QYT is the FDA product code for over-the-counter covid-19 antigen test. It is a Class II device, regulated under 21 CFR 866.3984 and reviewed by the Microbiology panel.
What device class is QYT?
Class II, regulation 21 CFR 866.3984. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYT?
Across 14 cleared submissions the average was 177 days from receipt to decision (median 161).
Which companies have the most QYT clearances?
ACON Laboratories, Inc. (2); Assure Tech., LLC (1); Healgen Scientific,, LLC (1); Genbody.Inc. (1); InBios International, Inc. (1).
Have QYT devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2024-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code QYT
- Run a recall and safety report across every QYT manufacturer
- Watch product code QYT 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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